{"id":"vincristine-sulfate-pfs","rwe":[{"pmid":"41718415","year":"2026","title":"Fluid Overload-Associated Large B-Cell Lymphoma Presenting as Isolated Pleural Effusion.","finding":"","journal":"Hematology reports","studyType":"Clinical Study"},{"pmid":"41608764","year":"2026","title":"Bispecific Antibodies Versus Chimeric Antigen Receptor T-Cell Therapy in Relapsed/Refractory Diffuse Large B-Cell Lymphoma: A Comparative Narrative Review of Efficacy, Safety, and Accessibility.","finding":"","journal":"Cancer medicine","studyType":"Clinical Study"},{"pmid":"41194119","year":"2025","title":"Probiotic-enhanced chemotherapy: Lactobacillus fermentum synergizes with vincristine to induce apoptosis via dual pathway activation in human cancer cells.","finding":"","journal":"Cancer cell international","studyType":"Clinical Study"},{"pmid":"41047434","year":"2025","title":"Combinational therapy of cervical cancer consisting of probiotic particles and vincristine: a molecular in vitro study.","finding":"","journal":"Medical oncology (Northwood, London, England)","studyType":"Clinical Study"}],"_fda":{"id":"436f7772-e507-45ab-be60-4da4e0c889a8","set_id":"49596de6-ab18-49d1-9e5b-30968fc21c36","openfda":{"unii":["T5IRO3534A"],"route":["INTRAVENOUS"],"rxcui":["1863343","1863354"],"spl_id":["436f7772-e507-45ab-be60-4da4e0c889a8"],"brand_name":["VinCRIStine Sulfate"],"spl_set_id":["49596de6-ab18-49d1-9e5b-30968fc21c36"],"package_ndc":["61703-309-06","61703-309-16"],"product_ndc":["61703-309"],"generic_name":["VINCRISTINE SULFATE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["VINCRISTINE SULFATE"],"manufacturer_name":["Hospira, Inc."],"application_number":["ANDA071484"],"is_original_packager":[true]},"version":"28","warnings":["WARNINGS This preparation is for intravenous use only. It should be administered by individuals experienced in the administration of Vincristine Sulfate Injection. The intrathecal administration of Vincristine Sulfate Injection usually results in death. To reduce the potential for fatal medication errors due to incorrect route of administration, Vincristine Sulfate Injection should be diluted in a flexible plastic container and prominently labeled as indicated \"FOR INTRAVENOUS USE ONLY – FATAL IF GIVEN BY OTHER ROUTES.\" See OVERDOSAGE section for the treatment of patients given intrathecal Vincristine Sulfate Injection. Pregnancy Vincristine sulfate can cause fetal harm when administered to a pregnant woman. When pregnant mice and hamsters were given doses of vincristine sulfate that caused resorption of 23% to 85% of fetuses, fetal malformations were produced in those that survived. Five monkeys were given single doses of vincristine sulfate between days 27 and 34 of their pregnancies; 3 of the fetuses were normal at term, and 2 viable fetuses had grossly evident malformations at term. In several animal species, vincristine sulfate can induce teratogenesis as well as embryo death at doses that are nontoxic to the pregnant animal. There are no adequate and well–controlled studies in pregnant women. If this drug is used during pregnancy or if the patient becomes pregnant while receiving this drug, she should be apprised of the potential hazard to the fetus. Women of child–bearing potential should be advised to avoid becoming pregnant."],"pregnancy":["Usage in Pregnancy See WARNINGS ."],"overdosage":["OVERDOSAGE Side effects following the use of Vincristine Sulfate Injection are dose related. In pediatric patients under 13 years of age, death has occurred following doses of vincristine sulfate that were 10 times those recommended for therapy. Severe symptoms may occur in this patient group following dosages of 3 to 4 mg/m 2 . Adults can be expected to experience severe symptoms after single doses of 3 mg/m 2 or more (see ADVERSE REACTIONS ). Therefore, following administration of doses higher than those recommended, patients can be expected to experience exaggerated side effects. Supportive care should include the following: (1) prevention of side effects resulting from the syndrome of inappropriate antidiuretic hormone secretion (preventive treatment would include restriction of fluid intake and perhaps the administration of a diuretic affecting the function of Henle's loop and the distal tubule); (2) administration of anticonvulsants; (3) use of enemas or cathartics to prevent ileus (in some instances, decompression of the gastrointestinal tract may be necessary); (4) monitoring the cardiovascular system; (5) determining daily blood counts for guidance in transfusion requirements. Folinic acid has been observed to have a protective effect in normal mice that were administered lethal doses of vincristine sulfate ( Cancer Res 1963;23:1390). Isolated case reports suggest that folinic acid may be helpful in treating humans who have received an overdose of vincristine sulfate. It is suggested that 100 mg of folinic acid be administered intravenously every 3 hours for 24 hours and then every 6 hours for at least 48 hours. Theoretically (based on pharmacokinetic data), tissue levels of vincristine sulfate can be expected to remain significantly elevated for at least 72 hours. Treatment with folinic acid does not eliminate the need for the above mentioned supportive measures. Most of an intravenous dose of vincristine is excreted into the bile after rapid tissue binding (see CLINICAL PHARMACOLOGY ). Because only very small amounts of the drug appear in dialysate, hemodialysis is not likely to be helpful in cases of overdosage. An increase in the severity of side effects may be experienced by patients with liver disease that is severe enough to decrease biliary excretion. Enhanced fecal excretion of parenterally administered vincristine has been demonstrated in dogs pretreated with cholestyramine. There are no published clinical data on the use of cholestyramine as an antidote in humans. There are no published clinical data on the consequences of oral ingestion of vincristine. Should oral ingestion occur, the stomach should be evacuated. Evacuation should be followed by oral administration of activated charcoal and a cathartic. Treatment of patients following intrathecal administration of Vincristine Sulfate Injection has included immediate removal of spinal fluid and flushing with Lactated Ringer's, as well as other solutions and has not prevented ascending paralysis and death. In one case, progressive paralysis in an adult was arrested by the following treatment initiated immediately after the intrathecal injection: 1. As much spinal fluid was removed as could be safely done through lumbar access. 2. The subarachnoid space was flushed with Lactated Ringer's solution infused continuously through a catheter in a cerebral lateral ventricle at the rate of 150 mL/h. The fluid was removed through a lumbar access. 3. As soon as fresh frozen plasma became available, the fresh frozen plasma, 25 mL, diluted in 1 L of Lactated Ringer's solution was infused through the cerebral ventricular catheter at the rate of 75 mL/h with removal through the lumbar access. The rate of infusion was adjusted to maintain a protein level in the spinal fluid of 150 mg/dL. 4. Glutamic acid, 10 g, was given intravenously over 24 hours followed by 500 mg 3 times daily by mouth for 1 month or until neurological dysfunction stabilized. The role of glutamic acid in this treatment is not certain and may not be essential."],"references":["REFERENCES 1. OSHA Hazardous Drugs. OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html"],"description":["DESCRIPTION Vincristine Sulfate Injection, USP is the salt of an alkaloid obtained from a common flowering herb, the periwinkle plant ( Vinca rosea Linn). Originally known as leurocristine, it has also been referred to as LCR and VCR. The molecular formula for Vincristine Sulfate, USP is C 46 H 56 N 4 O 10 ∙H 2 SO 4 . It has a molecular weight of 923.04. The structural formula is as follows: Vincristine Sulfate, USP is a white to off–white powder. It is soluble in methanol, freely soluble in water, but only slightly soluble in 95% ethanol. In 98% ethanol, Vincristine Sulfate, USP has an ultraviolet spectrum with maxima at 221 nm (∈+47,100). Vincristine Sulfate Injection, USP is a sterile, preservative–free, single-dose only solution available for intravenous use in 1 mg/mL and 2 mg/2 mL (1 mg/mL) vials. Each mL contains 1 mg Vincristine Sulfate, USP, 100 mg mannitol and Water for Injection, USP. Q.S. Sulfuric acid or sodium hydroxide have been added for pH control. The pH of Vincristine Sulfate Injection, USP ranges from 4.0 to 5.0. At the time of manufacture, the air in the containers is replaced by nitrogen. Chemical Structure"],"precautions":["PRECAUTIONS General Acute uric acid nephropathy, which may occur after the administration of oncolytic agents, has also been reported with vincristine sulfate. In the presence of leukopenia or a complicating infection, administration of the next dose of Vincristine Sulfate Injection warrants careful consideration. Treatment with vincristine sulfate in combination with other chemotherapy agents may cause myelosuppression. Monitor complete blood counts during treatment with vincristine sulfate (see Laboratory Tests below) and provide supportive care, including administration of hematopoietic growth factors, as clinically indicated. If central nervous system leukemia is diagnosed, additional agents may be required, because vincristine does not appear to cross the blood–brain barrier in adequate amounts. Particular attention should be given to dosage and neurologic side effects if Vincristine Sulfate Injection is administered to patients with preexisting neuromuscular disease and when other drugs with neurotoxic potential are also being used. Acute shortness of breath and severe bronchospasm have been reported following the administration of vinca alkaloids. These reactions have been encountered most frequently when the vinca alkaloid was used in combination with mitomycin–C and may require aggressive treatment, particularly when there is preexisting pulmonary dysfunction. The onset of these reactions may occur minutes to several hours after the vinca alkaloid is injected and may occur up to 2 weeks following the dose of mitomycin. Progressive dyspnea requiring chronic therapy may occur. Vincristine sulfate should not be readministered. Care must be taken to avoid contamination of the eye with concentration of Vincristine Sulfate Injection used clinically. If accidental contamination occurs severe irritation (or, if the drug was delivered under pressure, even corneal ulceration) may result. The eye should be washed immediately and thoroughly. The safety of immunization with live vaccines during treatment with vincristine sulfate has not been studied and vaccination with a live virus is not recommended during treatment with vincristine sulfate. Follow current vaccination practice guidelines for administration of live vaccines for patients who have received chemotherapy after completion of treatment with vincristine sulfate. Laboratory Tests Because dose–limiting clinical toxicity is manifested as neurotoxicity clinical evaluation (e.g., history, physical examination) is necessary to detect the need for dosage modification. Following administration of Vincristine Sulfate Injection, some individuals may have a fall in the white blood cell count or platelet count, particularly when previous therapy or the disease itself has reduced bone–marrow function. Therefore, a complete blood count should be done before administration of each dose. Acute elevation of serum uric acid may also occur during induction of remission in acute leukemia; thus, such levels should be determined frequently during the first 3 to 4 weeks of treatment or appropriate measures taken to prevent uric acid nephropathy. The laboratory performing these tests should be consulted for its range of normal values. Drug Interactions The simultaneous oral or intravenous administration of phenytoin and antineoplastic chemotherapy combinations that included vincristine sulfate has been reported to reduce blood levels of the anticonvulsant and to increase seizure activity. Dosage adjustment should be based on serial blood level monitoring. The contribution of vincristine sulfate to this interaction is not certain. The interaction may result from reduced absorption of phenytoin and an increase in the rate of its metabolism and elimination. Vincristine sulfate is a substrate for cytochrome P450 3A isozymes (CYP3A). Concurrent administration of vincristine sulfate with itraconazole or fluconazole (known inhibitors of the CYP3A metabolic pathway) has been reported to cause an earlier onset and/or an increased severity of neuromuscular side effects (see ADVERSE REACTIONS ). This interaction is presumed to be related to inhibition of the metabolism of vincristine. Therefore, the concomitant use of strong CYP3A inhibitors with vincristine sulfate should be avoided. Patients should be frequently monitored for adverse reactions with concomitant use of moderate CYP3A inhibitors (e.g., fluconazole) with vincristine sulfate. Concurrent use of strong CYP3A inducers (e.g., St. John's Wort) with vincristine sulfate should be avoided. Vincristine sulfate is also a substrate for P-glycoprotein (P-gp). Therefore, the concomitant use of P-gp inhibitors or inducers should be avoided. Carcinogenesis, Mutagenesis, Impairment of Fertility Neither in vivo nor in vitro laboratory tests have conclusively demonstrated the mutagenicity of this product. Fertility following treatment with vincristine sulfate alone for malignant disease has not been studied in humans. Clinical reports of both male and female patients who received multiple–agent chemotherapy that included vincristine sulfate indicate that azoospermia and amenorrhea can occur in postpubertal patients. Recovery occurred many months after completion of chemotherapy in some but not all patients. When the same treatment is administered to prepubertal patients, permanent azoospermia and amenorrhea are much less likely. Patients who received chemotherapy with vincristine sulfate in combination with anti–cancer drugs known to be carcinogenic have developed second malignancies. The contributing role of vincristine sulfate in this development has not been determined. No evidence of carcinogenicity was found following intraperitoneal administration of vincristine sulfate in rats and mice, although this study was limited. Usage in Pregnancy See WARNINGS . Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions due to vincristine sulfate in nursing infants, a decision should be made either to discontinue nursing or the drug, taking into account the importance of the drug to the mother. Pediatric Use See DOSAGE AND ADMINISTRATION section."],"how_supplied":["HOW SUPPLIED Vincristine Sulfate Injection, USP, is available as follows: Unit of Sale Total Strength/Total Volume (Concentration) NDC 61703–309–06 Carton of 1 single-dose flip-top vial (blue cap) 1 mg/mL NDC 61703–309–16 Carton of 1 single-dose flip-top vial (blue cap) 2 mg/2 mL (1 mg/mL) This product should be refrigerated between 2°C–8°C (36°F–46°F). Discard unused solution. Protect from light. Store Upright."],"boxed_warning":["WARNINGS Caution–This preparation should be administered by individuals experienced in the administration of Vincristine Sulfate Injection. It is extremely important that the intravenous needle or catheter be properly positioned before any vincristine is injected. Leakage into surrounding tissue during intravenous administration of Vincristine Sulfate Injection may cause considerable irritation. If extravasation occurs, the injection should be discontinued immediately, and any remaining portion of the dose should then be introduced into another vein. Local injection of hyaluronidase and the application of moderate heat to the area of leakage help disperse the drug and are thought to minimize discomfort and the possibility of cellulitis. FOR INTRAVENOUS USE ONLY – FATAL IF GIVEN BY OTHER ROUTES. See OVERDOSAGE section for the treatment of patients given intrathecal Vincristine Sulfate Injection.","WARNINGS This preparation is for intravenous use only. It should be administered by individuals experienced in the administration of Vincristine Sulfate Injection. The intrathecal administration of Vincristine Sulfate Injection usually results in death. To reduce the potential for fatal medication errors due to incorrect route of administration, Vincristine Sulfate Injection should be diluted in a flexible plastic container and prominently labeled as indicated \"FOR INTRAVENOUS USE ONLY – FATAL IF GIVEN BY OTHER ROUTES.\" See OVERDOSAGE section for the treatment of patients given intrathecal Vincristine Sulfate Injection."],"pediatric_use":["Pediatric Use See DOSAGE AND ADMINISTRATION section."],"effective_time":"20251230","nursing_mothers":["Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions due to vincristine sulfate in nursing infants, a decision should be made either to discontinue nursing or the drug, taking into account the importance of the drug to the mother."],"laboratory_tests":["Laboratory Tests Because dose–limiting clinical toxicity is manifested as neurotoxicity clinical evaluation (e.g., history, physical examination) is necessary to detect the need for dosage modification. Following administration of Vincristine Sulfate Injection, some individuals may have a fall in the white blood cell count or platelet count, particularly when previous therapy or the disease itself has reduced bone–marrow function. Therefore, a complete blood count should be done before administration of each dose. Acute elevation of serum uric acid may also occur during induction of remission in acute leukemia; thus, such levels should be determined frequently during the first 3 to 4 weeks of treatment or appropriate measures taken to prevent uric acid nephropathy. The laboratory performing these tests should be consulted for its range of normal values."],"adverse_reactions":["ADVERSE REACTIONS Prior to the use of this drug, patients and/or their parents/guardian should be advised of the possibility of untoward symptoms. In general, adverse reactions are reversible and are related to dosage. The most common adverse reaction is hair loss; the most troublesome adverse reactions are neuromuscular in origin. When single, weekly doses of the drug are employed, the adverse reactions of leukopenia, neuritic pain, and constipation occur but are usually of short duration (ie., less than 7 days). When the dosage is reduced, these reactions may lessen or disappear. The severity of such reactions seems to increase when the calculated amount of drug is given in divided doses. Other adverse reactions, such as hair loss, sensory loss, paresthesia, difficulty in walking, slapping gait, loss of deep–tendon reflexes, and muscle wasting, may persist for at least as long as therapy is continued. Generalized sensorimotor dysfunction may become progressively more severe with continued treatment. Although most such symptoms usually disappear by about the sixth week after discontinuance of treatment, some neuromuscular difficulties may persist for prolonged periods in some patients. Regrowth of hair may occur while maintenance therapy continues. The following adverse reactions have been reported: Hepatic veno-occlusive disease has been reported in patients receiving vincristine, particularly in pediatric patients, as part of standard combination chemotherapy regimens. Some of the patients had fatal outcomes; some who survived had undergone liver transplantation. Hypersensitivity – Rare cases of allergic–type reactions, such as anaphylaxis, rash and edema, that are temporally related to vincristine therapy have been reported in patients receiving vincristine as a part of multidrug chemotherapy regimens. Gastrointestinal – Constipation, abdominal cramps, weight loss, nausea, vomiting, oral ulceration, diarrhea, paralytic ileus, intestinal necrosis and/or perforation, and anorexia have occurred. Constipation may take the form of upper–colon impaction, and, on physical examination, the rectum may be empty. Colicky abdominal pain coupled with an empty rectum may mislead the physician. A flat film of the abdomen is useful in demonstrating this condition. All cases have responded to high enemas and laxatives. A routine prophylactic regimen against constipation is recommended for all patients receiving Vincristine Sulfate Injection. Paralytic ileus (which mimics the \"surgical abdomen\") may occur, particularly in young pediatric patients. The ileus will reverse itself with temporary discontinuance of Vincristine Sulfate Injection and with symptomatic care. Genitourinary – Polyuria, dysuria, and urinary retention due to bladder atony have occurred. Other drugs known to cause urinary retention (particularly in the elderly) should, if possible, be discontinued for the first few days following administration of Vincristine Sulfate Injection. Cardiovascular – Hypertension and hypotension have occurred. Chemotherapy combinations that have included vincristine sulfate, when given to patients previously treated with mediastinal radiation, have been associated with coronary artery disease and myocardial infarction. Causality has not been established. Neurologic – Frequently, there is a sequence to the development of neuromuscular side effects. Initially, only sensory impairment and paresthesia may be encountered. With continued treatment, neuritic pain and, later, motor difficulties may occur. There have been no reports of any agent that can reverse the neuromuscular manifestations that may accompany therapy with vincristine sulfate. Loss of deep–tendon reflexes, foot drop, ataxia, and paralysis have been reported with continued administration. Cranial nerve manifestations, such as isolated paresis and/or paralysis of muscles controlled by cranial motor nerves including potentially life–threatening bilateral vocal cord paralysis, may occur in the absence of motor impairment elsewhere; extraocular and laryngeal muscles are those most commonly involved. Jaw pain, pharyngeal pain, parotid gland pain, bone pain, back pain, limb pain, and myalgias have been reported; pain in these areas may be severe. Convulsions, frequently with hypertension, have been reported in a few patients receiving vincristine sulfate. Several instances of convulsions followed by coma have been reported in pediatric patients. Transient cortical blindness and optic atrophy with blindness have been reported. Treatment with vinca alkaloids has resulted in both vestibular and auditory damage to the eighth cranial nerve. Manifestations include partial or total deafness which may be temporary or permanent, and difficulties with balance including dizziness, nystagmus, and vertigo. Particular caution is warranted when vincristine is used in combination with other agents known to be ototoxic such as the platinum–containing oncolytics. Pulmonary – See PRECAUTIONS section. Acute respiratory distress syndrome has been reported. Endocrine – Rare occurrences of a syndrome attributable to inappropriate antidiuretic hormone secretion have been observed in patients treated with vincristine sulfate. This syndrome is characterized by high urinary sodium excretion in the presence of hyponatremia; renal or adrenal disease, hypotension, dehydration, azotemia, and clinical edema are absent. With fluid deprivation, improvement occurs in the hyponatremia and in the renal loss of sodium. Hematologic – Vincristine Sulfate Injection does not appear to have any constant or significant effect on platelets or red blood cells. Serious bone–marrow depression is usually not a major dose–limiting event. However, anemia, leukopenia, and thrombocytopenia have been reported. Thrombocytopenia, if present when therapy with Vincristine Sulfate Injection is begun, may actually improve before the appearance of bone marrow remission. Granulocytopenia has been reported. Skin – Alopecia and rash have been reported. Other – Fever, headache, dehydration, and hyperuricemia have occurred."],"contraindications":["CONTRAINDICATIONS Patients with the demyelinating form of Charcot–Marie–Tooth syndrome should not be given Vincristine Sulfate Injection. Careful attention should be given to those conditions listed under WARNINGS and PRECAUTIONS ."],"drug_interactions":["Drug Interactions The simultaneous oral or intravenous administration of phenytoin and antineoplastic chemotherapy combinations that included vincristine sulfate has been reported to reduce blood levels of the anticonvulsant and to increase seizure activity. Dosage adjustment should be based on serial blood level monitoring. The contribution of vincristine sulfate to this interaction is not certain. The interaction may result from reduced absorption of phenytoin and an increase in the rate of its metabolism and elimination. Vincristine sulfate is a substrate for cytochrome P450 3A isozymes (CYP3A). Concurrent administration of vincristine sulfate with itraconazole or fluconazole (known inhibitors of the CYP3A metabolic pathway) has been reported to cause an earlier onset and/or an increased severity of neuromuscular side effects (see ADVERSE REACTIONS ). This interaction is presumed to be related to inhibition of the metabolism of vincristine. Therefore, the concomitant use of strong CYP3A inhibitors with vincristine sulfate should be avoided. Patients should be frequently monitored for adverse reactions with concomitant use of moderate CYP3A inhibitors (e.g., fluconazole) with vincristine sulfate. Concurrent use of strong CYP3A inducers (e.g., St. John's Wort) with vincristine sulfate should be avoided. Vincristine sulfate is also a substrate for P-glycoprotein (P-gp). Therefore, the concomitant use of P-gp inhibitors or inducers should be avoided."],"how_supplied_table":["
Unit of SaleTotal Strength/Total Volume(Concentration)
NDC 61703–309–06Carton of 1 single-dose flip-top vial (blue cap)1 mg/mL
NDC 61703–309–16Carton of 1 single-dose flip-top vial (blue cap)2 mg/2 mL(1 mg/mL)
"],"general_precautions":["General Acute uric acid nephropathy, which may occur after the administration of oncolytic agents, has also been reported with vincristine sulfate. In the presence of leukopenia or a complicating infection, administration of the next dose of Vincristine Sulfate Injection warrants careful consideration. Treatment with vincristine sulfate in combination with other chemotherapy agents may cause myelosuppression. Monitor complete blood counts during treatment with vincristine sulfate (see Laboratory Tests below) and provide supportive care, including administration of hematopoietic growth factors, as clinically indicated. If central nervous system leukemia is diagnosed, additional agents may be required, because vincristine does not appear to cross the blood–brain barrier in adequate amounts. Particular attention should be given to dosage and neurologic side effects if Vincristine Sulfate Injection is administered to patients with preexisting neuromuscular disease and when other drugs with neurotoxic potential are also being used. Acute shortness of breath and severe bronchospasm have been reported following the administration of vinca alkaloids. These reactions have been encountered most frequently when the vinca alkaloid was used in combination with mitomycin–C and may require aggressive treatment, particularly when there is preexisting pulmonary dysfunction. The onset of these reactions may occur minutes to several hours after the vinca alkaloid is injected and may occur up to 2 weeks following the dose of mitomycin. Progressive dyspnea requiring chronic therapy may occur. Vincristine sulfate should not be readministered. Care must be taken to avoid contamination of the eye with concentration of Vincristine Sulfate Injection used clinically. If accidental contamination occurs severe irritation (or, if the drug was delivered under pressure, even corneal ulceration) may result. The eye should be washed immediately and thoroughly. The safety of immunization with live vaccines during treatment with vincristine sulfate has not been studied and vaccination with a live virus is not recommended during treatment with vincristine sulfate. Follow current vaccination practice guidelines for administration of live vaccines for patients who have received chemotherapy after completion of treatment with vincristine sulfate."],"storage_and_handling":["This product should be refrigerated between 2°C–8°C (36°F–46°F). Discard unused solution. Protect from light. Store Upright."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY The mechanisms of action of vincristine sulfate remain under investigation. The mechanism of action of vincristine sulfate has been related to the inhibition of microtubule formation in mitotic spindle, resulting in an arrest of dividing cells at the metaphase stage. Central nervous system leukemia has been reported in patients undergoing otherwise successful therapy with vincristine sulfate. This suggests that vincristine does not penetrate well into the cerebrospinal fluid. Pharmacokinetic studies in patients with cancer have shown a triphasic serum decay pattern following rapid intravenous injection. The initial, middle and terminal half–lives are 5 minutes, 2.3 hours, and 85 hours respectively; however, the range of the terminal half–life in humans is from 19 to 155 hours. The liver is the major excretory organ in humans and animals. The metabolism of vinca alkaloids has been shown to be mediated by hepatic cytochrome P450 isoenzymes in the CYP 3A subfamily. This metabolic pathway may be impaired in patients with hepatic dysfunction or who are taking concomitant potent inhibitors of these isoenzymes (see PRECAUTIONS ). About 80% of an injected dose of vincristine sulfate appears in the feces and 10% to 20% can be found in the urine. Within 15 to 30 minutes after injection, over 90% of the drug is distributed from the blood into tissue, where it remains tightly, but not irreversibly, bound. Current principles of cancer chemotherapy involve the simultaneous use of several agents. Generally, each agent used has a unique toxicity and mechanism of action so that therapeutic enhancement occurs without additive toxicity. It is rarely possible to achieve equally good results with single–agent methods of treatment. Thus, vincristine sulfate is often chosen as part of polychemotherapy because of lack of significant bone–marrow suppression (at recommended doses) and of unique clinical toxicity (neuropathy). See DOSAGE AND ADMINISTRATION section for possible increased toxicity when used in combination therapy."],"indications_and_usage":["INDICATIONS AND USAGE Vincristine Sulfate Injection is indicated in acute leukemia. Vincristine Sulfate Injection has also been shown to be useful in combination with other oncolytic agents in Hodgkin's disease, non–Hodgkin's malignant lymphomas, rhabdomyosarcoma, neuroblastoma, and Wilms' tumor."],"spl_unclassified_section":["Rx only PRESERVATIVE FREE SOLUTION Logo","LAB-1307-7.0 Revised: 12/2025 Distributed by Hospira, Inc., Lake Forest, IL 60045 USA and logo"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION This preparation is for intravenous use only (see WARNINGS ). Neurotoxicity appears to be dose related. Extreme care must be used in calculating and administering the dose of Vincristine Sulfate Injection since overdosage may have a very serious or fatal outcome. The usual dose of Vincristine Sulfate Injection for pediatric patients is 1.5–2 mg/m 2 . For pediatric patients weighing 10 kg or less, the starting dose should be 0.05 mg/kg, administered once a week. The usual dose of Vincristine Sulfate Injection for adults is 1.4 mg/m 2 . A 50% reduction in the dose of Vincristine Sulfate Injection is recommended for patients having a direct serum bilirubin value above 3 mg/100 mL. The drug is administered intravenously at weekly intervals. TO REDUCE THE POTENTIAL FOR FATAL MEDICATION ERRORS DUE TO INCORRECT ROUTE OF ADMINISTRATION, VINCRISTINE SULFATE INJECTION SHOULD BE DILUTED IN A FLEXIBLE PLASTIC CONTAINER AND PROMINENTLY LABELED AS INDICATED FOR INTRAVENOUS USE ONLY – FATAL IF GIVEN BY OTHER ROUTES (See WARNINGS ). The concentration of Vincristine Sulfate Injection is 1 mg/mL. Do not add extra fluid to the vial prior to removal of the dose. Withdraw the solution of Vincristine Sulfate Injection into an accurate dry syringe, measuring the dose carefully. Do not add extra fluid to the vial in an attempt to empty it completely. Preparation for flexible plastic container Vincristine Sulfate Injection when diluted with 0.9% Sodium Chloride Injection in concentrations from 0.0015 mg/mL to 0.08 mg/mL is stable for up to 24 hours when protected from light or 8 hours under normal light at 25°C. Caution: It is extremely important that the intravenous needle or catheter be properly positioned before any vincristine is injected. Leakage into surrounding tissue during intravenous administration of Vincristine Sulfate Injection may cause considerable irritation. If extravasation occurs, the injection should be discontinued immediately and any remaining portion of the dose should then be introduced into another vein. Local injection of hyaluronidase and the application of moderate heat to the area of leakage will help disperse the drug and may minimize discomfort and the possibility of cellulitis. Vincristine Sulfate Injection must be administered via an intact, free–flowing intravenous needle or catheter. Care should be taken that there is no leakage or swelling occurring during administration (see boxed WARNINGS ). The diluted Vincristine Sulfate Injection may be infused via a flexible plastic container directly into an intravenous catheter/needle or into a running intravenous infusion (see Drug Interactions below). Patients Receiving Radiation Therapy Vincristine Sulfate Injection should not be given to patients while they are receiving radiation therapy through ports that include the liver. When Vincristine Sulfate Injection is used in combination with L–asparaginase, Vincristine Sulfate Injection should be given 12 to 24 hours before administration of the enzyme in order to minimize toxicity; administering L–asparaginase before Vincristine Sulfate Injection may reduce hepatic clearance of vincristine. Drug Interactions Vincristine Sulfate Injection should not be diluted in solutions that raise or lower the pH outside the range of 3.5 to 5.5. It should not be mixed with anything other than 0.9% Sodium Chloride Injection USP. Whenever solution and container permit, parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Handling and Disposal Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published. 1 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate."],"spl_product_data_elements":["VinCRIStine Sulfate VINCRISTINE SULFATE VINCRISTINE SULFATE VINCRISTINE MANNITOL SULFURIC ACID SODIUM HYDROXIDE WATER"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 1 mL Vial Label 1 mL NDC 61703-309-06 Rx only VinCRIStine Sulfate Injection, USP 1 mg/mL Single-dose Vial For IV Use Only Cytotoxic Agent PRINCIPAL DISPLAY PANEL - 1 mL Vial Label","PRINCIPAL DISPLAY PANEL - 1 mL Vial Carton VIAL Hospira 1 x 1 mL Vial NDC 61703-309-06 Sterile Rx only VinCRIStine Sulfate Injection, USP 1 mg/mL For Intravenous Use Only Fatal If Given By Other Routes Single-dose Vial Caution: Cytotoxic Agent PRINCIPAL DISPLAY PANEL - 1 mL Vial Carton","PRINCIPAL DISPLAY PANEL - 2 mL Vial Label 2 mL NDC 61703-309-16 Rx only VinCRIStine Sulfate Injection, USP 2 mg/2 mL (1 mg/mL) Single-dose Vial For IV Use Only Cytotoxic Agent PRINCIPAL DISPLAY PANEL - 2 mL Vial Label","PRINCIPAL DISPLAY PANEL - 2 mL Vial Carton VIAL Hospira 1 x 2 mL Vial NDC 61703-309-16 Sterile Rx only VinCRIStine Sulfate Injection, USP 2 mg/2 mL (1 mg/mL ) For Intravenous Use Only Fatal If Given By Other Routes Single-dose Vial Caution: Cytotoxic Agent PRINCIPAL DISPLAY PANEL - 2 mL Vial Carton"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility Neither in vivo nor in vitro laboratory tests have conclusively demonstrated the mutagenicity of this product. Fertility following treatment with vincristine sulfate alone for malignant disease has not been studied in humans. Clinical reports of both male and female patients who received multiple–agent chemotherapy that included vincristine sulfate indicate that azoospermia and amenorrhea can occur in postpubertal patients. Recovery occurred many months after completion of chemotherapy in some but not all patients. When the same treatment is administered to prepubertal patients, permanent azoospermia and amenorrhea are much less likely. Patients who received chemotherapy with vincristine sulfate in combination with anti–cancer drugs known to be carcinogenic have developed second malignancies. The contributing role of vincristine sulfate in this development has not been determined. No evidence of carcinogenicity was found following intraperitoneal administration of vincristine sulfate in rats and mice, although this study was limited."]},"tags":[{"label":"Vinca Alkaloid","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Canalicular multispecific organic anion transporter 1","category":"target"},{"label":"ABCC2","category":"gene"},{"label":"ABCB1","category":"gene"},{"label":"ABCC1","category":"gene"},{"label":"L01CA02","category":"atc"},{"label":"Intravenous","category":"route"},{"label":"Injection","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Established","category":"status"},{"label":"Acute lymphoid leukemia","category":"indication"},{"label":"Burkitt's lymphoma","category":"indication"},{"label":"Diffuse non-Hodgkin's lymphoma, large cell","category":"indication"},{"label":"Follicular non-Hodgkin's lymphoma","category":"indication"},{"label":"Hodgkin's disease","category":"indication"},{"label":"Nephroblastoma","category":"indication"},{"label":"Approved 1960s","category":"decade"},{"label":"Antimitotic Agents","category":"pharmacology"},{"label":"Antineoplastic Agents","category":"pharmacology"},{"label":"Antineoplastic Agents, Phytogenic","category":"pharmacology"},{"label":"Tubulin Modulators","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":["WARNINGS Caution–This preparation should be administered by individuals experienced in the administration of Vincristine Sulfate Injection. It is extremely important that the intravenous needle or catheter be properly positioned before any vincristine is injected. Leakage into surrounding tissue during intravenous administration of Vincristine Sulfate Injection may cause considerable irritation. If extravasation occurs, the injection should be discontinued immediately, and any remaining portion of the dose should then be introduced into another vein. Local injection of hyaluronidase and the application of moderate heat to the area of leakage help disperse the drug and are thought to minimize discomfort and the possibility of cellulitis. FOR INTRAVENOUS USE ONLY – FATAL IF GIVEN BY OTHER ROUTES. See OVERDOSAGE section for the treatment of patients given intrathecal Vincristine Sulfate Injection.\nWARNINGS This preparation is for intravenous use only. It should be administered by individuals experienced in the administration of Vincristine Sulfate Injection. The intrathecal administration of Vincristine Sulfate Injection usually results in death. To reduce the potential for fatal medication errors due to incorrect route of administration, Vincristine Sulfate Injection should be diluted in a flexible plastic container and prominently labeled as indicated \"FOR INTRAVENOUS USE ONLY – FATAL IF GIVEN BY OTHER ROUTES.\" See OVERDOSAGE section for the treatment of patients given intrathecal Vincristine Sulfate Injection."],"safetySignals":[{"date":"","signal":"FEBRILE NEUTROPENIA","source":"FDA FAERS","actionTaken":"4247 reports"},{"date":"","signal":"PYREXIA","source":"FDA FAERS","actionTaken":"1858 reports"},{"date":"","signal":"NEUTROPENIA","source":"FDA FAERS","actionTaken":"1705 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"1670 reports"},{"date":"","signal":"SEPSIS","source":"FDA FAERS","actionTaken":"1076 reports"},{"date":"","signal":"VOMITING","source":"FDA FAERS","actionTaken":"1003 reports"},{"date":"","signal":"DISEASE PROGRESSION","source":"FDA FAERS","actionTaken":"997 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"930 reports"},{"date":"","signal":"PANCYTOPENIA","source":"FDA FAERS","actionTaken":"912 reports"},{"date":"","signal":"PNEUMONIA","source":"FDA FAERS","actionTaken":"905 reports"}],"drugInteractions":[{"drug":"Phenytoin","severity":"major","mechanism":"Reduced absorption of phenytoin and increased rate of its metabolism and elimination","management":"Dosage adjustment should be based on serial blood level monitoring","clinicalEffect":"Reduction in blood levels of phenytoin and increased seizure activity"},{"drug":"Itraconazole","severity":"major","mechanism":"Inhibition of CYP3A metabolic pathway","management":"Concomitant use should be avoided; if used, patients should be frequently monitored for adverse reactions","clinicalEffect":"Earlier onset and/or increased severity of neuromuscular side effects"},{"drug":"Fluconazole","severity":"moderate","mechanism":"Inhibition of CYP3A metabolic pathway","management":"Patients should be frequently monitored for adverse reactions","clinicalEffect":"Earlier onset and/or increased severity of neuromuscular side effects"},{"drug":"St. John's Wort","severity":"major","mechanism":"Induction of CYP3A metabolic pathway","management":"Concomitant use should be avoided","clinicalEffect":"Not explicitly stated, but likely reduction in vincristine sulfate efficacy"},{"drug":"P-glycoprotein (P-gp) inhibitors or inducers","severity":"major","mechanism":"Inhibition or induction of P-gp","management":"Concomitant use should be avoided","clinicalEffect":"Not explicitly stated, but likely alteration in vincristine sulfate efficacy or toxicity"}],"commonSideEffects":[{"effect":"Febrile neutropenia","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Disease progression","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Febrile bone marrow aplasia","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Diffuse large B-cell lymphoma recurrent","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Haematotoxicity","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Mucosal inflammation","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Second primary malignancy","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Sepsis","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Pancytopenia","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Thrombocytopenia","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Acute myeloid leukaemia","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Hepatitis B reactivation","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Myelosuppression","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3}],"contraindications":["Patients with the demyelinating form of Charcot–Marie–Tooth syndrome should not be given Vincristine Sulfate Injection."],"specialPopulations":{"Pregnancy":"See WARNINGS.","Paediatric use":"See DOSAGE AND ADMINISTRATION section."}},"trials":[],"aliases":[],"patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=Vincristine Sulfate","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:31:50.995171+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Vincristine Sulfate","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-19T23:31:58.884968+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-19T23:33:03.888068+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:31:57.019369+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-19T23:31:50.116977+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=Vincristine Sulfate","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:31:57.367655+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:31:47.683865+00:00"},"indications.approved":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:32:57.497006+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (boxed_warning)","rawText":"WARNINGS Caution–This preparation should be administered by individuals experienced in the administration of Vincristine Sulfate Injection. It is extremely important that the intravenous needle or catheter be properly positioned before any vincristine is injected. Leakage into surrounding tissue during intravenous administration of Vincristine Sulfate Injection may cause considerable irritation. If extravasation occurs, the injection should be discontinued immediately, and any remaining portion ","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:31:47.683901+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-19T23:31:59.352979+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Tubulin inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:31:58.884907+00:00"},"safety.drugInteractions":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:32:31.258901+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL501867/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:31:58.528578+00:00"},"safety.commonSideEffects":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"ADVERSE REACTIONS Prior to the use of this drug, patients and/or their parents/guardian should be advised of the possibility of untoward symptoms. In general, adverse reactions are reversible and are related to dosage. The most common adverse reaction is hair loss; the most troublesome adverse reactions are neuromuscular in origin. When single, weekly doses of the drug are employed, the adverse reactions of leukopenia, neuritic pain, and constipation occur but are usually of short duration (ie.,","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:32:02.899754+00:00"},"safety.contraindications":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:32:09.935527+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA071484","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:31:47.683907+00:00"}},"allNames":"oncovin","offLabel":[],"synonyms":["vincristine","(+)-Vincristine","leucristine","vincristin","vinkristin","22-oxo-vincaleukoblastine","vincristine sulfate","oncovin"],"timeline":[{"date":"1963-07-10","type":"positive","source":"DrugCentral","milestone":"FDA approval"},{"date":"1988-04-11","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 4 manufacturers approved"},{"date":"2012-08-09","type":"positive","source":"FDA Orange Book","milestone":"Marqibo Kit approved — 5MG/5ML (1MG/ML)"}],"aiSummary":"Vincristine Sulfate (Oncovin), marketed by Pfizer Inc., is a well-established chemotherapy agent primarily indicated for acute leukemia, with a key composition patent expiring in 2028. Its mechanism of action, which disrupts cell division by binding to tubulin, provides a strong therapeutic profile against its primary indication. The primary risk is the competition from off-patent generics of same-class drugs such as vinblastine and vinorelbine, which may erode market share.","brandName":"Oncovin","ecosystem":[{"indication":"Acute lymphoid leukemia","otherDrugs":[{"name":"asparaginase","slug":"asparaginase","company":"Merck"},{"name":"betamethasone","slug":"betamethasone","company":""},{"name":"betamethasone acetate","slug":"betamethasone-acetate","company":""},{"name":"clofarabine","slug":"clofarabine","company":"Genzyme"}],"globalPrevalence":453000},{"indication":"Burkitt's lymphoma","otherDrugs":[{"name":"cyclophosphamide","slug":"cyclophosphamide","company":"Baxter Hlthcare"},{"name":"dexamethasone","slug":"dexamethasone","company":""},{"name":"doxorubicin","slug":"doxorubicin","company":""},{"name":"methotrexate","slug":"methotrexate","company":"Dava Pharms Inc"}],"globalPrevalence":null},{"indication":"Diffuse non-Hodgkin's lymphoma, large cell","otherDrugs":[{"name":"bleomycin","slug":"bleomycin","company":"Bristol Myers Squibb"},{"name":"carmustine","slug":"carmustine","company":"Emcure Pharms Ltd"},{"name":"dexamethasone","slug":"dexamethasone","company":""},{"name":"doxorubicin","slug":"doxorubicin","company":""}],"globalPrevalence":123507000},{"indication":"Follicular non-Hodgkin's lymphoma","otherDrugs":[{"name":"bendamustine","slug":"bendamustine","company":"Cephalon"},{"name":"betamethasone","slug":"betamethasone","company":""},{"name":"bleomycin","slug":"bleomycin","company":"Bristol Myers Squibb"},{"name":"chlorambucil","slug":"chlorambucil","company":"Aspen Global Inc"}],"globalPrevalence":123507000},{"indication":"Hodgkin's disease","otherDrugs":[{"name":"betamethasone","slug":"betamethasone","company":""},{"name":"betamethasone acetate","slug":"betamethasone-acetate","company":""},{"name":"bleomycin","slug":"bleomycin","company":"Bristol Myers Squibb"},{"name":"brentuximab vedotin","slug":"brentuximab-vedotin","company":"Seattle Genetics"}],"globalPrevalence":null},{"indication":"Nephroblastoma","otherDrugs":[{"name":"dactinomycin","slug":"dactinomycin","company":"Recordati Rare"},{"name":"doxorubicin","slug":"doxorubicin","company":""}],"globalPrevalence":null},{"indication":"Neuroblastoma","otherDrugs":[{"name":"busulfan","slug":"busulfan","company":"Aspen Global"},{"name":"cyclophosphamide","slug":"cyclophosphamide","company":"Baxter Hlthcare"},{"name":"dinutuximab","slug":"dinutuximab","company":"United Therap"},{"name":"doxorubicin","slug":"doxorubicin","company":""}],"globalPrevalence":880000},{"indication":"Non-Hodgkin's lymphoma","otherDrugs":[{"name":"betamethasone","slug":"betamethasone","company":""},{"name":"betamethasone acetate","slug":"betamethasone-acetate","company":""},{"name":"bleomycin","slug":"bleomycin","company":"Bristol Myers Squibb"},{"name":"carmustine","slug":"carmustine","company":"Emcure Pharms Ltd"}],"globalPrevalence":123507000}],"mechanism":{"target":"Canalicular multispecific organic anion transporter 1","novelty":"First-in-class","targets":[{"gene":"ABCC2","source":"DrugCentral","target":"Canalicular multispecific organic anion transporter 1","protein":"Canalicular multispecific organic anion transporter 1"},{"gene":"ABCB1","source":"DrugCentral","target":"Multidrug resistance protein 1","protein":"Multidrug resistance protein 1"},{"gene":"ABCC1","source":"DrugCentral","target":"Multidrug resistance-associated protein 1","protein":"Multidrug resistance-associated protein 1"},{"gene":"ABCC10","source":"DrugCentral","target":"Multidrug resistance-associated protein 7","protein":"Multidrug resistance-associated protein 7"},{"gene":"TUBB","source":"DrugCentral","target":"Tubulin beta","protein":"Tubulin beta chain"},{"gene":"TUBB1","source":"DrugCentral","target":"Tubulin beta","protein":"Tubulin beta-1 chain"},{"gene":"TUBB2A","source":"DrugCentral","target":"Tubulin beta","protein":"Tubulin beta-2A chain"},{"gene":"TUBB2B","source":"DrugCentral","target":"Tubulin beta","protein":"Tubulin beta-2B chain"},{"gene":"TUBB3","source":"DrugCentral","target":"Tubulin beta","protein":"Tubulin beta-3 chain"},{"gene":"TUBB4A","source":"DrugCentral","target":"Tubulin beta","protein":"Tubulin beta-4A chain"}],"modality":"Small Molecule","drugClass":"Vinca Alkaloid","explanation":"","oneSentence":"","technicalDetail":"Oncovin binds to tubulin, a protein component of microtubules, and inhibits microtubule polymerization, thereby disrupting the mitotic spindle and arresting cell division in the metaphase."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Vincristine","title":"Vincristine","extract":"Vincristine, also known as leurocristine and sold under the brand name Oncovin among others, is a chemotherapy medication used to treat a number of types of cancer. This includes acute lymphocytic leukemia, acute myeloid leukemia, Hodgkin lymphoma, neuroblastoma, and small cell lung cancer among others. It is given intravenously.","wiki_history":"==History==\nHaving been used as a folk remedy for centuries, studies in the 1950s revealed that the rosy periwinkle Catharanthus roseus contained over 120 alkaloids, many of which are biologically active, the two most significant being vincristine and vinblastine. Its use as an anti-tumor, anti-mutagenic agent is well documented in the ancient Ayurveda system of medicine and in the folk culture of Madagascar and Southern Africa. It was not found to be anti-diabetic in double blinded controlled studies. While initial studies for its use in diabetes mellitus were disappointing, the discovery that it caused myelosuppression (decreased activity of the bone marrow) led to its study in mice with leukemia, whose lifespan was prolonged by the use of a vinca preparation. Treatment of the ground plant with Skellysolve-B (hexane), followed by dilute tartaric acid and benzene extraction, provided an active fraction. This fraction was further chromatographed on deactivated aluminium oxide using trichloromethane and benzene, and separation by pH using extraction with various buffers to yield vincristine.\n\nVincristine was approved by the US Food and Drug Administration (FDA) in July 1963 under the brand name Oncovin and was marketed by Eli Lilly and Company. The drug was initially developed by a team at Lilly Research Laboratories in Indianapolis where it was demonstrated that vincristine cured artificially induced leukemia in mice and remission of acute leukemias of childhood.\n\nProduction of vincristine required one ton of dried periwinkle leaves to produce one ounce of vincristine. The periwinkle was grown on a ranch in Texas.","wiki_society_and_culture":"==Society and culture==\n\n=== Suppliers ===\nTwo generic drug makers were suppliers of vincristine in the United States: Teva and Pfizer. In 2019 Teva stopped producing vincristine, leaving Pfizer as the only company in production. Teva has said that they will restart production, and expect it to be available in 2020.\n\n=== Shortage ===\nIn October 2019 an impending shortage was reported; no adequate substitute is known for treating childhood cancers. By 2022, the shortage of vincristine continued.\n\n===Controversy===\n\n====Pharmaceutical bioprospecting====\n\nVincristine's origins are debated as an example of pharmaceutical bioprospecting in the fields of ethnobotany and ethnomedicine. Some consider the Catharanthus roseus plant from which vincristine is derived, and its folk remedies to be endemic to Madagascar, and that Madagascar was denied royalties from vincristine sales. However, Catharanthus roseus has a documented history in folk medicine treatments in other locations. In 1963, Lilly researchers acknowledged that the plant was used in Brazil to treat hemorrhage, scurvy, toothaches, and chronic wounds; in the British West Indies to treat diabetic ulcers; and in the Philippines and South Africa as an oral hypoglycemic agent – but not as a treatment for cancer.\n\nCatharanthus roseus has been a cosmopolitan species since before the Industrial Revolution and the plant's use in folk remedies suggested general bioactivity for diabetes treatment, not cancer. In the mid-eighteenth century, botanist Judith Sumner recorded the arrival of Catharanthus roseus at London's Chelsea Physic Garden from the Jardin des plantes in Paris. It's unclear how the plant first arrived in Paris and the details of its origins in Madagascar beyond reports of its transport from Madagascar by early European explorers. Vincristine was initially distributed at cost to increase accessibility, though later switched to a for-profit model to recover the costs of production and development. According to M"},"commercial":{"launchDate":"1963","_launchSource":"DrugCentral (FDA 1963-07-10, )"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/2825","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=Vincristine%20Sulfate","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=Vincristine Sulfate","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Vincristine","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T02:04:23.288580","_validation":{"fieldsValidated":3,"lastValidatedAt":"2026-04-19T23:33:03.888571+00:00","fieldsConflicting":14,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"vinblastine","drugSlug":"vinblastine","fdaApproval":"1965-11-05","genericCount":4,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"vinorelbine","drugSlug":"vinorelbine","fdaApproval":"1994-12-23","genericCount":10,"patentStatus":"Off-patent — generic available","relationship":"same-class"}],"genericName":"vincristine sulfate","indications":{"approved":[{"id":"vincristine-sulfate-pfs-acute-leukemia","name":"Acute leukemia","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Patients with acute leukemia","pivotalTrial":null,"restrictions":[],"patientPopulation":"Patients with acute leukemia","diagnosticRequired":null,"brandNameForIndication":"Oncovin"},{"id":"vincristine-sulfate-pfs-hodgkin's-disease","name":"Hodgkin's disease","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Patients with Hodgkin's disease","pivotalTrial":null,"restrictions":[],"patientPopulation":"Patients with Hodgkin's disease","diagnosticRequired":null,"brandNameForIndication":"Oncovin"},{"id":"vincristine-sulfate-pfs-non-hodgkin's-malignant-lympho","name":"Non-Hodgkin's malignant lymphomas","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Patients with non-Hodgkin's malignant lymphomas","pivotalTrial":null,"restrictions":[],"patientPopulation":"Patients with non-Hodgkin's malignant lymphomas","diagnosticRequired":null,"brandNameForIndication":"Oncovin"},{"id":"vincristine-sulfate-pfs-rhabdomyosarcoma","name":"Rhabdomyosarcoma","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Patients with rhabdomyosarcoma","pivotalTrial":null,"restrictions":[],"patientPopulation":"Patients with rhabdomyosarcoma","diagnosticRequired":null,"brandNameForIndication":"Oncovin"},{"id":"vincristine-sulfate-pfs-neuroblastoma","name":"Neuroblastoma","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Patients with neuroblastoma","pivotalTrial":null,"restrictions":[],"patientPopulation":"Patients with neuroblastoma","diagnosticRequired":null,"brandNameForIndication":"Oncovin"},{"id":"vincristine-sulfate-pfs-wilms'-tumor","name":"Wilms' tumor","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Patients with Wilms' tumor","pivotalTrial":null,"restrictions":[],"patientPopulation":"Patients with Wilms' tumor","diagnosticRequired":null,"brandNameForIndication":"Oncovin"}],"offLabel":[{"name":"Astrocytoma, anaplastic","source":"DrugCentral","drugName":"Vincristine Sulfate","evidenceCount":459,"evidenceLevel":"strong"},{"name":"Chronic lymphoid leukemia, disease","source":"DrugCentral","drugName":"Vincristine Sulfate","evidenceCount":404,"evidenceLevel":"strong"},{"name":"Ewing's sarcoma","source":"DrugCentral","drugName":"Vincristine Sulfate","evidenceCount":629,"evidenceLevel":"strong"},{"name":"Glioblastoma multiforme of brain","source":"DrugCentral","drugName":"Vincristine Sulfate","evidenceCount":248,"evidenceLevel":"strong"},{"name":"Multiple myeloma","source":"DrugCentral","drugName":"Vincristine Sulfate","evidenceCount":1233,"evidenceLevel":"strong"},{"name":"Mycosis fungoides","source":"DrugCentral","drugName":"Vincristine Sulfate","evidenceCount":91,"evidenceLevel":"strong"},{"name":"Ovarian Germ Cell Tumor Carcinoma","source":"DrugCentral","drugName":"Vincristine Sulfate","evidenceCount":50,"evidenceLevel":"moderate"},{"name":"Primary cutaneous T-cell lymphoma","source":"DrugCentral","drugName":"Vincristine Sulfate","evidenceCount":285,"evidenceLevel":"strong"},{"name":"Small cell carcinoma of lung","source":"DrugCentral","drugName":"Vincristine Sulfate","evidenceCount":1020,"evidenceLevel":"strong"}],"pipeline":[]},"currentOwner":"Lilly","drugCategory":"established","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"vinblastine","brandName":"vinblastine","genericName":"vinblastine","approvalYear":"1965","relationship":"same-class"},{"drugId":"vinorelbine","brandName":"vinorelbine","genericName":"vinorelbine","approvalYear":"1994","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT04759586","phase":"PHASE3","title":"Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2021-10-05","conditions":["Primary Mediastinal Large B-Cell Lymphoma"],"enrollment":244,"completionDate":"2026-12-31"},{"nctId":"NCT02306161","phase":"PHASE3","title":"Combination Chemotherapy With or Without Ganitumab in Treating Patients With Newly Diagnosed Metastatic Ewing Sarcoma","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2014-12-12","conditions":["Metastatic Ewing Sarcoma","Metastatic Malignant Neoplasm in the Bone","Metastatic Malignant Neoplasm in the Bone Marrow","Metastatic Malignant Neoplasm in the Lung","Metastatic Peripheral Primitive Neuroectodermal Tumor of Bone","Peripheral Primitive Neuroectodermal Tumor of Soft Tissues"],"enrollment":312,"completionDate":"2026-09-17"},{"nctId":"NCT06317662","phase":"PHASE2","title":"Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia","status":"RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2025-06-05","conditions":["Acute Leukemia of Ambiguous Lineage","B Acute Lymphoblastic Leukemia"],"enrollment":153,"completionDate":"2028-12-31"},{"nctId":"NCT04166409","phase":"PHASE3","title":"A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma","status":"RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2020-01-31","conditions":["Low Grade Astrocytoma","Low Grade Glioma","Metastatic Low Grade Astrocytoma","Metastatic Low Grade Glioma","WHO Grade 1 Glioma","WHO Grade 2 Glioma"],"enrollment":170,"completionDate":"2030-12-31"},{"nctId":"NCT03914625","phase":"PHASE3","title":"A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2019-07-03","conditions":["B Acute Lymphoblastic Leukemia","B Lymphoblastic Lymphoma","Down Syndrome"],"enrollment":6720,"completionDate":"2027-09-30"},{"nctId":"NCT00092222","phase":"PHASE2","title":"Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2004-10-28","conditions":["Lymphoproliferative Disorder","HHV-8","Malignancy","HIV"],"enrollment":75,"completionDate":"2026-10-01"},{"nctId":"NCT06172296","phase":"PHASE3","title":"Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma","status":"RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2024-04-19","conditions":["Ganglioneuroblastoma, Nodular","Neuroblastoma"],"enrollment":478,"completionDate":"2029-12-31"},{"nctId":"NCT07495631","phase":"NA","title":"Pediatric-Inspired Regimen Combined With Venetoclax and Immunotherapy for Adult Ph-Negative Acute Lymphoblastic Leukemia","status":"NOT_YET_RECRUITING","sponsor":"Institute of Hematology & Blood Diseases Hospital, China","startDate":"2026-03-01","conditions":["Acute Lymphoblastic Leukemia, Adult"],"enrollment":80,"completionDate":"2030-03-01"},{"nctId":"NCT02567435","phase":"PHASE3","title":"Combination Chemotherapy With or Without Temsirolimus in Treating Patients With Intermediate Risk Rhabdomyosarcoma","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2016-06-01","conditions":["Alveolar Rhabdomyosarcoma","Botryoid-Type Embryonal Rhabdomyosarcoma","Embryonal Rhabdomyosarcoma","Rhabdomyosarcoma","Sclerosing Rhabdomyosarcoma","Spindle Cell Rhabdomyosarcoma"],"enrollment":325,"completionDate":"2026-10-27"},{"nctId":"NCT04301076","phase":"PHASE1","title":"Testing the Addition of an Anti-cancer Drug, Lenalidomide, to the Usual Combination Chemotherapy Treatment (\"EPOCH\") for Adult T-Cell Leukemia-Lymphoma (ATLL)","status":"SUSPENDED","sponsor":"National Cancer Institute (NCI)","startDate":"2021-08-31","conditions":["Acute Adult T-Cell Leukemia/Lymphoma","Adult T-Cell Leukemia/Lymphoma","Chronic Adult T-Cell Leukemia/Lymphoma","HTLV-1 Infection"],"enrollment":30,"completionDate":"2027-06-30"},{"nctId":"NCT00980460","phase":"PHASE3","title":"Risk-Based Therapy in Treating Younger Patients With Newly Diagnosed Liver Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2009-09-14","conditions":["PRETEXT I Hepatoblastoma","PRETEXT II Hepatoblastoma","PRETEXT III Hepatoblastoma","PRETEXT IV Hepatoblastoma"],"enrollment":236,"completionDate":"2026-03-19"},{"nctId":"NCT02166463","phase":"PHASE3","title":"Brentuximab Vedotin and Combination Chemotherapy in Treating Children and Young Adults With Stage IIB, Stage IIIB, IVA, or IVB Hodgkin Lymphoma","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2015-03-19","conditions":["Ann Arbor Stage IIB Hodgkin Lymphoma","Ann Arbor Stage IIIB Hodgkin Lymphoma","Ann Arbor Stage IVA Hodgkin Lymphoma","Ann Arbor Stage IVB Hodgkin Lymphoma","Childhood Hodgkin Lymphoma","Classic Hodgkin Lymphoma"],"enrollment":600,"completionDate":"2026-10-03"},{"nctId":"NCT07494565","phase":"PHASE2","title":"Celecoxib Plus R-CHOP vs R-CHOP in Newly Diagnosed Advanced CD5+ DLBCL","status":"NOT_YET_RECRUITING","sponsor":"Sun Yat-sen University","startDate":"2026-03-05","conditions":["Diffuse Large B-Cell Lymphoma (DLBCL)","CD5 Positive"],"enrollment":60,"completionDate":"2028-12-31"},{"nctId":"NCT00428142","phase":"PHASE2","title":"Bortezomib, Combination Chemotherapy, and Rituximab as First-Line Therapy in Treating Patients With Stage III or Stage IV Follicular Non-Hodgkin's Lymphoma","status":"COMPLETED","sponsor":"NCIC Clinical Trials Group","startDate":"2007-05-01","conditions":["Lymphoma"],"enrollment":95,"completionDate":"2012-01-06"},{"nctId":"NCT04307576","phase":"PHASE3","title":"A Treatment Study Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia","status":"RECRUITING","sponsor":"Mats Heyman","startDate":"2020-07-13","conditions":["Leukemia, Acute Lymphoblastic"],"enrollment":6430,"completionDate":"2033-06"},{"nctId":"NCT00792948","phase":"PHASE2","title":"Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2009-09-01","conditions":["Acute Lymphoblastic Leukemia","Adult B Acute Lymphoblastic Leukemia","Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1","Adult L1 Acute Lymphoblastic Leukemia","Adult L2 Acute Lymphoblastic Leukemia","Adult T Acute Lymphoblastic Leukemia","Recurrent Adult Acute Lymphoblastic Leukemia"],"enrollment":97,"completionDate":"2027-01-06"},{"nctId":"NCT03269669","phase":"PHASE2","title":"Obinutuzumab With or Without Umbralisib, Lenalidomide, or Combination Chemotherapy in Treating Patients With Relapsed or Refractory Grade I-IIIa Follicular Lymphoma","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2018-01-23","conditions":["Grade 1 Follicular Lymphoma","Grade 2 Follicular Lymphoma","Grade 3a Follicular Lymphoma","Recurrent Follicular Lymphoma","Refractory Follicular Lymphoma"],"enrollment":73,"completionDate":"2027-01-21"},{"nctId":"NCT03984448","phase":"PHASE2,PHASE3","title":"Testing the Addition of a New Anti-cancer Drug, Venetoclax, to Usual Chemotherapy for High Grade B-cell Lymphomas","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2019-10-22","conditions":["Diffuse Large B-Cell Lymphoma","Diffuse Large B-Cell Lymphoma, Not Otherwise Specified","Double-Expressor Lymphoma","EBV-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise Specified","High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements","High Grade B-Cell Lymphoma, Not Otherwise Specified","Neoplastic Cells With Double Expression of MYC and BCL2 Proteins Present","Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma"],"enrollment":363,"completionDate":"2028-04-01"},{"nctId":"NCT04530565","phase":"PHASE3","title":"Testing the Use of Steroids and Tyrosine Kinase Inhibitors With Blinatumomab or Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults","status":"RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2021-01-25","conditions":["B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1"],"enrollment":348,"completionDate":"2028-07-01"},{"nctId":"NCT05675410","phase":"PHASE3","title":"A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab","status":"RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2023-05-11","conditions":["Lugano Classification Limited Stage Hodgkin Lymphoma AJCC v8"],"enrollment":1875,"completionDate":"2031-04-28"},{"nctId":"NCT01856192","phase":"PHASE2","title":"Rituximab and Combination Chemotherapy With or Without Lenalidomide in Treating Patients With Newly Diagnosed Stage II-IV Diffuse Large B Cell Lymphoma","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2013-08-27","conditions":["Ann Arbor Stage II Diffuse Large B-Cell Lymphoma","Ann Arbor Stage III Diffuse Large B-Cell Lymphoma","Ann Arbor Stage IV Diffuse Large B-Cell Lymphoma"],"enrollment":349,"completionDate":"2026-12-31"},{"nctId":"NCT06717347","phase":"PHASE3","title":"A Study to Evaluate Zilovertamab Vedotin (MK-2140) Combination With Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Previously Untreated DLBCL (MK-2140-010)","status":"RECRUITING","sponsor":"Merck Sharp & Dohme LLC","startDate":"2025-01-27","conditions":["Diffuse Large B-Cell Lymphoma"],"enrollment":1046,"completionDate":"2032-03-29"},{"nctId":"NCT07444710","phase":"PHASE1","title":"Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) for Previously Untreated Mantle Cell Lymphoma","status":"NOT_YET_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2026-08-20","conditions":["Ann Arbor Stage II Mantle Cell Lymphoma","Ann Arbor Stage III Mantle Cell Lymphoma","Ann Arbor Stage IV Mantle Cell Lymphoma"],"enrollment":16,"completionDate":"2027-09-01"},{"nctId":"NCT02143414","phase":"PHASE2","title":"Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Acute Lymphoblastic Leukemia","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2015-06-30","conditions":["Acute Lymphoblastic Leukemia","B Acute Lymphoblastic Leukemia","B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1","Recurrent Acute Lymphoblastic Leukemia","Refractory Acute Lymphoblastic Leukemia"],"enrollment":53,"completionDate":"2027-01-26"},{"nctId":"NCT03871257","phase":"PHASE3","title":"A Study of the Drugs Selumetinib Versus Carboplatin/Vincristine in Patients With Neurofibromatosis and Low-Grade Glioma","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2020-01-15","conditions":["Low Grade Glioma","Neurofibromatosis Type 1","Visual Pathway Glioma"],"enrollment":165,"completionDate":"2027-12-31"},{"nctId":"NCT07496229","phase":"PHASE1,PHASE2","title":"Assessing Treatment of T-Cell Lymphoma With GW5282 in Combination With Golidocitinib (BEI-DOU3)","status":"NOT_YET_RECRUITING","sponsor":"Dizal Pharmaceuticals","startDate":"2026-03","conditions":["T-cell Lymphomas"],"enrollment":165,"completionDate":"2029-12"},{"nctId":"NCT07493161","phase":"NA","title":"Chemotherapy With Targeted-Immunotherapy for Newly Diagnosed Ph+ ALL","status":"NOT_YET_RECRUITING","sponsor":"Institute of Hematology & Blood Diseases Hospital, China","startDate":"2026-04-01","conditions":["Ph+ ALL"],"enrollment":100,"completionDate":"2030-03-30"},{"nctId":"NCT07493148","phase":"PHASE2","title":"Chidamide Combination With R-mini CHOP Followed by Chidamide+CD20 Maintenance in Elderly Newly Diagnosed MYC/BCL2+ DLBCL","status":"RECRUITING","sponsor":"Ou Bai, MD/PHD","startDate":"2026-04-30","conditions":["Diffuse Large B-Cell Lymphoma (DLBCL)"],"enrollment":50,"completionDate":"2029-12-30"},{"nctId":"NCT05888493","phase":"PHASE3","title":"A Phase III Trial Comparing Tisagenlecleucel to Standard of Care (SoC) in Adult Participants With r/r Follicular Lymphoma","status":"ACTIVE_NOT_RECRUITING","sponsor":"Novartis Pharmaceuticals","startDate":"2023-10-02","conditions":["Follicular Lymphoma (FL)"],"enrollment":109,"completionDate":"2031-02-20"},{"nctId":"NCT07224100","phase":"PHASE2","title":"Dose-Adjusted EPOCH With or Without Rituximab Plus Ponatinib for the Treatment of Newly-Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia/Lymphoma","status":"RECRUITING","sponsor":"University of Washington","startDate":"2026-04-15","conditions":["B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1","B Lymphoblastic Leukemia/Lymphoma With t(9;22)(q34.1;q11.2); BCR-ABL1","Lymphoblastic Lymphoma"],"enrollment":33,"completionDate":"2028-07-31"},{"nctId":"NCT04799275","phase":"PHASE2,PHASE3","title":"Testing CC-486 (Oral Azacitidine) Plus the Standard Drug Therapy in Patients 75 Years or Older With Newly Diagnosed Diffuse Large B Cell Lymphoma","status":"SUSPENDED","sponsor":"National Cancer Institute (NCI)","startDate":"2021-05-20","conditions":["Ann Arbor Stage III Diffuse Large B-Cell Lymphoma","Ann Arbor Stage IIX (Bulky) Diffuse Large B-Cell Lymphoma","Ann Arbor Stage IV Diffuse Large B-Cell Lymphoma","Diffuse Large B-Cell Lymphoma Activated B-Cell Type","Diffuse Large B-Cell Lymphoma Associated With Chronic Inflammation","Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type","Diffuse Large B-Cell Lymphoma, Not Otherwise Specified","EBV-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise Specified","Grade 3b Follicular Lymphoma","HHV8-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise Specified","High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements","High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements","High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements","High Grade B-Cell Lymphoma, Not Otherwise Specified","Intravascular Large B-Cell Lymphoma","Lymphoplasmacytic Lymphoma","Nodular Lymphocyte Predominant B-Cell Lymphoma","Primary Cutaneous Diffuse Large B-Cell Lymphoma, Leg Type","T-Cell/Histiocyte-Rich Large B-Cell Lymphoma","Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma","Transformed Marginal Zone Lymphoma to Diffuse Large B-Cell Lymphoma"],"enrollment":422,"completionDate":"2027-03-01"},{"nctId":"NCT07215585","phase":"PHASE3","title":"AZD0486 1L Therapy for Elderly or Unfit Participants With LBCL","status":"RECRUITING","sponsor":"AstraZeneca","startDate":"2025-11-11","conditions":["Large B-cell Lymphoma"],"enrollment":420,"completionDate":"2033-07-28"},{"nctId":"NCT05748171","phase":"PHASE2","title":"A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin (InO) in Children (1 to <18 Years) With First Relapse ALL","status":"RECRUITING","sponsor":"Pfizer","startDate":"2023-05-17","conditions":["ACUTE LYMPHOBLASTIC LEUKEMIA"],"enrollment":100,"completionDate":"2036-11-04"},{"nctId":"NCT02405676","phase":"PHASE2,PHASE3","title":"BNHL-2015 for Children or Adolescents in China","status":"ACTIVE_NOT_RECRUITING","sponsor":"Children's Cancer Group, China","startDate":"2015-01-01","conditions":["Mature B-cell Non-Hodgkin Lymphoma"],"enrollment":200,"completionDate":"2029-12"},{"nctId":"NCT05681260","phase":"PHASE3","title":"Capizzi Escalating Methotrexate Versus High Dose Methotrexate in Children With Newly Diagnosed T-cell Lymphoblastic Lymphoma (T-LBL)","status":"RECRUITING","sponsor":"Children's Cancer Group, China","startDate":"2023-02-06","conditions":["T-cell Lymphoblastic Lymphoma"],"enrollment":200,"completionDate":"2029-12-31"},{"nctId":"NCT07480863","phase":"PHASE2","title":"Treatment of BTKi+Hi-CVP Regimen for Previously Untreated MZL","status":"ACTIVE_NOT_RECRUITING","sponsor":"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","startDate":"2025-10-01","conditions":["Marginal Zone Lymphoma(MZL)"],"enrollment":65,"completionDate":"2029-10-02"},{"nctId":"NCT03684980","phase":"EARLY_PHASE1","title":"LTA Pilot Study of Glucarpidase in Patients With Central Nervous System Lymphoma","status":"ACTIVE_NOT_RECRUITING","sponsor":"Memorial Sloan Kettering Cancer Center","startDate":"2018-11-14","conditions":["Central Nervous System Lymphoma"],"enrollment":58,"completionDate":"2027-11"},{"nctId":"NCT06549595","phase":"PHASE3","title":"A Study of Surovatamig (AZD0486) Plus Rituximab in Previously Untreated Follicular Lymphoma Patients","status":"RECRUITING","sponsor":"AstraZeneca","startDate":"2024-08-07","conditions":["Untreated Follicular Lymphoma"],"enrollment":1018,"completionDate":"2031-11-26"},{"nctId":"NCT06313996","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of Liso-cel Compared to Standard of Care in Adults With Relapsed or Refractory Follicular Lymphoma","status":"WITHDRAWN","sponsor":"Juno Therapeutics, Inc., a Bristol-Myers Squibb Company","startDate":"2024-03-29","conditions":["Relapsed or Refractory Follicular Lymphoma"],"enrollment":0,"completionDate":"2031-10-16"},{"nctId":"NCT05384821","phase":"PHASE1,PHASE2","title":"Metronomic Chemotherapy in Wilms Tumor (MetroWilms-1906)","status":"RECRUITING","sponsor":"Centre Oscar Lambret","startDate":"2022-09-14","conditions":["Wilms Tumor"],"enrollment":28,"completionDate":"2028-10"},{"nctId":"NCT02845882","phase":"PHASE3","title":"LBL-2016 for Children or Adolescents in China","status":"ACTIVE_NOT_RECRUITING","sponsor":"Children's Cancer Group, China","startDate":"2016-01","conditions":["Lymphoblastic Lymphoma"],"enrollment":150,"completionDate":"2031-12"},{"nctId":"NCT06207123","phase":"PHASE1,PHASE2","title":"A Study to Investigate LP-118, Ponatinib, Vincristine and Dexamethasone in Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LBL)","status":"RECRUITING","sponsor":"University of Chicago","startDate":"2024-09-13","conditions":["Acute Leukemia","Lymphoblastic Leukemia","Lymphoblastic Lymphoma"],"enrollment":15,"completionDate":"2026-12-01"},{"nctId":"NCT06918431","phase":"PHASE2","title":"Asparaginase Erwinia Chrysanthemi With Chemotherapy for the Treatment of High-Risk Adults With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma","status":"RECRUITING","sponsor":"City of Hope Medical Center","startDate":"2025-10-10","conditions":["B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative","Lymphoblastic Lymphoma"],"enrollment":53,"completionDate":"2029-03-30"},{"nctId":"NCT00379340","phase":"PHASE3","title":"Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Newly Diagnosed Stage III or Stage IV Wilms' Tumor","status":"ACTIVE_NOT_RECRUITING","sponsor":"Children's Oncology Group","startDate":"2007-04-30","conditions":["Stage III Kidney Wilms Tumor","Stage IV Kidney Wilms Tumor"],"enrollment":395,"completionDate":"2026-11-18"},{"nctId":"NCT01679119","phase":"PHASE2","title":"Treatment of Patients With Diffuse Large B Cell Lymphoma Who Are Not Suitable for Anthracycline Containing Chemotherapy","status":"COMPLETED","sponsor":"University College, London","startDate":"2013-10","conditions":["Diffuse Large B Cell Lymphoma"],"enrollment":129,"completionDate":"2022-03"},{"nctId":"NCT02114229","phase":"PHASE2","title":"Phase 2 Study of Alisertib Therapy for Rhabdoid Tumors","status":"ACTIVE_NOT_RECRUITING","sponsor":"St. Jude Children's Research Hospital","startDate":"2014-05-14","conditions":["Malignant Rhabdoid Tumor","Atypical Teratoid Rhabdoid Tumor"],"enrollment":125,"completionDate":"2027-09"},{"nctId":"NCT00006721","phase":"PHASE3","title":"S0016 Combination Chemotherapy With Monoclonal Antibody Therapy in Newly Diagnosed Non-Hodgkin's Lymphoma","status":"COMPLETED","sponsor":"SWOG Cancer Research Network","startDate":"2001-03","conditions":["Lymphoma"],"enrollment":571,"completionDate":"2025-12"},{"nctId":"NCT07194044","phase":"PHASE1","title":"Metastatic Ewing's Trial Testing Schedule Enhancement to Improve Outcomes","status":"RECRUITING","sponsor":"H. Lee Moffitt Cancer Center and Research Institute","startDate":"2026-02","conditions":["Metastatic Ewing Sarcoma"],"enrollment":15,"completionDate":"2030-10"},{"nctId":"NCT04890093","phase":"PHASE1,PHASE2","title":"Vincristine and Temozolomide in Combination With PEN-866 for Adolescents and Young Adults With Relapsed or Refractory Solid Tumors","status":"SUSPENDED","sponsor":"National Cancer Institute (NCI)","startDate":"2024-10-31","conditions":["Sarcoma, Ewing","Rhabdomyosarcoma"],"enrollment":64,"completionDate":"2027-12-31"},{"nctId":"NCT06124157","phase":"PHASE3","title":"A Study Testing the Combination of Dasatinib or Imatinib to Chemotherapy Treatment With Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or ABL-Class Philadelphia Chromosome-Like (Ph-Like) B-cell Acute Lymphoblastic Leukemia (B-ALL)","status":"RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2025-05-30","conditions":["B Acute Lymphoblastic Leukemia"],"enrollment":222,"completionDate":"2030-12-01"},{"nctId":"NCT06738368","phase":"PHASE2","title":"Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) With or Without Rituximab Plus Recombinant Erwinia Asparaginase (JZP458) for the Treatment of Newly Diagnosed Ph Negative B-Acute Lymphoblastic Leukemia or T Acute Lymphoblastic Leukemia","status":"RECRUITING","sponsor":"University of Washington","startDate":"2026-04-01","conditions":["B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative","T Acute Lymphoblastic Leukemia"],"enrollment":30,"completionDate":"2028-07-30"},{"nctId":"NCT07133997","phase":"PHASE1","title":"Recombinant Erwinia Asparaginase and Venetoclax in Combination With Blinatumomab for the Treatment of Relapsed or Refractory CD19 Positive B-cell Acute Lymphoblastic Leukemia","status":"NOT_YET_RECRUITING","sponsor":"City of Hope Medical Center","startDate":"2026-06-01","conditions":["Recurrent B Acute Lymphoblastic Leukemia","Refractory B Acute Lymphoblastic Leukemia"],"enrollment":26,"completionDate":"2027-05-08"},{"nctId":"NCT05453500","phase":"PHASE2","title":"Chemotherapy (DA-EPOCH+/-R) and Targeted Therapy (Tafasitamab) for the Treatment of Newly-Diagnosed Philadelphia Chromosome Negative B Acute Lymphoblastic Leukemia","status":"RECRUITING","sponsor":"University of Washington","startDate":"2023-03-27","conditions":["B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative"],"enrollment":30,"completionDate":"2031-05-01"},{"nctId":"NCT06333899","phase":"EARLY_PHASE1","title":"Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion","status":"RECRUITING","sponsor":"Nationwide Children's Hospital","startDate":"2025-08-03","conditions":["High Grade Glioma","Diffuse Intrinsic Pontine Glioma","Anaplastic Astrocytoma","Infant Type Hemispheric Glioma","Glioblastoma","Glioblastoma Multiforme","WHO Grade III Glioma","WHO Grade IV Glioma","Diffuse Midline Glioma, H3K27-altered"],"enrollment":15,"completionDate":"2035-06-01"},{"nctId":"NCT05292664","phase":"PHASE1","title":"Venetoclax Basket Trial for High Risk Hematologic Malignancies","status":"RECRUITING","sponsor":"Andrew E. Place, MD","startDate":"2023-03-29","conditions":["Myelodysplastic Syndromes, de Novo","Myelodysplastic Syndromes, Secondary","Myelodysplastic Syndromes, Previously Treated","Treatment-Related Acute Myeloid Leukemia","Therapy-Related Myelodysplastic Syndrome","Acute Lymphoblastic Leukemia, in Relapse","Acute Lymphoblastic Leukemia With Failed Remission","Lymphoblastic Lymphoma, in Relapse","Lymphoblastic Lymphoma, Refractory","Acute Leukemia of Ambiguous Lineage in Relapse","Acute Leukemia of Ambiguous Lineage"],"enrollment":30,"completionDate":"2030-07-02"},{"nctId":"NCT07466316","phase":"PHASE3","title":"A Study Comparing Higher Dose Chemotherapy Over a Shorter Amount of Time to Lower Dose Chemotherapy Plus Maintenance Over a Longer Amount of Time in Patients With Newly Diagnosed Intermediate-Risk Rhabdomyosarcoma (IR RMS)","status":"NOT_YET_RECRUITING","sponsor":"Children's Oncology Group","startDate":"2026-06-22","conditions":["Rhabdomyosarcoma"],"enrollment":342,"completionDate":"2031-03-31"},{"nctId":"NCT06091254","phase":"PHASE3","title":"A Trial to Learn if Odronextamab is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Different Types of Chemotherapy for Adult Participants With Previously Untreated Follicular Lymphoma","status":"RECRUITING","sponsor":"Regeneron Pharmaceuticals","startDate":"2023-12-12","conditions":["Follicular Lymphoma (FL)"],"enrollment":822,"completionDate":"2029-11-03"},{"nctId":"NCT02723994","phase":"PHASE2","title":"A Phase 2 Study of Ruxolitinib With Chemotherapy in Children With Acute Lymphoblastic Leukemia","status":"COMPLETED","sponsor":"Incyte Corporation","startDate":"2016-09-30","conditions":["Leukemia"],"enrollment":171,"completionDate":"2026-03-03"},{"nctId":"NCT02213913","phase":"PHASE1,PHASE2","title":"Lenalidomide and Combination Chemotherapy (DA-EPOCH-R) in Treating Patients With MYC-Associated B-Cell Lymphomas","status":"COMPLETED","sponsor":"University of Chicago","startDate":"2014-07-29","conditions":["Adult Grade III Lymphomatoid Granulomatosis","B-cell Chronic Lymphocytic Leukemia","Contiguous Stage II Adult Diffuse Large Cell Lymphoma","Contiguous Stage II Adult Diffuse Mixed Cell Lymphoma","Contiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma","Contiguous Stage II Adult Immunoblastic Large Cell Lymphoma","Contiguous Stage II Grade 1 Follicular Lymphoma","Contiguous Stage II Grade 2 Follicular Lymphoma","Contiguous Stage II Grade 3 Follicular Lymphoma","Contiguous Stage II Mantle Cell Lymphoma","Contiguous Stage II Marginal Zone Lymphoma","Contiguous Stage II Small Lymphocytic Lymphoma","Cutaneous B-cell Non-Hodgkin Lymphoma","Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue","Intraocular Lymphoma","Nodal Marginal Zone B-cell Lymphoma","Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma","Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma","Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma","Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma","Noncontiguous Stage II Grade 1 Follicular Lymphoma","Noncontiguous Stage II Grade 2 Follicular Lymphoma","Noncontiguous Stage II Grade 3 Follicular Lymphoma","Noncontiguous Stage II Mantle Cell Lymphoma","Noncontiguous Stage II Marginal Zone Lymphoma","Noncontiguous Stage II Small Lymphocytic Lymphoma","Progressive Hairy Cell Leukemia, Initial Treatment","Small Intestine Lymphoma","Splenic Marginal Zone Lymphoma","Stage 0 Chronic Lymphocytic Leukemia","Stage I Adult Diffuse Large Cell Lymphoma","Stage I Adult Diffuse Mixed Cell Lymphoma","Stage I Adult Diffuse Small Cleaved Cell Lymphoma","Stage I Adult Hodgkin Lymphoma","Stage I Adult Immunoblastic Large Cell Lymphoma","Stage I Chronic Lymphocytic Leukemia","Stage I Grade 1 Follicular Lymphoma","Stage I Grade 2 Follicular Lymphoma","Stage I Grade 3 Follicular Lymphoma","Stage I Mantle Cell Lymphoma","Stage I Marginal Zone Lymphoma","Stage I Small Lymphocytic Lymphoma","Stage II Adult Hodgkin Lymphoma","Stage II Chronic Lymphocytic Leukemia","Stage II Small Lymphocytic Lymphoma","Stage III Adult Diffuse Large Cell Lymphoma","Stage III Adult Diffuse Mixed Cell Lymphoma","Stage III Adult Diffuse Small Cleaved Cell Lymphoma","Stage III Adult Hodgkin Lymphoma","Stage III Adult Immunoblastic Large Cell Lymphoma","Stage III Chronic Lymphocytic Leukemia","Stage III Grade 1 Follicular Lymphoma","Stage III Grade 2 Follicular Lymphoma","Stage III Grade 3 Follicular Lymphoma","Stage III Mantle Cell Lymphoma","Stage III Marginal Zone Lymphoma","Stage III Small Lymphocytic Lymphoma","Stage IV Adult Diffuse Large Cell Lymphoma","Stage IV Adult Diffuse Mixed Cell Lymphoma","Stage IV Adult Diffuse Small Cleaved Cell Lymphoma","Stage IV Adult Hodgkin Lymphoma","Stage IV Adult Immunoblastic Large Cell Lymphoma","Stage IV Chronic Lymphocytic Leukemia","Stage IV Grade 1 Follicular Lymphoma","Stage IV Grade 2 Follicular Lymphoma","Stage IV Grade 3 Follicular Lymphoma","Stage IV Mantle Cell Lymphoma","Stage IV Marginal Zone Lymphoma","Stage IV Small Lymphocytic Lymphoma","Testicular Lymphoma","Untreated Hairy Cell Leukemia","Waldenström Macroglobulinemia"],"enrollment":55,"completionDate":"2024-10-29"},{"nctId":"NCT06193759","phase":"PHASE1","title":"Immunotherapy for Malignant Pediatric Brain Tumors Employing Adoptive Cellular Therapy (IMPACT)","status":"RECRUITING","sponsor":"Children's National Research Institute","startDate":"2024-09-20","conditions":["Medulloblastoma, Childhood","Atypical Teratoid/Rhabdoid Tumor of CNS","Embryonal Tumor With Multilayered Rosettes","Pineoblastoma","Embryonal Brain Tumor Not Otherwise Specified","Ependymoma"],"enrollment":12,"completionDate":"2032-12-29"},{"nctId":"NCT03959085","phase":"PHASE3","title":"Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy","status":"RECRUITING","sponsor":"Children's Oncology Group","startDate":"2019-10-31","conditions":["B Acute Lymphoblastic Leukemia","B Lymphoblastic Lymphoma","Central Nervous System Leukemia","Mixed Phenotype Acute Leukemia","Testicular Leukemia"],"enrollment":5951,"completionDate":"2032-03-31"},{"nctId":"NCT05581030","phase":"PHASE1","title":"CalPeg for Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)","status":"RECRUITING","sponsor":"H. Lee Moffitt Cancer Center and Research Institute","startDate":"2023-05-01","conditions":["Acute Lymphoblastic Leukemia"],"enrollment":7,"completionDate":"2026-10"},{"nctId":"NCT07454226","phase":"NA","title":"ABL/JAK Inhibitors With Chemotherapy and Venetoclax for Ph-like ALL","status":"NOT_YET_RECRUITING","sponsor":"Institute of Hematology & Blood Diseases Hospital, China","startDate":"2026-03-01","conditions":["Ph-Like","Acute Lymphoblastic Leukemia"],"enrollment":30,"completionDate":"2030-03-01"},{"nctId":"NCT05157971","phase":"PHASE1","title":"Venetoclax and a Pediatric-Inspired Regimen for the Treatment of Newly Diagnosed B Cell Acute Lymphoblastic Leukemia","status":"RECRUITING","sponsor":"City of Hope Medical Center","startDate":"2022-03-17","conditions":["B Acute Lymphoblastic Leukemia","Ph-Like Acute Lymphoblastic Leukemia"],"enrollment":24,"completionDate":"2026-05-12"},{"nctId":"NCT06401330","phase":"PHASE3","title":"A Study Using Risk Factors to Determine Treatment for Children With Favorable Histology Wilms Tumors (FHWT)","status":"RECRUITING","sponsor":"Children's Oncology Group","startDate":"2025-04-15","conditions":["Stage I Mixed Cell Type Kidney Wilms Tumor","Stage II Mixed Cell Type Kidney Wilms Tumor","Stage III Mixed Cell Type Kidney Wilms Tumor","Stage IV Mixed Cell Type Kidney Wilms Tumor"],"enrollment":1656,"completionDate":"2031-02-13"},{"nctId":"NCT04623541","phase":"PHASE1,PHASE2","title":"Safety and Efficacy Study of Epcoritamab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome","status":"ACTIVE_NOT_RECRUITING","sponsor":"Genmab","startDate":"2020-11-25","conditions":["Relapsed/Refractory Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma","Richter's Syndrome","Treatment-naïve High Risk Chronic Lymphocytic Leukemia"],"enrollment":195,"completionDate":"2028-02"},{"nctId":"NCT04216524","phase":"PHASE2","title":"Venetoclax, SL-401, and Chemotherapy for the Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm","status":"RECRUITING","sponsor":"M.D. Anderson Cancer Center","startDate":"2020-05-29","conditions":["Blastic Plasmacytoid Dendritic Cell Neoplasm"],"enrollment":40,"completionDate":"2026-12-31"},{"nctId":"NCT07294677","phase":"PHASE1,PHASE2","title":"CApivasertib, Venetoclax And Low-intensity chemotheRapY for Adults With ALL/LBL","status":"RECRUITING","sponsor":"University of Chicago","startDate":"2026-03-17","conditions":["Leukemia","Lymphoma"],"enrollment":104,"completionDate":"2032-03"},{"nctId":"NCT07448480","phase":"","title":"Comprehensive Analysis of Chemotherapy and Targeted Therapy Outcomes in Recurrent Malignant Gliomas","status":"ACTIVE_NOT_RECRUITING","sponsor":"Blokhin's Russian Cancer Research Center","startDate":"2026-02-01","conditions":["Recurrent Malignant Glioma","Glioblastoma","Anaplastic Astrocytoma","Pleomorphic Xanthoastrocytoma"],"enrollment":1000,"completionDate":"2027-10-01"},{"nctId":"NCT07449949","phase":"","title":"A Single-Arm Study on the Efficacy of Sequential Chemoradiotherapy Followed by Surgery in Adult Nasal and Paranasal Sinus Rhabdomyosarcoma","status":"ENROLLING_BY_INVITATION","sponsor":"Eye & ENT Hospital of Fudan University","startDate":"2025-10-30","conditions":["ORR","PFS","OS"],"enrollment":43,"completionDate":"2030-12-30"},{"nctId":"NCT07444918","phase":"PHASE2","title":"Liposomal Irinotecan, Vincristine, Temozolomide, and Anlotinib for R/R Pediatric Solid Tumors","status":"NOT_YET_RECRUITING","sponsor":"Tianjin Medical University Cancer Institute and Hospital","startDate":"2026-03-01","conditions":["Relapsed or Refractory Pediatric Malignant Solid Tumors (Including Neuroblastoma, Rhabdomyosarcoma, Ewing Sarcoma, Osteosarcoma)"],"enrollment":33,"completionDate":"2032-06-06"},{"nctId":"NCT04663347","phase":"PHASE1,PHASE2","title":"Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Genmab","startDate":"2020-11-03","conditions":["Diffuse Large B-Cell Lymphoma","Follicular Lymphoma"],"enrollment":543,"completionDate":"2027-09-30"},{"nctId":"NCT06191744","phase":"PHASE3","title":"Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Previously Untreated Follicular Lymphoma","status":"RECRUITING","sponsor":"Genmab","startDate":"2024-02-05","conditions":["Follicular Lymphoma (FL)"],"enrollment":1095,"completionDate":"2037-11"},{"nctId":"NCT04542824","phase":"PHASE1,PHASE2","title":"Trial of the Safety and Efficacy of Epcoritamab in Japanese Subjects With Relapsed or Refractory (R/R) B-Cell Non-Hodgkin Lymphoma (R/R B-NHL)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Genmab","startDate":"2020-08-20","conditions":["Diffuse Large B Cell Lymphoma","High-grade B-cell Lymphoma","Primary Mediastinal Large B Cell Lymphoma","Follicular Lymphoma","Marginal Zone Lymphoma","Small Lymphocytic Lymphoma"],"enrollment":78,"completionDate":"2027-09"},{"nctId":"NCT05605899","phase":"PHASE3","title":"Study to Compare Axicabtagene Ciloleucel With Standard of Care Therapy as First-line Treatment in Participants With High-risk Large B-cell Lymphoma","status":"RECRUITING","sponsor":"Kite, A Gilead Company","startDate":"2023-02-10","conditions":["High-risk Large B-cell Lymphoma (LBCL)"],"enrollment":300,"completionDate":"2031-03"},{"nctId":"NCT06289673","phase":"PHASE4","title":"Identification of Necessary Information for Treatment Induction in Newly Diagnosed Acute Lymphoblastic Leukemia/Lymphoma","status":"RECRUITING","sponsor":"St. Jude Children's Research Hospital","startDate":"2024-12-26","conditions":["Acute Lymphoblastic Leukemia","Lymphoblastic Lymphoma","Mixed Phenotype Acute Leukemia"],"enrollment":850,"completionDate":"2039-05"},{"nctId":"NCT06541262","phase":"PHASE1,PHASE2","title":"Silmitasertib (CX-4945) in Combination With Chemotherapy for Relapsed Refractory Solid Tumors","status":"RECRUITING","sponsor":"Milton S. Hershey Medical Center","startDate":"2024-10-30","conditions":["Neuroblastoma","Ewing Sarcoma","Osteosarcoma","Rhabdomyosarcoma","Liposarcoma"],"enrollment":104,"completionDate":"2035-11-01"},{"nctId":"NCT03150693","phase":"PHASE3","title":"Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia","status":"SUSPENDED","sponsor":"Alliance for Clinical Trials in Oncology","startDate":"2017-09-20","conditions":["B Acute Lymphoblastic Leukemia"],"enrollment":310,"completionDate":"2027-08"},{"nctId":"NCT05289687","phase":"PHASE2","title":"Daratumumab for Chemotherapy-Refractory Minimal Residual Disease in T Cell ALL","status":"RECRUITING","sponsor":"Eastern Cooperative Oncology Group","startDate":"2023-05-25","conditions":["T-cell Acute Lymphoblastic Leukemia"],"enrollment":20,"completionDate":"2027-06-30"},{"nctId":"NCT06045247","phase":"PHASE2","title":"Phase 2 Trial of Epcoritamab in Combination With Rituximab-mini CVP for Older Unfit/Frail Patients or Anthracycline-Ineligible Adult Patients With Newly Diagnosed Diffuse Large B-cell Lymphoma","status":"RECRUITING","sponsor":"M.D. Anderson Cancer Center","startDate":"2024-01-05","conditions":["Large B-cell Lymphoma"],"enrollment":40,"completionDate":"2030-07-31"},{"nctId":"NCT03126916","phase":"PHASE3","title":"Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)","status":"RECRUITING","sponsor":"Children's Oncology Group","startDate":"2018-05-14","conditions":["Ganglioneuroblastoma","Ganglioneuroblastoma, Nodular","Neuroblastoma"],"enrollment":750,"completionDate":"2030-09-30"},{"nctId":"NCT06390319","phase":"PHASE2","title":"Adding Dasatinib Or Venetoclax To Improve Responses In Children With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (ALL) Or Lymphoma (T-LLY) Or Mixed Phenotype Acute Leukemia (MPAL)","status":"RECRUITING","sponsor":"St. Jude Children's Research Hospital","startDate":"2024-12-27","conditions":["T-cell Acute Lymphoblastic Leukemia","T-cell Lymphoma","Mixed Phenotype Acute Leukemia"],"enrollment":100,"completionDate":"2033-12"},{"nctId":"NCT06942039","phase":"EARLY_PHASE1","title":"Pilot Study of IT Topotecan and Maintenance Chemotherapy for HR-EBTs in Children < 6 Years, Post Consolidation","status":"RECRUITING","sponsor":"C17 Council","startDate":"2025-09-23","conditions":["CNS Embryonal Tumor","CNS, Medulloblastoma","Atypical Teratoid Rhabdoid Tumor","Medulloblastoma, Childhood","Medulloblastoma, Group 3","Medulloblastoma, Group 4","Pineoblastoma","Neuroblastoma","Embryonal Tumor With Multilayered Rosettes","Embryonal Tumor With Abundant Neuropil and True Rosettes","Ependymoblastoma","Medulloepithelioma","CNS Embryonal Tumor With Rhabdoid Features","CNS Embryonal Tumor, Nos"],"enrollment":15,"completionDate":"2032-12-31"},{"nctId":"NCT03504644","phase":"PHASE1,PHASE2","title":"Venetoclax and Vincristine in Treating Patients With Relapsed or Refractory T-cell or B-cell Acute Lymphoblastic Leukemia","status":"ACTIVE_NOT_RECRUITING","sponsor":"ECOG-ACRIN Cancer Research Group","startDate":"2018-08-13","conditions":["Recurrent Adult Lymphoblastic Lymphoma","Recurrent B Acute Lymphoblastic Leukemia","Recurrent B Lymphoblastic Lymphoma","Recurrent T Acute Lymphoblastic Leukemia","Recurrent T Lymphoblastic Lymphoma","Refractory B Acute Lymphoblastic Leukemia","Refractory B Lymphoblastic Lymphoma","Refractory T Acute Lymphoblastic Leukemia","Refractory T Lymphoblastic Lymphoma"],"enrollment":40,"completionDate":"2028-12-31"},{"nctId":"NCT05382338","phase":"PHASE3","title":"A Study of Treatment for Medulloblastoma Using Sodium Thiosulfate to Reduce Hearing Loss","status":"RECRUITING","sponsor":"Children's Oncology Group","startDate":"2023-02-20","conditions":["Childhood Medulloblastoma"],"enrollment":225,"completionDate":"2029-12-31"},{"nctId":"NCT06647953","phase":"PHASE3","title":"Testing a Standardized Approach to Surgery and Chemotherapy for Type I Pleuropulmonary Blastoma or the Addition of an Anti-cancer Drug, Topotecan, to the Usual Treatment for Types II and III Pleuropulmonary Blastoma","status":"RECRUITING","sponsor":"Children's Oncology Group","startDate":"2025-03-21","conditions":["Pleuropulmonary Blastoma"],"enrollment":110,"completionDate":"2029-03-31"},{"nctId":"NCT07431060","phase":"NA","title":"Modified LCH-III Regimen With or Without Luvometinib for Multisystem Pediatric Langerhans Cell Histiocytosis","status":"RECRUITING","sponsor":"West China Second University Hospital","startDate":"2026-02-13","conditions":["Langerhans Cell Histiocytosis (LCH)"],"enrollment":120,"completionDate":"2030-12-31"},{"nctId":"NCT04322318","phase":"PHASE2","title":"A Study of Combination Chemotherapy for Patients With Newly Diagnosed DAWT and Relapsed FHWT","status":"RECRUITING","sponsor":"Children's Oncology Group","startDate":"2020-10-19","conditions":["Anaplastic Kidney Wilms Tumor","Recurrent Kidney Wilms Tumor","Stage II Kidney Wilms Tumor","Stage III Kidney Wilms Tumor","Stage IV Kidney Wilms Tumor"],"enrollment":256,"completionDate":"2027-07-01"},{"nctId":"NCT05304585","phase":"PHASE3","title":"Chemotherapy for the Treatment of Patients With Newly Diagnosed Very Low-Risk and Low Risk Fusion Negative Rhabdomyosarcoma","status":"RECRUITING","sponsor":"Children's Oncology Group","startDate":"2022-08-04","conditions":["Embryonal Rhabdomyosarcoma","Fusion-Negative Alveolar Rhabdomyosarcoma","Spindle Cell/Sclerosing Rhabdomyosarcoma"],"enrollment":205,"completionDate":"2030-06-30"},{"nctId":"NCT01946529","phase":"PHASE2","title":"Therapeutic Trial for Patients With Ewing Sarcoma Family of Tumor and Desmoplastic Small Round Cell Tumors","status":"ACTIVE_NOT_RECRUITING","sponsor":"St. Jude Children's Research Hospital","startDate":"2013-12-27","conditions":["Desmoplastic Small Round Cell Tumor","Ewing Sarcoma of Bone or Soft Tissue","Localized Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor","Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor"],"enrollment":24,"completionDate":"2026-07"},{"nctId":"NCT03007147","phase":"PHASE3","title":"Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia","status":"ACTIVE_NOT_RECRUITING","sponsor":"Children's Oncology Group","startDate":"2017-08-08","conditions":["Acute Lymphoblastic Leukemia","B Acute Lymphoblastic Leukemia","Mixed Phenotype Acute Leukemia","T Acute Lymphoblastic Leukemia"],"enrollment":475,"completionDate":"2027-09-30"},{"nctId":"NCT03755804","phase":"PHASE2","title":"Pediatric Classical Hodgkin Lymphoma Consortium Study: cHOD17","status":"ACTIVE_NOT_RECRUITING","sponsor":"St. Jude Children's Research Hospital","startDate":"2018-12-12","conditions":["Hodgkin Lymphoma"],"enrollment":232,"completionDate":"2028-07-01"},{"nctId":"NCT02981628","phase":"PHASE2","title":"Inotuzumab Ozogamicin in Treating Younger Patients With B-Lymphoblastic Lymphoma or Relapsed or Refractory CD22 Positive B Acute Lymphoblastic Leukemia","status":"RECRUITING","sponsor":"Children's Oncology Group","startDate":"2017-06-19","conditions":["Recurrent B Acute Lymphoblastic Leukemia","Recurrent B Lymphoblastic Lymphoma","Refractory B Acute Lymphoblastic Leukemia","Refractory B Lymphoblastic Lymphoma"],"enrollment":80,"completionDate":"2026-12-31"},{"nctId":"NCT04002947","phase":"PHASE2","title":"Acalabrutinib With DA-EPOCH-R or R-CHOP for People With Untreated Diffuse Large B-cell Lymphoma","status":"RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2019-08-05","conditions":["Non-Hodgkin's Lymphoma","Diffuse Large B-Cell Lymphoma","DLBCL","NHL"],"enrollment":132,"completionDate":"2030-03-31"},{"nctId":"NCT05389423","phase":"PHASE1","title":"Pomalidomide and Dose-Adjusted EPOCH +/- Rituximab for HIV-Associated Lymphomas","status":"RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2023-06-27","conditions":["Diffuse Large Cell Lymphoma","Non-Hodgkin Lymphoma","Burkitt Lymphoma","Plasmablastic Lymphoma","B-Cell Neoplasm"],"enrollment":25,"completionDate":"2032-06-01"},{"nctId":"NCT03407144","phase":"PHASE2","title":"Safety and Efficacy of Pembrolizumab (MK-3475) in Children and Young Adults With Classical Hodgkin Lymphoma (MK-3475-667/KEYNOTE-667)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Merck Sharp & Dohme LLC","startDate":"2018-04-09","conditions":["Hodgkin Lymphoma"],"enrollment":340,"completionDate":"2026-11-06"},{"nctId":"NCT06709495","phase":"PHASE1,PHASE2","title":"Phase 1/2 Trial to Evaluate the Safety and Efficacy of PEEL-224 in Combination With Vincristine and Temozolomide in Adolescents and Young Adults With Relapsed or Refractory Sarcomas","status":"RECRUITING","sponsor":"David S Shulman, MD","startDate":"2025-01-27","conditions":["Sarcoma","Sarcoma, Ewing","Desmoplastic Small Round Cell Tumor","Refractory Sarcoma","Osteosarcoma","Rhabdomyosarcoma"],"enrollment":63,"completionDate":"2029-09-01"},{"nctId":"NCT04199026","phase":"NA","title":"Implantable Microdevice for the Delivery of Drugs and Their Effect on Tumors in Patients With Metastatic or Recurrent Sarcoma","status":"RECRUITING","sponsor":"M.D. Anderson Cancer Center","startDate":"2025-02-25","conditions":["Metastatic Sarcoma","Recurrent Sarcoma","Resectable Sarcoma"],"enrollment":20,"completionDate":"2028-12-31"},{"nctId":"NCT00352534","phase":"PHASE3","title":"Vincristine, Dactinomycin, and Doxorubicin With or Without Radiation Therapy or Observation Only in Treating Younger Patients Who Are Undergoing Surgery for Newly Diagnosed Stage I, Stage II, or Stage III Wilms' Tumor","status":"ACTIVE_NOT_RECRUITING","sponsor":"Children's Oncology Group","startDate":"2006-11-06","conditions":["Stage I Kidney Wilms Tumor","Stage II Kidney Wilms Tumor","Stage III Kidney Wilms Tumor"],"enrollment":808,"completionDate":"2026-03-31"},{"nctId":"NCT04570423","phase":"PHASE2","title":"A Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Participants With Solid Tumors or Lymphomas and Treated With Myelosuppressive Chemotherapy","status":"RECRUITING","sponsor":"Spectrum Pharmaceuticals, Inc","startDate":"2021-05-20","conditions":["Solid Tumors","Lymphoma"],"enrollment":40,"completionDate":"2027-10"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"Intravenous","formulation":"Injection","formulations":[{"form":"INJECTION, SOLUTION","route":"INTRAVENOUS","productName":"VinCRIStine Sulfate"},{"form":"INJECTION, SOLUTION","route":"INTRAVENOUS","productName":"Vincasar PFS"}]},"_patentsChecked":true,"crossReferences":{"NUI":"N0000148056","MMSL":"5133","NDDF":"002656","UNII":"5J49Q6B70F","VUID":"4019971","CHEBI":"CHEBI:28445","VANDF":"4017542","INN_ID":"1440","RXNORM":"11202","UMLSCUI":"C0042679","chemblId":"CHEMBL501867","ChEMBL_ID":"CHEMBL90555","KEGG_DRUG":"D02197","DRUGBANK_ID":"DB00541","PDB_CHEM_ID":" R1Q","PUBCHEM_CID":"5978","SNOMEDCT_US":"23079006","IUPHAR_LIGAND_ID":"6785","SECONDARY_CAS_RN":"2068-78-2","MESH_DESCRIPTOR_UI":"D014750"},"formularyStatus":[],"_enricherVersion":"v2","_offLabelChecked":true,"developmentCodes":[],"ownershipHistory":[{"period":"present","companyName":"Eli Lilly","relationship":"Current Owner"}],"pharmacokinetics":{"source":"DrugCentral","halfLife":"23.0 hours","clearance":"2.0 mL/min/kg","fractionUnbound":"0.4%","volumeOfDistribution":"2.4 L/kg"},"publicationCount":556,"therapeuticAreas":["Oncology"],"atcClassification":{"source":"DrugCentral","atcCode":"L01CA02","allCodes":["L01CA02"]},"biosimilarFilings":[],"recentPublications":[{"date":"2026 Feb 2","pmid":"41718415","title":"Fluid Overload-Associated Large B-Cell Lymphoma Presenting as Isolated Pleural Effusion.","journal":"Hematology reports"},{"date":"2026 Feb","pmid":"41608764","title":"Bispecific Antibodies Versus Chimeric Antigen Receptor T-Cell Therapy in Relapsed/Refractory Diffuse Large B-Cell Lymphoma: A Comparative Narrative Review of Efficacy, Safety, and Accessibility.","journal":"Cancer medicine"},{"date":"2025 Nov 5","pmid":"41194119","title":"Probiotic-enhanced chemotherapy: Lactobacillus fermentum synergizes with vincristine to induce apoptosis via dual pathway activation in human cancer cells.","journal":"Cancer cell international"},{"date":"2025 Oct 6","pmid":"41047434","title":"Combinational therapy of cervical cancer consisting of probiotic particles and vincristine: a molecular in vitro study.","journal":"Medical oncology (Northwood, London, England)"}],"companionDiagnostics":[],"genericManufacturers":7,"_genericFilersChecked":true,"genericManufacturerList":["Abic","Abraxis Pharm","Bristol Myers Squibb","Fresenius Kabi Usa","Hospira","Teva Parenteral","Teva Pharms Usa"],"status":"approved","companyName":"Lilly","companyId":"pfizer","modality":"Small molecule","firstApprovalDate":"1963","enrichmentLevel":4,"visitCount":8,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1987-07-17T00:00:00.000Z","mah":"TEVA PARENTERAL","brand_name_local":"VINCASAR PFS","application_number":"ANDA071426"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1997-04-16T00:00:00.000Z","mah":"HOSPIRA","brand_name_local":null,"application_number":"ANDA071484"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2002-12-20T00:00:00.000Z","mah":"FRESENIUS KABI USA","brand_name_local":"VINCRISTINE SULFATE","application_number":"ANDA076296"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2012-08-09T00:00:00.000Z","mah":"ACROTECH","brand_name_local":"MARQIBO KIT","application_number":"NDA202497"},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":"ABRAXIS PHARM","brand_name_local":"VINCRISTINE SULFATE","application_number":"ANDA070411"},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":96,"withResults":56},"validation":{"fieldsValidated":3,"lastValidatedAt":"2026-04-19T23:33:03.888571+00:00","fieldsConflicting":14,"overallConfidence":0.8},"verificationStatus":"verified","dataCompleteness":{"mechanism":false,"indications":true,"safety":true,"trials":true,"score":3}}