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Flavopiridol to Treat Relapsed Mantle Cell Lymphoma or Diffuse Large B-Cell Lymphoma
Phase 1, PHASE2 trial testing Flavopiridol in Lymphoma in 28 participants. Completed in 18 October 2012.
| Lead sponsor | National Cancer Institute (NCI) |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 28 |
| Start date | 27 November 2006 |
| Primary completion | 30 April 2012 |
| Estimated completion | 18 October 2012 |
| Sites | 1 location across United States |
National Cancer Institute (NCI)
18 and older, any sex, with Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.
| Group | Value | 95% CI |
|---|---|---|
| Flavopiridol in Lymphoma Patients | 28 |
Response was assessed by the Cheson criteria. Complete response is complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related symptoms if present before therapy, and normalization of those biochemical abnormalities (e.g.(LDH) definitely assignable to the lymphoma. All lymph nodes must have regressed to normal size (\</= 1.5 cm in greatest diameter if \> 1.5 cm before therapy). Previously involved nodes that were 1.1 to 1.5 cm in greatest diameter must have decreased to \</= 1 cm or by more than 75% in the sum of the products
| Group | Value | 95% CI |
|---|---|---|
| Flavopiridol in Lymphoma Patients | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Flavopiridol in Lymphoma Patients | 2 |
Time frame: 47 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Flavopiridol in Lymphoma P… |
|---|---|---|
| Creatinine | Metabolism and nutrition disorders | — |
| Leukocytes (total WBC) | Blood and lymphatic system disorders | — |
| Tumor lysis syndrome | Metabolism and nutrition disorders | — |
| Hemorrhage, GI::Rectum | Gastrointestinal disorders | — |
| Hypotension | Cardiac disorders | — |
| Lymphopenia | Blood and lymphatic system disorders | — |
| Platelets | Blood and lymphatic system disorders | — |
| Supraventricular and nodal arrhythmia::Sinus tachycardia | Cardiac disorders | — |
| Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | — |
| Cardiac troponin I (cTnI) | Cardiac disorders | — |
| Conduction abnormality/atrioventricular heart block::AV Block-Third degree (Complete AV block) | Cardiac disorders | — |
| Confusion | Nervous system disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Dizziness | Nervous system disorders | — |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | — |
| Edema: head and neck | Blood and lymphatic system disorders | — |
| Edema: limb | Blood and lymphatic system disorders | — |
| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | General disorders | — |
| Heartburn/dyspepsia | Gastrointestinal disorders | — |
| Hemoglobin | Blood and lymphatic system disorders | — |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | — |
| Infection | Infections and infestations | — |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Blood | Infections and infestations | — |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Lung (pneumonia) | Infections and infestations | — |
| Muscle weakness, generalized or specific area (not due to neuropathy)::Whole body/generalized | Musculoskeletal and connective tissue disorders | — |
| Reaction | System | Flavopiridol in Lymphoma P… |
|---|---|---|
| Lymphopenia | Blood and lymphatic system disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Leukocytes (total WBC) | Blood and lymphatic system disorders | — |
| Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | — |
| AST, SGOT(serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Hemoglobin | Blood and lymphatic system disorders | — |
| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | — |
| Platelets | Blood and lymphatic system disorders | — |
| Phosphate, serum-low (hypophosphatemia) | Metabolism and nutrition disorders | — |
| Alkaline phosphatase | Metabolism and nutrition disorders | — |
| Magnesium, serum-low (hypomagnesemia) | Metabolism and nutrition disorders | — |
| Sodium, serum-low (hyponatremia) | Metabolism and nutrition disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | — |
| Bilirubin (hyperbilirubinemia) | Metabolism and nutrition disorders | — |
| Magnesium, serum-high (hypermagnesemia) | Metabolism and nutrition disorders | — |
| Bicarbonate, serum-low | Metabolism and nutrition disorders | — |
| Calcium, serum-low (hypocalcemia) | Metabolism and nutrition disorders | — |
| Creatinine | Metabolism and nutrition disorders | — |
| Fatigue (asthenia, lethargy, malaise) | General disorders | — |
| Anorexia | Gastrointestinal disorders | — |
| Potassium, serum-low (hypokalemia) | Metabolism and nutrition disorders | — |
| Sodium, serum-high (hypernatremia) | Metabolism and nutrition disorders | — |
| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | General disorders | — |
| Hypotension | Cardiac disorders | — |
| Potassium, serum-high (hyperkalemia) | Metabolism and nutrition disorders | — |
| Edema: limb | Blood and lymphatic system disorders | — |
| Glucose, serum-high (hyperglycemia) | Metabolism and nutrition disorders | — |
| PTT (Partial Thromboplastin Time) | Blood and lymphatic system disorders | — |
| Uric acid, serum-high (hyperuricemia) | Metabolism and nutrition disorders | — |
| CPK (creatine phosphokinase) | Metabolism and nutrition disorders | — |
| Calcium, serum-high (hypercalcemia) | Metabolism and nutrition disorders | — |
| Pain::Bone | Musculoskeletal and connective tissue disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Dizziness | Nervous system disorders | — |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | — |
| Pain::Abdomen NOS | Reproductive system and breast disorders | — |
| Syncope (fainting) | Nervous system disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
Most-reported serious reactions: Creatinine, Leukocytes (total WBC), Tumor lysis syndrome, Hemorrhage, GI::Rectum, Hypotension, Lymphopenia, Platelets, Supraventricular and nodal arrhythmia::Sinus tachycardia.
Data from ClinicalTrials.gov NCT00445341 adverse events section.
Background: Mantle cell lymphoma (MCL) and diffuse large B-cell lymphoma (DLBCL) are aggressive subtypes of non-Hodgkin lymphoma. Flavopiridol is an investigational drug that works differently from standard chemotherapy and may target abnormalities in MCL and DLBCL cells, such as a protein excess that prevents tumor cells from dying. A challenge in developing flavopiridol for treatment has been determining its optimal dosing schedule. The schedule used for this study is effective in a type of leukemia called chronic lymphocytic leukemia (CLL) and may benefit patients with MCL and DLBCL also. Objectives: To determine the highest dose of flavopiridol that can be given safely to patients with relapsed MCL and DLBCL at the dosing schedule detailed below To assess the response of the tumor to flavopiridol given at the test dosing schedule Eligibility: Patients 18 years of age and older with relapsed MCL or DLBCL Design: Flavopiridol is given at four different dose levels, starting with the lowest dose for the first group of three to six patients and increasing with subsequent groups, depending on side effects at the preceding dose. The drug is given weekly for 4 weeks followed by a 2-week break (one cycle) for up to six cycles. It is given through a vein as a 30-minute infusion followed by a 4-hour infusion. Patients undergo the following procedures for research studies and to evaluate the effect of treatment on the tumor: * Blood tests * Lymph node, bone marrow and tumor biopsies * Lymphapheresis to collect blood cells for research * Disease staging with imaging studies (computed tomography (CT), positron emission tomography (PET) and/or magnetic resonance imaging (MRI) after every 2 cycles
8 peer-reviewed publications reference this trial (live from Europe PMC):
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