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Ruxolitinib Phosphate and Decitabine in Treating Patients With Relapsed or Refractory or Post Myeloproliferative Acute Myeloid Leukemia
Phase 1, PHASE2 trial testing Decitabine in Blasts More Than 20 Percent of Bone Marrow Nucleated Cells in 30 participants. Completed in 19 March 2021.
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 12 February 2015 |
| Primary completion | 19 March 2021 |
| Estimated completion | 19 March 2021 |
| Sites | 1 location across United States |
M.D. Anderson Cancer Center — full company profile →
18 and older, any sex, with Blasts More Than 20 Percent of Bone Marrow Nucleated Cells or Blasts More Than 20 Percent of Peripheral Blood White Cells. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Maximum tolerated dose (MTD) is defined as the highest dose studied for which the incidence of dose-limiting toxicity (DLT) is less than or equal to 17% (1 out of 6).
| Group | Value | 95% CI |
|---|---|---|
| Ph1 (MTD) Treatment (Ruxolitinib Phosphate, Decitabine) | NA |
Complete Response (CR) is defined as - The participant must be free of all symptoms related to leukemia and have an absolute neutrophil count \>/= 1 z 10\^9/L, no need for red blood cell transfusion, platelet count\>/+ 100 x 10\^9/L, and normal marrow differential (\</= 5 % blasts) in a normo- or hypercellular marrow. Complete Response with incomplete blood count recovery (CRi) is defined as - Same as CR but incomplete count recovery.
| Group | Value | 95% CI |
|---|---|---|
| Ph2 Treatment (Ruxolitinib Phosphate, Decitabine) | 8 |
JAK2 mutations were assessed with the baseline Bone Marrow or Peripheral Blood.
| Group | Value | 95% CI |
|---|---|---|
| Ph2 Treatment (Ruxolitinib Phosphate, Decitabine) | 11 |
JAK2 mutations were assessed with the baseline Bone Marrow or Peripheral Blood. Complete Response (CR) is defined as - The participant must be free of all symptoms related to leukemia and have an absolute neutrophil count \>/= 1 z 10\^9/L, no need for red blood cell transfusion, platelet count\>/+ 100 x 10\^9/L, and normal marrow differential (\</= 5 % blasts) in a normo- or hypercellular marrow. Complete Response with incomplete blood count recovery (CRi) is defined as - Same as CR but incomplete count recovery.
| Group | Value | 95% CI |
|---|---|---|
| Ph2 Treatment (Ruxolitinib Phosphate, Decitabine) | 5 |
| Group | Value | 95% CI |
|---|---|---|
| Ph2 Treatment (Ruxolitinib Phosphate, Decitabine) | 3 |
Time frame: Up to 6 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Ph1 (MTD) 10mg | Ph1 (MTD) 15mg | Ph1 (MTD) 25mg | Ph1 (MTD) 50mg | Ph2 Treatment (Ruxolitinib… |
|---|---|---|---|---|---|---|
| Lung Infection | Infections and infestations | — | — | — | — | — |
| Febrile Neutropenia | Blood and lymphatic system disorders | — | — | — | — | — |
| Colitis | Gastrointestinal disorders | — | — | — | — | — |
| Infection | Infections and infestations | — | — | — | — | — |
| Soft Tissue Infection | Infections and infestations | — | — | — | — | — |
| Acute Kidney Injury | Renal and urinary disorders | — | — | — | — | — |
| Atrial fibrillation | Cardiac disorders | — | — | — | — | — |
| Blood and Lymphatic System Disorders | Blood and lymphatic system disorders | — | — | — | — | — |
| Supraventricular and nodal arrhythmia | Cardiac disorders | — | — | — | — | — |
| Fatigue | General disorders | — | — | — | — | — |
| Fever | General disorders | — | — | — | — | — |
| Fracture | Injury, poisoning and procedural complications | — | — | — | — | — |
| Hypercalcemia | Metabolism and nutrition disorders | — | — | — | — | — |
| Intracranial Hemorrhage | Nervous system disorders | — | — | — | — | — |
| Muscle Weakness | Musculoskeletal and connective tissue disorders | — | — | — | — | — |
| Lung Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — | — |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | — | — | — | — | — |
| Sepsis | Infections and infestations | — | — | — | — | — |
| Lower Extremity Rash | Skin and subcutaneous tissue disorders | — | — | — | — | — |
| Spinal Fracture | Injury, poisoning and procedural complications | — | — | — | — | — |
| Upper Gastrointestinal Hemorrhage | Gastrointestinal disorders | — | — | — | — | — |
| Hypotension | Vascular disorders | — | — | — | — | — |
| Reaction | System | Ph1 (MTD) 10mg | Ph1 (MTD) 15mg | Ph1 (MTD) 25mg | Ph1 (MTD) 50mg | Ph2 Treatment (Ruxolitinib… |
|---|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | — | — | — | — | — |
| Infection | Infections and infestations | — | — | — | — | — |
| Elevated Bilirubin | Investigations | — | — | — | — | — |
| Diarrhea | Gastrointestinal disorders | — | — | — | — | — |
| Fatigue | General disorders | — | — | — | — | — |
| Febrile Neutropenia | Blood and lymphatic system disorders | — | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — | — |
| Pain | General disorders | — | — | — | — | — |
| Alkaline Phosphatase | Investigations | — | — | — | — | — |
| Anorexia | Gastrointestinal disorders | — | — | — | — | — |
| Bruising | General disorders | — | — | — | — | — |
| Hypercalcemia | Metabolism and nutrition disorders | — | — | — | — | — |
| Cardiac Arrythmia | Cardiac disorders | — | — | — | — | — |
| Elevated Creatinine | Investigations | — | — | — | — | — |
| Dizziness | Nervous system disorders | — | — | — | — | — |
| Dry Mouth | Gastrointestinal disorders | — | — | — | — | — |
| Edema Limbs | General disorders | — | — | — | — | — |
| Hyperglycemia | Metabolism and nutrition disorders | — | — | — | — | — |
| Hemorrhage Gastrointestial | Gastrointestinal disorders | — | — | — | — | — |
| Hemorrhage Other | General disorders | — | — | — | — | — |
| Hypotension | Vascular disorders | — | — | — | — | — |
| Mucositis | Gastrointestinal disorders | — | — | — | — | — |
| Petechiae | General disorders | — | — | — | — | — |
| Hyperkalemia | Metabolism and nutrition disorders | — | — | — | — | — |
| Pruritis/itching | Skin and subcutaneous tissue disorders | — | — | — | — | — |
| Renal Failure | Renal and urinary disorders | — | — | — | — | — |
| Renal/Genitourinary Other | Renal and urinary disorders | — | — | — | — | — |
| Hyponatremia | Metabolism and nutrition disorders | — | — | — | — | — |
| Weight loss | General disorders | — | — | — | — | — |
Most-reported serious reactions: Lung Infection, Febrile Neutropenia, Colitis, Infection, Soft Tissue Infection, Acute Kidney Injury, Atrial fibrillation, Blood and Lymphatic System Disorders.
Data from ClinicalTrials.gov NCT02257138 adverse events section.
This phase I/II trial studies the side effects and best dose of ruxolitinib phosphate when given together with decitabine and to see how well they work in treating patients with acute myeloid leukemia that has come back or is not responding to treatment, or has developed from a type of bone marrow diseases called myeloproliferative neoplasms. Ruxolitinib phosphate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ruxolitinib phosphate together with decitabine may be an effective treatment for acute myeloid leukemia.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02257138.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing