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Dasatinib, Cytarabine, and Idarubicin in Treating Patients With High-Risk Acute Myeloid Leukemia
Phase 1, PHASE2 trial testing cytarabine in Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities in 20 participants. Terminated before completion.
| Lead sponsor | City of Hope Medical Center |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 13 September 2013 |
| Primary completion | 25 April 2018 |
| Estimated completion | 25 April 2018 |
| Sites | 1 location across United States |
City of Hope Medical Center
18 and older, any sex, with Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities or Adult Acute Myeloid Leukemia With Del(5q). 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 of dasatinib, determined according to incidence of dose limiting toxicity (DLT), graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I)
| Group | Value | 95% CI |
|---|---|---|
| Dasatinib 100mg/Day + Cytarabine 200mg/m2/Day + Idarubicin 12mg/m2/Day | 100 |
Time frame: Adverse event and vital status data were captured from the initial treatment to off study, up to 2 years.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Dasatinib 100mg/Day + Cyta… | Dasatinib 140mg/Day + Cyta… |
|---|---|---|---|
| Death NOS | General disorders | — | — |
| Multi-organ failure | General disorders | — | — |
| Intracranial hemorrhage | Nervous system disorders | — | — |
| Adult respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | — | — |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | — | — |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | — | — |
| Reaction | System | Dasatinib 100mg/Day + Cyta… | Dasatinib 140mg/Day + Cyta… |
|---|---|---|---|
| 10035528-Platelet count decreased | Investigations | — | — |
| 10002272-Anemia | Blood and lymphatic system disorders | — | — |
| 10049182-White blood cell decreased | Investigations | — | — |
| 10021038-Hyponatremia | Metabolism and nutrition disorders | — | — |
| 10020772-Hypertension | Vascular disorders | — | — |
| 10025256-Lymphocyte count decreased | Investigations | — | — |
| 10028813-Nausea | Gastrointestinal disorders | — | — |
| 10016558-Fever | General disorders | — | — |
| 10020943-Hypoalbuminemia | Metabolism and nutrition disorders | — | — |
| 10040752-Sinus tachycardia | Cardiac disorders | — | — |
| 10012727-Diarrhea | Gastrointestinal disorders | — | — |
| 10029366-Neutrophil count decreased | Investigations | — | — |
| 10020949-Hypocalcemia | Metabolism and nutrition disorders | — | — |
| 10021018-Hypokalemia | Metabolism and nutrition disorders | — | — |
| 10005364-Blood bilirubin increased | Investigations | — | — |
| 10037868-Rash maculo-papular | Skin and subcutaneous tissue disorders | — | — |
| 10016256-Fatigue | General disorders | — | — |
| 10002646-Anorexia | Metabolism and nutrition disorders | — | — |
| 10028130-Mucositis oral | Gastrointestinal disorders | — | — |
| 10047700-Vomiting | Gastrointestinal disorders | — | — |
| 10050068-Edema limbs | General disorders | — | — |
| 10001551-Alanine aminotransferase increased | Investigations | — | — |
| 10003481-Aspartate aminotransferase increased | Investigations | — | — |
| 10047900-Weight loss | Investigations | — | — |
| 10019211-Headache | Nervous system disorders | — | — |
| 10010774-Constipation | Gastrointestinal disorders | — | — |
| 10003988-Back pain | Musculoskeletal and connective tissue disorders | — | — |
| 10002855-Anxiety | Psychiatric disorders | — | — |
| 10040741-Sinus bradycardia | Cardiac disorders | — | — |
| 10000081-Abdominal pain | Gastrointestinal disorders | — | — |
| 10001675-Alkaline phosphatase increased | Investigations | — | — |
| 10047896-Weight gain | Investigations | — | — |
| 10021059-Hypophosphatemia | Metabolism and nutrition disorders | — | — |
| 10037087-Pruritus | Skin and subcutaneous tissue disorders | — | — |
| 10016288-Febrile neutropenia | Blood and lymphatic system disorders | — | — |
| 10013781-Dry mouth | Gastrointestinal disorders | — | — |
| 10011368-Creatinine increased | Investigations | — | — |
| 10020670-Hypermagnesemia | Metabolism and nutrition disorders | — | — |
| 10022437-Insomnia | Psychiatric disorders | — | — |
| 10013963-Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — |
Most-reported serious reactions: Death NOS, Multi-organ failure, Intracranial hemorrhage, Adult respiratory distress syndrome, Hypoxia, Respiratory failure.
Data from ClinicalTrials.gov NCT01876953 adverse events section.
This phase I/II trial studies the side effects and best dose of dasatinib when given together with cytarabine and idarubicin hydrochloride and to see how well they work in treating patients with acute myeloid leukemia that is likely to come back or spread. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cytarabine and idarubicin hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving dasatinib together with cytarabine and idarubicin hydrochloride may be a better treatment for acute myeloid leukemia.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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