Spots Global Cancer Trial Database for Idarubicin and High-Dose Cytarabine in Treating Patients With Acute Myeloid Leukemia

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Trial Identification

Brief Title: Idarubicin and High-Dose Cytarabine in Treating Patients With Acute Myeloid Leukemia

Official Title: Phase II Trial Utilizing Idarubicin in Combination With High Dose Ara-C for Induction Therapy for Adult Acute Myelogenous Leukemia (AML)

Study ID: NCT00528398

Conditions

Leukemia

Interventions

cytarabine

idarubicin

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving idarubicin together with high-dose cytarabine works in treating patients with acute myeloid leukemia.

Detailed Description: OBJECTIVES: * Determine the complete remission rate (CR). * Determine the proportion of patients who are bone marrow-positive at day 7 post-induction chemotherapy. * Further evaluate the toxicity of this regimen. OUTLINE: Patients receive cytarabine IV over 3 hours every 12 hours on days 1-4 and idarubicin IV over 5-10 minutes on days 1-3. Patients undergo bone marrow aspirate and biopsy 7 days after completion of induction chemotherapy. Patients with \> 25% cellular biopsy or \> 10% abnormal cells on aspirate receive 4 more doses of cytarabine and 1 dose of idarubicin.