Idarubicin and High-Dose Cytarabine in Treating Patients With Acute Myeloid Leukemia
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial Utilizing Idarubicin in Combination With High Dose Ara-C for Induction Therapy for Adult Acute Myelogenous Leukemia (AML)|
- Complete remission (CR) rate [ Time Frame: Up to 20 years ] [ Designated as safety issue: No ]
|Study Start Date:||September 1994|
|Estimated Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
Experimental: Treatment (idarubicin, cytarabine)
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.
|Drug: cytarabine Drug: idarubicin|
- Determine the complete remission rate (CR), and compare this rate to the historical control group rate of 79% from our previous study achieved utilizing high-dose cytarabine and daunorubicin.
- Determine the proportion of patients who are bone marrow-positive at day 7 post-induction chemotherapy, and compare this rate to the historical control group rate of 20%.
- Determine the ability of patients treated with this regimen to receive further post-remission chemotherapy, and compare this rate to historical control group rate of 81% among 79 patients achieving CR in our previous study.
- Further evaluate the toxicity of this regimen, and contrast this with our previous study results.
- Determine the effect of prognostic variables on achieving a complete remission (e.g., age, WBC, FAB type, cytogenetics, and CD34).
- Describe the CR rate, proportion of patients whose bone marrow is positive at day 7 post-induction chemotherapy, ability to receive further post-remission chemotherapy, and toxicity in 2 subgroups of patients (patients with prior myelodysplastic syndrome and patients with treatment-related leukemia).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00528398
|United States, Arizona|
|Banner Good Samaritan Medical Center|
|Phoenix, Arizona, United States, 85006|
|United States, California|
|City of Hope Comprehensive Cancer Center|
|Duarte, California, United States, 91010-3000|
|Principal Investigator:||Anthony S. Stein, MD||Beckman Research Institute|