Leukemia Clinical Trial
Official title:
Phase II Trial Utilizing Idarubicin in Combination With High Dose Ara-C for Induction Therapy for Adult Acute Myelogenous Leukemia (AML)
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.
OBJECTIVES:
- 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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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