Trial Information

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

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.