Leukemia Clinical Trial
Official title:
A Phase II Study Of Daunomycin And ARA-C, Both Given By Continous IV Infusion For Previously Untreated Non-M3 Acute Myeloid Leukemia (AML) In Patients Of Age 56 Or Older
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combining cytarabine and daunorubicin
in treating older patients who have acute myeloid leukemia that has not been previously
treated.
OBJECTIVES:
- Determine the efficacy of cytarabine and daunorubicin as induction chemotherapy in
older patients with previously untreated non-M3 acute myeloid leukemia.
- Determine the frequency and severity of toxic effects of this regimen in these
patients.
OUTLINE: This is a multicenter study.
Patients receive induction chemotherapy comprising daunorubicin IV continuously over days
1-3 and cytarabine IV continuously over days 1-7. Patients may be treated with a second
course of induction chemotherapy beginning on day 19 if remission is not achieved at that
time. Patients also receive filgrastim (G-CSF) or sargramostim (GM-CSF) IV or subcutaneously
daily beginning on day 15 and continuing until blood counts recover.
Patients who achieve remission after the first or second course of induction chemotherapy
receive consolidation chemotherapy comprising daunorubicin IV continuously over days 1 and 2
and cytarabine IV continuously over days 1-5. Beginning no earlier than day 19, patients
receive a second course of consolidation chemotherapy.
Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then
annually for 3 years.
PROJECTED ACCRUAL: Approximately 30-55 patients will be accrued for this study within 8-9
months.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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