Leukemia Clinical Trial
Official title:
Idarubicin and Cladribine in Recurrent and Refractory Acute Myeloid Leukemia: A POG Phase II Study
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 idarubicin and cladribine in treating
children who have recurrent acute myeloid leukemia.
OBJECTIVES:
- Determine the complete response rate in children with primary refractory or recurrent
acute myeloid leukemia (AML) or secondary AML treated with idarubicin and cladribine.
(Refractory AML stratum closed as of 4/3/01) (Secondary AML stratum closed as of
04/02/02)
- Compare the remission reinduction rates in children who relapse at 1 year or earlier vs
more than 1 year from time of initial remission.
- Determine the toxic effects of this regimen in this patient population.
OUTLINE: Patients are stratified according to disease characteristics (primary or secondary
acute myeloid leukemia (AML) with first untreated relapse vs primary refractory AML).
(Refractory AML stratum closed as of 4/3/01) (Secondary AML stratum closed as of 04/02/02)
Patients receive idarubicin IV over 15 minutes on days 1-3, cladribine IV over 2 hours on
days 1-5, and filgrastim (G-CSF) subcutaneously beginning on day 6 and continuing until
blood counts have recovered for 2 days. Treatment repeats every 3 weeks for up to 2 courses
in the absence of disease progression or unacceptable toxicity. Patients who achieve
complete response after completion of course 1 may proceed to other chemotherapy or bone
marrow transplantation at the discretion of the protocol investigator. Patients with
extramedullary disease may receive intrathecal chemotherapy or radiotherapy to symptomatic
sites.
Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then
annually thereafter.
PROJECTED ACCRUAL: A total of 51-102 patients will be accrued for this study within 3 years.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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