Leukemia Clinical Trial
Official title:
PHASE II STUDY OF HIGH DOSE CYTARABINE COMBINED WITH A SINGLE HIGH DOSE OF IDARUBICIN FOR NEWLY DIAGNOSED PATIENTS WITH AML: THE AML-3 PROTOCOL
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 high-dose cytarabine plus idarubicin
in treating patients with newly diagnosed acute or chronic myelogenous leukemia or
myelodysplastic syndrome.
OBJECTIVES: I. Evaluate the effect of combined intensive induction and postremission therapy
with high-dose cytarabine plus a single high dose of idarubicin in patients with previously
untreated acute myelogenous leukemia (AML). II. Identify cytogenetic, molecular, or
immunophenotypic markers in AML patients for use in the study of residual disease.
OUTLINE: All patients receive high dose cytarabine for 5 days and idarubicin on the third
day as induction chemotherapy. Patients who achieve a complete remission (CR) proceed to
consolidation chemotherapy, as follows: cytarabine and etoposide for 5 days; and, for
patients aged 60 and under, cytarabine for 4 days, with idarubicin on the third day.
Patients eligible for the second consolidation course may have peripheral blood stem cells
collected following this regimen. Patients with an HLA-compatible donor then proceed to
allogeneic bone marrow transplantation, while patients over age 60, those with the t(8;21)
or inv16 cytogenetic abnormality, and those without an HLA-compatible donor receive
maintenance therapy with the humanized monoclonal antibody M195 twice weekly for 3 weeks,
then monthly for 5 months. G-CSF is administered with each chemotherapy regimen. Patients
are followed for survival.
PROJECTED ACCRUAL: 60 patients will be entered over 3 years.
;
Primary Purpose: Treatment
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