Combination Chemotherapy With or Without Valspodar in Treating Patients With Previously Untreated Acute Myeloid Leukemia
Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Minimally Differentiated Myeloid Leukemia (M0), Adult Acute Monoblastic Leukemia (M5a)
About this trial
This is an interventional treatment trial for Adult Acute Megakaryoblastic Leukemia (M7)
Eligibility Criteria
Inclusion Criteria: Unequivocal histologic diagnosis of AML, FAB classification (M0-M7), excluding M3 (acute promyelocytic leukemia); patients with a history of antecedent myelodysplasia remain eligible for treatment on this trial No prior treatment for acute leukemia or myelodysplasia with four permissible exceptions: Emergency leukapheresis; Emergency treatment for hyperleukocytosis with hyroxyurea; Cranial RT for CNS leukostasis (one dose only); Growth factor/cytokine support.
Sites / Locations
- Cancer and Leukemia Group B
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm I (cytarabine, daunorubicin, etoposide)
Arm II (valspodar, daunorubicin, etoposide, cytarabine)
Patients receive cytarabine IV continuously over 7 days and daunorubicin IV bolus followed by etoposide IV over 2 hours on days 1-3.
Patients receive treatment as in arm I with the addition of PSC 833 induction. A loading dose of PSC 833 IV is given over 2 hours, followed by a 74-hour continuous infusion of PSC 833 beginning 2 hours before daunorubicin and etoposide. Patients may receive a second induction course if residual leukemia is present in the bone marrow. Patients who experience a CR and meet certain other criteria receive postremission chemotherapy consisting of cytarabine IV continuously over 5 days plus daunorubicin IV followed by etoposide IV over 2 hours on days 1 and 2. Patients who are randomized to receive PSC 833 during induction chemotherapy receive a loading dose of PSC 833 before beginning a 48-hour continuous infusion of PSC 833 concurrently with cytarabine/daunorubicin/etoposide postremission chemotherapy. After completing postremission chemotherapy, patients are randomized to a no further treatment group or IL-2 immunotherapy.