A Randomized Trial of Maintenance versus Observation for Patients with Previously Untreated Low and Intermediate Risk Acute Promyelocytic Leukemia (APL), Phase III

Morphologically confirmed diagnosis of low or intermediate risk APL, or the variant form of APL, based on BM done within 14 days before reg. WBC and plt confirming low or intermediate risk must be done within 48 hours before reg, unless pt received ATRA before reg, in which case counts must be done within 48 hours before ATRA started. Pts known to be PML-RARalpha negative are not eligible. No recurrent disease. Zubrod 0-3. 18 years of age or older. No unstable cardiac arrhythmias or angina. Must not have received systemic chemo, hydroxyurea, or leukapheresis for acute leukemia, except ATRA at a dose of </= 45 mg/m2/day for </= 5 days before reg is permitted. Must not have received more than one dose of intrathecal chemo for acute leukemia. No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer (excluding pts with highly aggressive malignancies with a high rate of early relapse) from which the pt is currently in complete remission, or any other cancer from which the pt has been disease-free for 5 years. SWOG pts must be registered on SWOG-9007 and S9910. CALGB pts must be registered on CALGB 8461 and CALGB 9862. ECOG pts must be registered on E3903 (if open at site) or submit baseline/follow-up karyotypes (if not open at site). Pts must not be pregnant or nursing.