A Phase II Study of Gemtuzumab Ozogamicin (Mylotarg™) and Standard Dose Ara-C for Patients With Relapsed Acute Myeloid Leukemia (AML)

Pts must have morphologically confirmed diagnosis of relapsed AML with FAB classification other than M3. Relapse should be demonstrated by the presence of greater than 5% blasts in the bone marrow or reappearance of greater than 5% leukemic blasts in the peripheral blood. Pts with M3 AML or blastic transformation of CML are not eligible. Pts with prior MDS or secondary AML are eligible. Pts must be in first relapse from documented CR. Pts must not have received prior Mylotarg™ for acute leukemia. Pts relapsing after autologous or allogeneic hematopoietic stem-cell transplant are not eligible. Administration of hydroxurea to control high cell counts is permitted prior to registration. Prior treatment with other investigational agents is permitted; however, 28 days must have elapsed from prior tx and all toxicities must have resolved. Pts must be CD33 positive. This study must be performed within 14 days prior to registration. Pts must be at least 18 yrs. of age. Pts must have a Zubrod PS of 0-2. Pts must have a bilirubin less than or equal to 1.5 x IULN. Pts must also have SGOT or SGPT less than or equal to 1.5 x IULN. Studies must be done within 14 days prior to registration. Pts must have a WBC less than or equal to 30,000/µl performed within 14 days prior to registration. Pts must not have clinical or documented CNS involvement with AML. Pts with unstable cardiac arrhythmias or unstable angina are not eligible. Pts must not be known to be HIV positive prior to registration. Pre-tx pathology materials must be submitted for morphologic review as described in the protocol. Pts must be registered on SWOG-9007, the cytogenetics protocol. Pts must not be pregnant or nursing. Pts must have agreed to use an effective contraceptive method. No other prior malignancy is allowed except: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the pt is currently in remission, or any other cancer from which the pt has been disease-free for 5 yrs.