The links after "Participants" show which Southwest Oncology Group institutions are eligible to participate in this study.

The orange "Where is This Study Open?" tab at the bottom of the page shows the institutions whose Institutional Review Boards (IRBs) have approved the protocol so that it can be opened at that institution. Clicking on the Institution Name will show the points of contact for information about this study at that institution.

Status Notes: This study will close permanently to accrual effective December 15, 2006.

Disease Committee: Leukemia

Participants: Members, CCOP, Medical Oncologists, Pathologists

Eligibility Criteria: Initial Registration: Pts must have a morphologically confirmed diagnosis of AML with FAB classification other than M3, based on bone marrow and biopsy performed within 14 days prior to registration. Pts with M3 AML or blastic transformation of CML are not eligible. Pts must have reached their 56th birthday. Pts must have a Zubrod PS of 0-3 if less than age 61, Zubrod PS of 0-2 if age 61-70, and Zubrod PS of 0-1 if age 71 or older. Pts must have a bilirubin less than or equal to 2 x IULN, within 7 days prior to this registration, unless the elevation is due primarily to elevated unconjugated hyperbilirubinemia secondary to Gilbert's syndrome or hemolysis, and not to liver dysfunction. Pts must also have SGOT (AST) less than or equal to 4 x IULN, or SGPT (ALT) less than or equal to 4 x IULN, within 7 days prior to this registration. Serum creatinine less than or equal to 1.5 x IULN or a creatinine clearance greater than 40 cc/min, or both. Pts must have a normal left ventricular function with an ejection fraction greater than or equal to 50% as measured by MUGA scan or 2-D ECHO. Pts with unstable cardiac arrhythmias or unstable angina are not eligible. Pts must not have received prior systemic chemotherapy for acute leukemia. Administration of hydroxyurea to control high cell counts prior to registration is permitted. A history of prior treatment of MDS with low dose cytosine arabinoside or with azacitidine is permitted; however, 30 days must have elapsed from prior treatment and all toxicities resolved. If indicated, a single dose of intrathecal chemotherapy may also be given before or concurrent with induction chemotherapy. Pts must be registered on SWOG-9007 and on S9910. Pts must agree to submit blood and plasma for PK studies per the protocol. Pts must not be pregnant or nursing. Women/men of reproductive potential must have agreed to use an effective contraceptive method. No other prior malignancy is allowed except for the following: 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 complete remission, or any other cancer from which the pt has been disease-free for 5 years.