Phase II Study Evaluating Busulfan and Fludarabine as Preparative Therapy in Adults With Hematopoietic Disorders Undergoing MUD SCT

Inclusion Criteria:

• No fully or single-antigen mismatched sibling donor is available to donate stem cells.
• Age >15 and <61
• ECOG PS < or equal to 2
• Adequate renal function with serum creatinine <2.0 mg/dl
• Pulmonary diffusing capacity >40% of predicted
• Cardiac ejection fraction >40% as measured by radionuclide wall motion study or echocardiography
• No active liver disease. Total bilirubin must be < or equal to 2.0 mg/dl. Alkaline phosphatase and AST must be less than three times the upper limit of normal. Patients with hepatitis C and active hepatitis B are eligible only if a liver biopsy is performed and there is < or equal to grade 2 inflammation. Patients wtih a history of HBV infection should be tested for HBeAg, antiHBe and HBV DNA (quantitative). Patients with active HBV viral replication should receive anti-viral therapy.
• Negative serology for the human immunodeficiency virus (HIV)
• Available HLA-matched donor (see HLA compatibility requirements below)
• Signed informed consent from the recipient

Exclusion Criteria:

• Ongoing active infection
• Pregnancy and/or nursing
• Active, uncontrolled CNS leukemia
• Opinion of BMT Committee that autologous or mini-allogeneic transplant would be the preferable form of treatment
• Receipt of any chemotherapy within 3 weeks of study entry except for hydroxyurea or imatinib mesylate. Use of interferon within 3 months of starting therapy.