Phase II Study Evaluating Busulfan and Fludarabine as Preparative Therapy in Adults With Hematopoietic Disorders Undergoing Matched Unrelated Donor Stem Cell Transplantation
- No fully or single-antigen mismatched sibling donor is available to donate stem
- 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
- 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
- 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.