Phase I/II Study of Total Body Irradiation, Cyclophosphamide, and Fludarabine Followed by Alternate Donor Hematopoietic Cell Transplantation in Patients With Fanconi's Anemia

Inclusion Criteria

• •PROTOCOL ENTRY CRITERIA:
• •-Disease Characteristics--
• •Patients with a diagnosis of Fanconi's anemia AND Aplastic anemia OR Myelodysplastic syndrome OR Acute leukemia with or without chromosomal anomalies Aplastic anemia as defined by having at least one of the following: Platelet count less than 20,000/mm3 Absolute neutrophil count less than 500/mm3 Hemoglobin less than 8 g/dL
• •Myelodysplastic syndrome with multilineage dysplasia With or without chromosomal anomalies
• •Hematologic malignancy (e.g., acute myeloid leukemia, acute lymphoblastic leukemia, or B-cell non-Hodgkin's lymphoma)
• •No greater than 30% blasts in bone marrow or greater than 5% blasts in peripheral blood
• •No active CNS leukemia at time of transplantation
• •Must have an HLA A, B, DRB1 identical or 1 antigen mismatched related (nonsibling) or unrelated bone marrow, peripheral blood, or umbilical cord blood donor
• •-Prior/Concurrent Therapy--
• •Radiotherapy: No prior radiotherapy that would preclude total body irradiation
• •Surgery: Not specified
• •-Patient Characteristics--
• •Performance status: Karnofsky 70-100% OR Lansky 50-100%
• •Hematopoietic: See Disease Characteristics
• •Hepatic: No hepatic failure (e.g., coagulopathy or ascites)
• •Renal: Creatinine clearance at least 40 mL/min
• •Cardiovascular: Ejection fraction at least 45%
• •Other: No active uncontrolled infection within one week of transplantation No malignant solid tumor (e.g., squamous cell carcinoma of the head, neck, or cervix) within 2 years of transplantation Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception