Low-Dose Total-Body Irradiation and Fludarabine Phosphate Followed by Unrelated Donor Stem Cell Transplant in Treating Patients With Fanconi Anemia
Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q)
About this trial
This is an interventional treatment trial for Adult Acute Myeloid Leukemia in Remission
Eligibility Criteria
Inclusion Criteria: Any patient with marrow failure and increased chromosome fragility as determined in the diepoxybutane (DEB) or mitomycin C test Any patient with Fanconi anemia (FA) with marrow failure meeting the following criteria: Granulocyte count < 0.2 x 10^9/L Platelet count < 20 x 10^9/L Hemoglobin < 8 g/dl Corrected reticulocyte count <1% Any patient with FA as determined by DEB fragility, who has life-threatening marrow failure involving a single hematopoietic lineage Any patient with FA and pre-existing cytogenetic abnormality including hematopoietic malignancy (myelodysplastic syndromes [MDS] or acute myeloid leukemia [AML]) in remission DONOR: Unrelated Donors who are prospectively: Matched for human lymphocyte antigen (HLA)-DRB1 and DQB1 alleles (must be defined by high resolution typing); only a single allele disparity will be allowed for HLA -A, B, or C as defined by high resolution typing DONOR: HLA typing will be performed at the highest level of resolution available at the time of transplant Exclusion Criteria: Evidence for hematopoietic malignancy in relapse Heart or lung disease that would prevent compliance with conditioning and GvHD regimen or would severely limit the probability of survival Human immunodeficiency virus (HIV) seropositive patients Females who are pregnant or breastfeeding, or unwilling to use contraceptive techniques during and for the 12 months following treatment DONOR: Donors who by DEB testing are found to have FA DONOR: Donors who test positive in the lymphocytotoxic crossmatch assay DONOR: Donors who are HIV positive DONOR: Donors who for other medical or psychological reasons are not suitable as donors
Sites / Locations
- Robert H. Lurie Comprehensive Cancer Center
- Riley Hospital for Children
- Vanderbilt-Ingram Cancer Center
- Huntsman Cancer Institute/University of Utah
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Arms of the Study
Arm 1
Experimental
Treatment (allogeneic bone marrow or PBSC transplantation)
NON-MYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -4 to -2, cyclosporine IV every 8-12 hours on days -3 to 0, and undergo low-dose TBI on day 0. TRANSPLANTATION: Patients undergo allogeneic bone marrow or PBSC transplantation on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine PO or IV every 8-12 hours on days 1-100 with taper to day 177, and mycophenolate mofetil PO or IV every 8 hours on days 0-40 with taper to day 96.