Radiolabeled BC8 Antibody, Busulfan, Cyclophosphamide Followed by Donor Stem Cell Transplant in Treating Patients With Acute Myelogenous Leukemia in First Remission
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: Patients with AML in first remission Creatinine < 2.0 mg/dl Bilirubin < 1.5 mg/dl which is expected to exclude patients at high risk of developing veno-occlusive disease of the liver Aspartate aminotransferase (AST) < 1.5 times the upper limit of normal which is expected to exclude patients at high risk of developing veno-occlusive disease of the liver Patients must have an expected survival of > 60 days and must be free of major infection DONOR: genotypic or phenotypic HLA-matched family members; related donors should be matched by molecular methods at the intermediate resolution level at HLA-A, B, C, and DR beta 1 (DRB1) according to Fred Hutchinson Cancer Research Center (FHCRC) Standard Practice Guidelines and to the allele level at DQ beta 1 (DQB1) Exclusion Criteria: Patients with history of or current leukemic involvement of the central nervous system (CNS) Prior radiation to maximally tolerated levels to any normal organ Inability to understand or give an informed consent Patients who are seropositive for human immunodeficiency virus (HIV) Perceived inability to tolerate diagnostic or therapeutic procedures, particularly treatment in radiation isolation Circulating antibody against mouse immunoglobulin DONOR: unrelated donors and donors mismatched for 1 or more HLA antigens DONOR: donors who for psychologic, physiologic or medical reasons are unable to undergo filgrastim (G-CSF)- mobilized PBSC collection or marrow harvesting DONOR: donors who are seropositive for HIV
Sites / Locations
- Pacific Northwest National Laboratory
- VA Puget Sound Health Care System
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Arms of the Study
Arm 1
Experimental
Treatment (radiolabeled BC8, chemotherapy, PBSCT)
RADIOLABELED ANTIBODY: Patients receive iodine I 131 monoclonal antibody BC8 IV on day -13. CHEMOTHERAPY: Patients receive busulfan PO every 6 hours on days -7 to -4 and cyclophosphamide IV on days -3 and -2. TRANSPLANT: Patients undergo allogeneic PBSC or BM transplant on day 0. GRAFT-VS-HOST DISEASE PREVENTION: Patients receive cyclosporine IV or PO every 12 hours on days -1 to 50 with a taper to day 180. Patients also receive methotrexate IV on days 1, 3, 6, and 11.