Radiolabeled BC8 Antibody, Busulfan, Cyclophosphamide Followed by Donor Stem Cell Transplant in Treating Patients With Acute Myelogenous Leukemia in First Remission

PRIMARY OBJECTIVES:

I. To determine the efficacy (as measured by survival and disease-free survival) and
toxicity of a regimen of busulfan 16 mg/kg and cyclophosphamide 120 mg/kg plus 131I-labeled
anti-cluster of differentiation (CD) 45 antibody (iodine I 131 monoclonal antibody BC8)
(delivering a dose of 5.25 gray [Gy] to the normal organ receiving the highest dose) in
patients with acute myeloid leukemia (AML) in first remission receiving human leukocyte
antigen (HLA)-identical related peripheral blood stem cell (PBSC) transplants.

OUTLINE:

RADIOLABELED ANTIBODY: Patients receive iodine I 131 monoclonal antibody BC8 intravenously
(IV) on day -13.

CHEMOTHERAPY: Patients receive busulfan orally (PO) every 6 hours on days -7 to -4 and
cyclophosphamide IV on days -3 and -2.

TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow (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.

After completion of study treatment, patients are followed up at 6, 9, and 12 months; every
6 months for 1 year; and then yearly thereafter.

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