Leukemia Clinical Trial
Official title:
RADIOLABELED BC8 (ANTI-CD45) ANTIBODY COMBINED WITH BUSULFAN AND CYCLOPHOSPHAMIDE AS TREATMENT FOR ACUTE MYELOGENOUS LEUKEMIA IN FIRST OR SECOND REMISSION OR UNTREATED FIRST RELAPSE FOLLOWED BY HLA-IDENTICAL RELATED MARROW TRANSPLANTATION
RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver
cancer-killing substances to them without harming normal cells. Monoclonal antibody combined
with a radioactive substance and given prior to bone marrow transplantation may kill more
cancer cells.
PURPOSE: Phase II trial to study the effectiveness of radiolabeled monoclonal antibody given
prior to bone marrow transplantation in treating patients with acute myelogenous leukemia.
OBJECTIVES: I. Determine the overall and disease-free survival and toxicity associated with
busulfan/cyclophosphamide (BU/CTX) plus 131I-labeled BC8 antibody (131I-BC8) followed by an
HLA-identical related marrow transplant in patients with acute myelogenous leukemia in first
or second remission or untreated first relapse. II. Study factors that may influence the
biodistribution of 131I-BC8 in this patient population, including marrow cellularity, the
level of antigen expression by leukemic cells (in relapsed patients), and the degree of
antigen saturation by antibody. III. Determine the efficacy of BU/CTX in patients in first
remission unable to receive radiolabeled antibody, e.g., patients who are HAMA-positive,
those not tolerating antibody test infusion, those with unfavorable antibody
biodistribution, or those for whom antibody is unavailable.
OUTLINE: Radioimmunotherapy plus 2-Drug Cytoreductive Chemotherapy followed by Bone Marrow
Transplantation with, as indicated, CNS Therapy. Iodine-131-labeled Monoclonal Antibody BC8
(anti-CD45), 131I-BC8; plus Busulfan, BU, NSC-750; Cyclophosphamide, CTX, NSC-26271;
followed by Allogeneic Bone Marrow, ABM; with, as indicated, Intrathecal Methotrexate, IT
MTX, NSC-740.
PROJECTED ACCRUAL: It is anticipated that 30 patients in first remission, 30 patients in
untreated first relapse, and 15 patients in second remission will be accrued over 3 years.
;
Primary Purpose: Treatment
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