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
16 Years
55 Years
Both
Leukemia
Trial Information
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
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.
Inclusion Criteria
DISEASE CHARACTERISTICS: Acute myelogenous leukemia in first or second remission or
untreated first relapse Documented CD45 expression by leukemic cells required for patients
in relapse Phenotyping not required for patients in remission; such patients may have
leukemia previously documented to be CD45 negative Circulating blast count less than
10,000 (control with hydroxyurea or similar agent allowed) Genotypically or phenotypically
HLA-matched related marrow donor required No donors mismatched for 1 or more HLA antigens
No psychologic, physiologic, or medical contraindication to donation No high risk for
anesthesia because of age or medical problems No HIV seropositive donors
PATIENT CHARACTERISTICS: Age: 16 to 55 Performance status: Not specified Life expectancy:
Greater than 60 days Hematopoietic: Not applicable Hepatic: Bilirubin less than 1.5 mg/dl
No risk of developing veno-occlusive disease of the liver (i.e., current evidence of
hepatitis as manifested by SGOT greater than 1.5 x ULN) Renal: Creatinine less than 2.0
mg/dl Other: No HIV seropositivity No major infection
PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior radiotherapy to maximally
tolerated levels for any normal organ
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
John Pagel, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Fred Hutchinson Cancer Research Center
Authority:
United States: Federal Government
Study ID:
832.00
NCT ID:
NCT00002554
Start Date:
November 1993
Completion Date:
December 1999
Related Keywords:
- Leukemia
- recurrent adult acute myeloid leukemia
- adult acute myeloid leukemia in remission
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
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