Multicenter Phase II Study of Radiolabled BC8 (Anti-CD45) Antibody Combined With Busulfan and Cyclophosphamide as Treatment for Acute Myelogenous Leukemia in First Remission Followed by HLA-identical Related Marrow Transplantation
16 Years
55 Years
Both
Leukemia
Trial Information
Multicenter Phase II Study of Radiolabled BC8 (Anti-CD45) Antibody Combined With Busulfan and Cyclophosphamide as Treatment for Acute Myelogenous Leukemia in First Remission Followed by HLA-identical Related Marrow Transplantation
OBJECTIVES:
- Determine the disease-free and overall survival of patients with acute myelogenous
leukemia in first remission treated with busulfan and cyclophosphamide plus iodine I
131 monoclonal antibody BC8 followed by HLA identical related bone marrow
transplantation.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive a test dose of iodine I 131 monoclonal antibody BC8 (I131 MOAB BC8) IV,
then about 2 weeks later, on day -13, a therapeutic dose of I131 MOAB BC8 IV is
administered. Patients then receive oral busulfan every 6 hours on days -7 to -4 (16 doses)
and cyclophosphamide IV on days -3 and -2. Donor bone marrow is infused on day 0.
Patients are followed at 6, 9, and 12 months, then every 6 months for 1 year, then annually
thereafter.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Acute myelogenous leukemia in first remission
- No prior or concurrent CNS involvement by leukemia
- Genotypically or phenotypically HLA matched family member available as donor
PATIENT CHARACTERISTICS:
Age
- 16 to 55
Performance status
- Not specified
Life expectancy
- More than 60 days
Hematopoietic
- Not specified
Hepatic
- Bilirubin less than 1.5 mg/dL
- AST no greater than 1.5 times upper limit of normal
- No current hepatitis
- No high risk for developing veno-occlusive disease of the liver
Renal
- Creatinine less than 2.0 mg/dL
Other
- HIV negative
- No major infection
- No perceived inability to tolerate study procedures, particularly treatment in
radiation isolation
- No circulating antibody to mouse immunoglobulin
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- No prior radiotherapy to maximum tolerated levels to any normal organ
Surgery
- Not specified
Type of Study:
Interventional
Study Design:
Masking: Open Label, 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:
1470.00
NCT ID:
NCT00005940
Start Date:
October 1999
Completion Date:
December 2003
Related Keywords:
- Leukemia
- adult acute myeloid leukemia in remission
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
Name | Location |
|---|---|
| Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
