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
- 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
- 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
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
John Pagel, MD, PhD
Fred Hutchinson Cancer Research Center
United States: Federal Government
|Fred Hutchinson Cancer Research Center||Seattle, Washington 98109|