Monoclonal Antibody Therapy Plus Combination Chemotherapy and Bone Marrow Transplantation in Treating Patients With Acute Myelogenous Leukemia
RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells.
PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy plus combination chemotherapy and bone marrow transplantation in treating patients who have acute myelogenous leukemia.
Procedure: allogeneic bone marrow transplantation
Radiation: iodine I 131 monoclonal antibody BC8
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
|Study Start Date:||October 1999|
|Study Completion Date:||December 2003|
|Primary Completion Date:||December 2003 (Final data collection date for primary outcome measure)|
- 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.
|United States, Washington|
|Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 98109-1024|
|Study Chair:||John Pagel, MD, PhD||Fred Hutchinson Cancer Research Center|