Treatment of Acute Myelogenous Leukemia With Busulfan and Etoposide Followed by Autologous or Syngeneic Stem Cell Rescue and Low-Dose Interleukin 2 (IL-2) Immunotherapy
I. To evaluate the toxicity and overall survival of high dose Bu (busulfan)/VP-16
(etoposide) followed by post-transplant low-dose interleukin (IL)-2 (aldesleukin) in
patients with AML.
I. To estimate the rate of relapse associated with this regimen.
PREPARATIVE REGIMEN: Patients receive busulfan intravenously (IV) over 2 hours or orally
(PO) every 6 hours on days -7 to -4 and etoposide IV on day -3.
STEM CELL INFUSION: Patients undergo autologous or syngeneic PBSC rescue on day 0.
POST-TRANSPLANT ALDESLEUKIN THERAPY: Beginning 30-100 days after transplant, patients
receive high-dose aldesleukin subcutaneously (SC) daily for 12 weeks.
After completion of study treatment, patients are followed up every 3 months for 2 years,
every 6 months for 3 years, and then annually thereafter.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall survival of patients on busulfan and etoposide followed by stem cell rescue and aldesleukin
Estimated by the method of Kaplan and Meier.
At 3 years
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Food and Drug Administration
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|