Phase II Study of High-Dose Busulfan and Cyclophosphamide Followed by Allogeneic Bone Marrow Transplantation for Patients With Acute Myelogenous Leukemia
- Determine the remission duration, disease-free survival, and overall survival of
patients with acute myelogenous leukemia in remission or early relapse or
myelodysplastic syndrome treated with high-dose busulfan and cyclophosphamide followed
by allogeneic bone marrow transplantation.
OUTLINE: Patients receive oral high-dose busulfan every 6 hours for 14-16 doses on days -9
to -6, followed by high-dose cyclophosphamide IV over 1 hour on days -5 to -2. Allogeneic
bone marrow is infused on day 0.
Patients who have already had 1 transplant receive high-dose cyclophosphamide IV on days -6
and -5, total body irradiation twice a day on days -4 to -1, and allogeneic bone marrow
infusion on day 0.
All patients receive prophylaxis for graft versus host disease.
Patients are followed every 6 months for at least 2 years.
PROJECTED ACCRUAL: A total of 25-40 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Martin S. Tallman, MD
Robert H. Lurie Cancer Center
United States: Federal Government
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University
|Chicago, Illinois 60611