A Phase I Trial Of Total Body Irradiation, Cyclophosphamide Dose-Adjustment Based On Its Metabolism, And Hematopoietic Stem Cell Transplantation For Patients With Hematological Malignancy
- Determine a safe and reproducible method of adjusting the dose of cyclophosphamide
based on its metabolism when given in combination with total body irradiation and
hematopoietic stem cell transplantation in patients with hematologic malignancy.
- Preparative regimen: Patients undergo total body irradiation twice daily on days -6 to
-4. Patients then receive dose-adjusted (based on metabolism) cyclophosphamide IV over
1 hour on days -3 and -2.
- Hematopoietic stem cell (HSC) infusion: Patients undergo allogeneic HSC transplantation
on day 0.
Patients receive graft-versus-host disease prophylaxis, CNS prophylaxis, and testicular
irradiation as per institutional standard practices.
Patients are followed daily until day 80 after transplantation and then regularly thereafter
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
George B. McDonald, MD
Fred Hutchinson Cancer Research Center
United States: Federal Government
|Fred Hutchinson Cancer Research Center||Seattle, Washington 98109|