A Phase II Trial of Total Body Irradiation Plus Metabolism-Based Cyclophosphamide Dosing as Preparative Therapy for Allogeneic Hematopoietic Cell Transplant for Patients With Hematological Malignancy
- Evaluate the potential efficacy of targeting cyclophosphamide to a metabolic endpoint
when given together with total-body irradiation, in terms of day 200 nonrelapse
mortality, in patients with hematologic cancer and other diseases who are undergoing
allogeneic hematopoietic stem cell transplantation.
- Determine the overall survival of patients treated with this regimen.
- Determine the rate of relapse in patients treated with this regimen.
- Determine the occurrence of sinusoidal obstruction syndrome in patients treated with
- Determine the occurrence of acute renal failure in these patients.
- Determine the occurrence of respiratory failure in these patients.
- Conditioning regimen: Patients undergo total-body irradiation twice daily on days -6 to
-4. Patients also receive cyclophosphamide IV over 1 hour on day -3 and then IV at a
metabolism-based dose* on day -2.
NOTE: *Patients undergo frequent blood sampling after completion of the first
cyclophosphamide infusion for pharmacokinetic studies in order to determine the dose for the
second cyclophosphamide infusion.
- Allogeneic stem cell transplantation: Patients undergo allogeneic bone marrow or
peripheral blood stem cell transplantation on day 0.
- Graft-versus-host disease (GVHD) prophylaxis: Patients receive GVHD prophylaxis as per
the attending physician, including one of the following regimens: cyclosporine and
methotrexate; tacrolimus and methotrexate; tacrolimus and mycophenolate mofetil; or
sirolimus, tacrolimus, and methotrexate (as per the GVHD prophylaxis regimen chosen for
After completion of study treatment, patients are followed periodically for at least 200
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Non-relapse mortality (NRM) at 200 days
George B. McDonald, MD
Fred Hutchinson Cancer Research Center
United States: Federal Government
|Fred Hutchinson Cancer Research Center||Seattle, Washington 98109|
|Seattle Cancer Care Alliance||Seattle, Washington 98109|