A Phase II Trial to Evaluate the Use of G-CSF-Mobilized Peripheral Blood Progenitor Cells as Hematopoietic Rescue in Patients With Acute Leukemia Undergoing Allografting From an Unrelated Donor
- Determine whether filgrastim (G-CSF)-mobilized allogeneic peripheral blood stem cell
transplantation reduces the incidence of non-leukemic mortality in patients with acute
- Determine the kinetics and durability of engraftment after treatment with this regimen
in these patients.
- Determine the incidence and severity of acute and chronic graft-versus-host disease in
patients treated with this regimen.
- Determine the leukemia-free survival of patients treated with this regimen.
OUTLINE: Donors receive filgrastim (G-CSF) subcutaneously (SC) on days -5 to -1. Donors then
undergo leukapheresis on days -1 and 0.
Patients undergo total body irradiation twice daily on days -7 to -4. Patients receive 2
doses of intrathecal methotrexate per local guidelines between days -10 and -3. Patients
also receive cyclophosphamide IV on days -3 and -2. Patients receive infusion of allogeneic
peripheral blood stem cells on day 0.
PROJECTED ACCRUAL: A total of 5-60 patients will be accrued for this study within 3 years.
Masking: Open Label, Primary Purpose: Treatment
Claudio Anasetti, MD
Fred Hutchinson Cancer Research Center
United States: Federal Government
|Fred Hutchinson Cancer Research Center||Seattle, Washington 98109|