Feasibility of Granulocyte-Colony Stimulating Factor (G-CSF) Stimulated Bone Marrow From Pediatric Donors as a Stem Cell Source for Allogeneic Bone Marrow Transplant
- Determine the safety and feasibility of filgrastim (G-CSF)-mobilized bone marrow from
an HLA-identical pediatric sibling donor as a stem cell source for pediatric patients
undergoing allogeneic bone marrow transplantation for malignant or non-malignant
- Determine the time to neutrophil and platelet engraftment, number of red blood cell and
platelet transfusions, number of febrile days, and number of hospitalization days in
patients treated with this regimen.
- Determine the number of nucleated cells and CD34-positive cells, absolute lymphocyte
count, and lymphocyte subsets (CD3/CD4/CD8) in G-CSF-mobilized bone marrow from these
OUTLINE: This is a multicenter, pilot study.
Donors receive filgrastim (G-CSF) subcutaneously once daily on days -4 to 0. Donors then
undergo standard bone marrow harvest on day 0.
Patients receive pre-transplantation conditioning and graft-versus-host disease prophylaxis
according to the disease for which the patient is being treated and the treatment plan or
clinical trial for which the patient is enrolled on. Patients undergo allogeneic bone marrow
transplantation on day 0.
After completion of bone marrow harvest, donors are followed at 7 and 30 days. After
completion of study treatment, patients are followed for 100 days post-transplantation and
then periodically thereafter.
PROJECTED ACCRUAL: A total of 80 participants (40 donors and 40 patients) will be accrued
for this study within 18 months.
Primary Purpose: Treatment
Safety and feasibility
Ann E. Woolfrey, MD
Fred Hutchinson Cancer Research Center
United States: Federal Government
|Fred Hutchinson Cancer Research Center||Seattle, Washington 98109|
|Vanderbilt-Ingram Cancer Center||Nashville, Tennessee 37232-6838|