Use Of Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) To Mobilize Donor Peripheral Blood Stem Cells Along With GM-CSF Administration Post Allogeneic Transplant - A Pilot Study
- Determine the efficacy of sargramostim (GM-CSF) to mobilize CD34+ hematopoietic stem
cells in donors and to reduce graft-vs-host disease in patients after allogeneic stem
cell transplantation (SCT) for hematologic malignancy or aplastic anemia.
- Determine the safety of GM-CSF after allogeneic SCT transplantation in these patients.
OUTLINE: This is a pilot study.
- Donors: Donors receive sargramostim (GM-CSF) subcutaneously (SC) once daily on days
1-6. Donors undergo stem cell harvest on day 7.
Donors may undergo up to 3 apheresis procedures to reach the target stem cell dose and may
receive additional GM-CSF prior to each collection.
- Patients: Patients receive conditioning therapy as per transplantation protocol
RP98-15. Patients undergo allogeneic stem cell transplantation on day 0. Patients then
receive GM-CSF SC once daily beginning on day 7 and continuing until blood counts
Patients are followed weekly until day 100 and then at days 180 and 360.
PROJECTED ACCRUAL: A total of 10 patients and 10 donors will be accrued for this study.
Primary Purpose: Supportive Care
Philip L. McCarthy, MD
Roswell Park Cancer Institute
United States: Federal Government
|Roswell Park Cancer Institute||Buffalo, New York 14263|