A Pilot Study of Combined Plerixafor + Filgrastim for Mobilization of Peripheral Blood Stem Cells From Normal Donors
I. The percentage of normal donors who collect at least 2 x 10^6 CD34 cells/kg recipient
weight on day 1 after administration of combined filgrastim and plerixafor.
I. Measuring CD34+ cells/ul in peripheral blood of donors 11, 15, 24 and 36 hours post
II. Tolerance and safety of combined filgrastim and Plerixafor in normal donors.
III. Engraftment of filgrastim/plerixafor mobilized stem cells in allogeneic recipients.
IV. Acute and chronic graft-versus-host disease (GVHD) following the use of
filgrastim/plerixafor mobilized stem cells.
V. Yield of CD34+ cells based on donor weight.
OUTLINE: Donors receive filgrastim subcutaneously (SC) and plerixafor SC on day -14 and
undergo leukapheresis to collect peripheral blood stem cells (PBSC) on day -13. These cells
are frozen to preserve them. Treatment modifications may apply according to sufficient
collection of PBSC. Patients receive standard high-dose conditioning and undergo allogeneic
PBSC transplantation on day 0 using the previously frozen cells.
After completion of study treatment, donors are followed up 1 day after the last stem cell
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Percentage of donors collecting at least 2 x 10^6 CD34+ cells based on actual recipient body weight
Day after collection
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Food and Drug Administration
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|