A Phase II Study Evaluating the Safety and Efficacy of Subcutaneous Plerixafor for the Mobilization and Transplantation of HLA-Matched Sibling Donor Hematopoietic Stem Cells in Recipients With Hematological Malignancies
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The proportion of donors whose cells can be successfully mobilized and collected with a sufficient CD34+ cell dose using plerixafor as the mobilizing agent, using an intention-to-treat analysis
To determine the proportion of donors whose cells can be successfully mobilized and collected with a sufficient CD34+ cell dose using plerixafor as the mobilizing agent, using an intention-to-treat analysis. Donor mobilization following plerixafor will be considered successful if ≥ 2.0x106 CD34+ cells/kg recipient weight are collected in no more than two leukapheresis collections. All donors receiving plerixafor will be included in the analysis of the primary objective based on the intention-to-treat principle.
donation
No
Steve Devine, MD
Principal Investigator
Ohio State University
United States: Food and Drug Administration
09-PLEX
NCT01696461
May 2013
September 2016
Name | Location |
---|---|
Mayo Clinic | Rochester, Minnesota 55905 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
University of Minnesota | Minneapolis, Minnesota 55455 |
Duke University | Durham, North Carolina 27710 |
H. Lee Moffitt Cancer Center | Tampa, Florida 33612 |
Emory University | Atlanta, Georgia 30322 |
Cleveland Clinic | Cleveland, Ohio 44195 |
Ohio State University | Columbus, Ohio 43210 |
University of Chicago | Chicago, Illinois 60637 |
Washington University | St. Louis, Missouri 63110 |
West Virginia University | Morgantown, West Virginia 26506 |