A Phase 2, Controlled Trial, Of A Single Prohema-CB Unit (Ex Vivo CXCR4-Upregulated CD34+ Hematopoietic Progenitor Cells, Cord Blood) As Part Of A Double Umbilical Cord Blood Transplant Following Myeloablative Conditioning For Patients Age 15-55 Years With Hematologic Malignancies
All subjects will receive a myeloablative conditioning regimen, after which they will
receive 2 HLA-matched UCB units. A total of 30 subjects will receive one ProHema-CB as part
of a double CB transplant and an additional 15 subjects will be enrolled as concurrent
controls. The determination of which CB unit will be the ProHema-CB unit will be made based
primarily upon the degree of HLA match.
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Neutrophil engraftment/chimerism
To determine the rate of neutrophil engraftment by Day 26 after a single ProHema-CB unit is used as part of a double CB transplant following myeloablative conditioning for subjects age 15-55 years with hematologic malignancies.
Day 26
No
Pratik Multani, MD
Study Director
Fate Therapeutics
United States: Food and Drug Administration
FT1050-03
NCT01627314
July 2012
December 2014
Name | Location |
---|---|
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
City of Hope | Duarte, California 91010 |
Oregon Health Sciences | Portland, Oregon 97201 |
Mount Sinai Hospital | New York, New York 10029 |
Ohio State University Comprehensive Cancer Center | Columbus, Ohio |
Dana-Farber Cancer Institute- Hematopoietic Stem Cell Transplant Program | Boston, Massachusetts 02215 |