This study is an open-label randomized, prospectively and historically controlled trial of the safety and efficacy of a single ProHema-CB unit used as part of a double CB transplant following myeloablative or reduced intensity conditioning for subjects age 15-65 years with hematologic malignancies. A maximum of 60 eligible subjects will be enrolled and treated in the trial at approximately 10 centers within the U.S.
All subjects will receive a myeloablative or reduced intensity conditioning regimen, after which they will receive 2 Human Leukocyte Antigen (HLA)-matched or partially matched umbilical cord blood (UCB) units. A total of 40 subjects will receive one ProHema-CB as part of a double CB transplant and an additional 20 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
62
Ex-vivo CXCR4 upregulated hematopoietic progenitor cells, cord blood
Cord Blood
City of Hope
Duarte, California, United States
Emory University-Winship Cancer Institute
Atlanta, Georgia, United States
Loyola University Medical Center
Maywood, Illinois, United States
Rate of early neutrophil engraftment using Myeloablative Conditioning
To determine the rate of neutrophil engraftment after a single ProHema-CB unit is used as part of a double CB transplant following myeloablative conditioning for subjects with hematologic malignancies.
Time frame: Neutrophil engraftment < 26 days
Rate of early neutrophil engraftment using Reduced Intensity Conditioning
To determine the rate of neutrophil engraftment after a single ProHema-CB unit is used as part of a double CB transplant following reduced intensity conditioning for subjects with hematologic malignancies.
Time frame: Neutrophil engraftment < 21 days
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Massachusetts General Hospital
Boston, Massachusetts, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute- Hematopoietic Stem Cell Transplant Program
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
Mount Sinai Hospital
New York, New York, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
...and 1 more locations