A Multi-Center, Phase III, Randomized Trial of Reduced Intensity (RIC) Conditioning and Transplantation of Double Unrelated Umbilical Cord Blood (dUCB) Versus HLA-Haploidentical Related Bone Marrow (Haplo-BM) for Patients With Hematologic Malignancies (BMT CTN #1101)
Reduced intensity conditioning (RIC) blood or marrow transplantation (BMT) has allowed older
and less clinically fit patients to receive potentially curative treatment with allogeneic
HCT for high risk or advanced hematological malignancies. Patients lacking an HLA-matched
sibling may receive a graft from a suitably HLA-matched unrelated donor. However, up to a
third of patients will not have an HLA-matched sibling or a suitably matched adult unrelated
donor (i.e., no more than a mismatch at a single locus). Even when a suitably matched
unrelated donor is identified, data from the National Marrow Donor Program (NMDP) indicate
that a median of four months is required to complete searches that result in
transplantation; thus, some number of patients succumb to their disease while awaiting
identification and evaluation of a suitably matched adult unrelated donor.
Single or dual center studies have shown that partially HLA-mismatched related bone marrow
(haplo-BM) and unrelated double umbilical cord blood (dUCB) are valuable sources of donor
cells for RIC HCT, thus extending this treatment modality to patients who lack other donors.
In order to study the reproducibility, and thus, the wider applicability of these two
alternative donor strategies, The Blood and Marrow Transplantation Clinical Trials Network
(BMT CTN) conducted two parallel multicenter prospective Phase II clinical trials. These
two studies evaluated the safety and efficacy of related haplo-BM (BMT CTN 0603) and dUCB
(BMT CTN 0604) transplantation after RIC. Both of these alternative donor approaches
produced early results similar to that reported with unrelated donor, and even HLA-matched
sibling, HCT. These data demonstrate not only the efficacy of both of these approaches, but
also that both can be safely exported from the single center setting. Both haplo-BM and
dUCB grafts can be obtained rapidly for greater than 90% of patients lacking an HLA-matched
donor. This study will test the hypothesis that progression free survival at two years
after RIC haplo-BM transplantation is similar to the progression free survival after RIC
dUCB transplantation.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression free survival
The primary endpoint is PFS at 2-years from the date of randomization. PFS is defined as the time interval from date of randomization and time to relapse/progression, to death or to last follow-up.
two years from the date of randomization
No
Mary Horowitz, MD, MS
Study Director
Center for International Blood and Marrow Transplant Research (CIBMTR), Medical College of Wisconsin
United States: Federal Government
715
NCT01597778
June 2012
June 2019
Name | Location |
---|---|
Johns Hopkins University | Baltimore, Maryland 21205 |
Cleveland Clinic Foundation | Cleveland, Ohio 44195 |
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
University Hospitals of Cleveland | Cleveland, Ohio 44106 |
University of Rochester Medical Center | Rochester, New York 14642 |
City of Hope National Medical Center | Los Angeles, California 91010 |
Duke University Medical Center | Durham, North Carolina 27710 |
Emory University | Atlanta, Georgia 30322 |
Virginia Commonwealth University | Richmond, Virginia |
Stanford Hospital and Clinics | Stanford, California 94305 |
University of Kansas Hospital | Kansas City, Kansas 66160 |
West Virginia University | Morgantown, West Virginia 26506 |
Stony Brook University Medical Center | Stony Brook, New York 11794 |
BMT Program at Northside Hospital | Atlanta, Georgia 30342 |
University of North Carolina Hospital at Chapel Hill | Chapel Hill, North Carolina 27599 |
Dana Farber Cancer Institute, Brigham & Women's Hospital | Boston, Massachusetts 02115 |
Univeristy of Minnesota | Minneapolis, Minnesota 55455 |
University of Florida College of Medicine/Shands | Gainesville, Florida 32610-0277 |
Univesity of Texas, MD Anderson CRC | Houston, Texas 77030 |