Spots Global Cancer Trial Database for Double Cord Versus Haploidentical (BMT CTN 1101)
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Trial Identification
Brief Title: Double Cord Versus Haploidentical (BMT CTN 1101)
Official Title: A Multi-Center, Phase III, Randomized Trial of RIC and Transplantation of (dUCB) Versus HLA-Haplo Related Bone Marrow for Patients With Hematologic Malignancies.(BMT CTN #1101)
Study ID: NCT01597778
Study Description
Brief Summary: Hematopoietic cell transplants (HCT)are one treatment option for people with leukemia or lymphoma. Family members,unrelated donors or banked umbilical cordblood units with similar tissue type can be used for HCT. This study will compare the effectiveness of two new types of bone marrow transplants in people with leukemia or lymphoma: one that uses bone marrow donated from family members with only partially matched bone marrow; and, one that uses two partially matched cord blood units.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham, Birmingham, Alabama, United States
Arizona Cancer Center, Phoenix, Arizona, United States
City of Hope National Medical Center, Duarte, California, United States
University of California at Los Angeles, Los Angeles, California, United States
Stanford Hospital and Clinics, Stanford, California, United States
University of Florida College of Medicine (Shands), Gainesville, Florida, United States
Florida Hospital Cancer Institute, Orlando, Florida, United States
Emory University, Atlanta, Georgia, United States
BMT Program at Northside Hospital, Atlanta, Georgia, United States
University of Kansas Hospital, Kansas City, Kansas, United States
Johns Hopkins University, Baltimore, Maryland, United States
DFCI Massachustts General Hospital, Boston, Massachusetts, United States
DFCI Brigham & Women's Hospital, Boston, Massachusetts, United States
University of Michigan Medical Center, Ann Arbor, Michigan, United States
Karmanos Cancer Institute/BMT, Detroit, Michigan, United States
Univeristy of Minnesota, Minneapolis, Minnesota, United States
Mayo Clinic Rochester, Rochester, Minnesota, United States
Roswell Park Cancer Center, Buffalo, New York, United States
Mt. Sinai Medical Center, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
University of Rochester Medical Center, Rochester, New York, United States
Stony Brook University Medical Center, Stony Brook, New York, United States
University of North Carolina Hospital at Chapel Hill, Chapel Hill, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
Jewish Hospital BMT Program, Cincinnati, Ohio, United States
University Hospitals of Cleveland, Case Western, Cleveland, Ohio, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
Ohio State / Arthur G. James Cancer Hospital, Columbus, Ohio, United States
University of Oklahoma Medical Center, Oklahoma City, Oklahoma, United States
Penn State College of Medicine - The Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
Univesity of Texas, MD Anderson CRC, Houston, Texas, United States
Texas Transplant Institute, San Antonio, Texas, United States
Virginia Commonwealth University, Richmond, Virginia, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
West Virginia University, Morgantown, West Virginia, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Contact Details
Name: Mary Horowitz, MD, MS
Affiliation: Center for International Blood and Marrow Transplant Research (CIBMTR), Medical College of Wisconsin
Role: STUDY_DIRECTOR
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