Spots Global Cancer Trial Database for Clinical Transplant-Related Long-term Outcomes of Alternative Donor Allogeneic Transplantation (BMT CTN 1702)
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Trial Identification
Brief Title: Clinical Transplant-Related Long-term Outcomes of Alternative Donor Allogeneic Transplantation (BMT CTN 1702)
Official Title: Clinical Transplant-Related Long-term Outcomes of Alternative Donor Allogeneic Transplantation (BMT CTN 1702)
Study ID: NCT03904134
Interventions
Study Description
Brief Summary: The purpose of this study is to determine if a search strategy of searching for an HLA-matched unrelated donor for allogeneic transplantation if possible then an alternative donor if an HLA-matched unrelated donor is not available versus proceeding directly to an alternative donor transplant will result in better survival for allogeneic transplant recipients within 2 years after study enrollment.
Detailed Description: This is a multicenter, interventional and observational study to understand factors affecting the likelihood of transplantation in patients without a human leukocyte antigen (HLA) matched family donor and to compare outcomes associated with pursuing an HLA-identical unrelated versus other alternative donor graft sources. Alternative donors are defined as any donor other than an HLA-matched or 1 antigen-mismatched related donor. Patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), myelodysplastic syndromes (MDS), Non-Hodgkin lymphoma (NHL), Hodgkin lymphoma (HL), acquired aplastic anemia (AA) or sickle cell disease (SCD) are eligible. The primary comparison for the interventional study will be between two arms based on biologic assignment, analyzed on an intention-to-treat basis: Arm 1: Patients who are Very Likely to find a matched unrelated donor (MUD), defined as having a \>90% chance of finding an 8/8 HLA-matched unrelated donor, for whom a fully matched unrelated donor will be pursued; and Arm 2: Patients who are Very Unlikely to find a MUD, defined as having a \<10% chance of finding an 8/8 HLA-matched unrelated donor, for whom a haploidentical, cord blood, or mismatched unrelated donor transplant will be pursued. Patients with a Less Likely chance of finding a MUD, i.e., those not falling into the other two groups (a 26% chance), will be enrolled onto the observational component of the study and analyzed for all relevant endpoints but will not be included in the primary comparison.
Keywords
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope, Duarte, California, United States
University of California, San Diego Medical Center, La Jolla, California, United States
Children's Hospital Los Angeles, Los Angeles, California, United States
Stanford Hospitals and Clinics, Stanford, California, United States
Children's National Medical Center, Washington, District of Columbia, United States
University of Florida, Gainesville, Florida, United States
University of Miami, Miami, Florida, United States
Memorial Healthcare System, Pembroke Pines, Florida, United States
H. Lee Moffitt Cancer Center, Tampa, Florida, United States
Children's Healthcare of Atlanta, Atlanta, Georgia, United States
Emory University, Atlanta, Georgia, United States
Northside Hospital, Atlanta, Georgia, United States
Loyola University, Maywood, Illinois, United States
Indiana University, Indianapolis, Indiana, United States
University of Maryland, Baltimore, Maryland, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
University of Michigan, Ann Arbor, Michigan, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
University of Minnesota, Minneapolis, Minnesota, United States
Mayo Clinic Rochester, Rochester, Minnesota, United States
University of Mississippi, Jackson, Mississippi, United States
Children's Mercy Hospital, Kansas City, Missouri, United States
St. Louis Children's Hospital, Saint Louis, Missouri, United States
Washington University in St. Louis, Saint Louis, Missouri, United States
University of Nebraska Medical Center - Adults, Omaha, Nebraska, United States
University of Nebraska Medical Center - Pediatrics, Omaha, Nebraska, United States
Rosewell Park Cancer Institute, Buffalo, New York, United States
Mount Sinai Medical Center, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
University of North Carolina, Chapel Hill, North Carolina, United States
Levine Cancer Institute, Charlotte, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
Wake Forest Baptist Health, Winston-Salem, North Carolina, United States
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
Cleveland Clinic, Cleveland, Ohio, United States
Nationwide Children's Hospital, Columbus, Ohio, United States
The Ohio State University, Columbus, Ohio, United States
University of Oklahoma, Oklahoma City, Oklahoma, United States
Oregon Health and Science University, Portland, Oregon, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Children's Medical Center Dallas, Dallas, Texas, United States
Cook Children's Medical Center, Fort Worth, Texas, United States
Baylor College of Medicine, Houston, Texas, United States
M.D. Anderson Cancer Center, Houston, Texas, United States
University of Utah, Salt Lake City, Utah, United States
University of Virginia, Charlottesville, Virginia, United States
Virginia Commonwealth University, Richmond, Virginia, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
University of Wisconsin, Madison, Wisconsin, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Contact Details
Name: Stephanie J Lee, MD, MPH
Affiliation: Fred Hutchinson Cancer Center
Role: STUDY_CHAIR
Name: Stefan Ciurea, MD
Affiliation: M.D. Anderson Cancer Center
Role: STUDY_CHAIR
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