Non Hodgkin Lymphoma Clinical Trial

Clinical Transplant-Related Long-term Outcomes of Alternative Donor Allogeneic Transplantation (BMT CTN 1702)

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Patients fulfilling the inclusion criteria will be eligible for enrollment in this study. Of those who consent, only patients who lack a suitable HLA-identical or 1 allele or antigen mismatched related donors are evaluable. Patients with an HLA-identical sibling or 1 allele or antigen mismatched family member donor are evaluable as long as the center deems the family member donor as unsuitable for other reasons. Patients may co-enroll with other interventional or observational studies.

Patients of all ages with AML, ALL, MDS, NHL, HL, AA, or SCD are eligible.
Any planned conditioning regimen and GVHD prophylaxis approach is eligible.
Patients must be considered suitable allogeneic transplant candidates at the time of enrollment based on medical history, physical examination, and available laboratory tests. Specific testing for organ function is not required for eligibility but, if available, these tests should be used by the treating physician to judge transplant suitability.
Patient and physician must intend to proceed with allogeneic HCT within the next 6 months if a suitable donor is identified.
Center plans to follow the algorithm for alternative donor identification: (a) for subjects who are Very Likely to find a MUD, attempt to identify a matched unrelated donor; (b) for a subjects who are Very Unlikely to find a MUD, proceed expeditiously to a haploidentical, cord blood or mismatched unrelated donor.
Signed informed consent, and assent if applicable. Consent may be signed prior to completion of family typing but patients will only be considered evaluable upon confirmation that there is no suitable HLA-identical or 1 allele or antigen mismatched related donor available.

Exclusion Criteria:

Prior allogeneic HCT (prior autologous transplant is allowed)
Previous formal unrelated donor search

Study is for people with:

Non Hodgkin Lymphoma

Estimated Enrollment:

1753

Study ID:

NCT03904134

Recruitment Status:

Active, not recruiting

Sponsor:

Center for International Blood and Marrow Transplant Research

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There are 47 Locations for this study

See Locations Near You

City of Hope
Duarte California, 91010, United States
University of California, San Diego Medical Center
La Jolla California, 92093, United States
Children's Hospital Los Angeles
Los Angeles California, 90027, United States
Stanford Hospitals and Clinics
Stanford California, 94305, United States
Children's National Medical Center
Washington District of Columbia, 20010, United States
University of Florida
Gainesville Florida, 32610, United States
University of Miami
Miami Florida, 33136, United States
Memorial Healthcare System
Pembroke Pines Florida, 33028, United States
H. Lee Moffitt Cancer Center
Tampa Florida, 33612, United States
Children's Healthcare of Atlanta
Atlanta Georgia, 30322, United States
Emory University
Atlanta Georgia, 30322, United States
Northside Hospital
Atlanta Georgia, 30342, United States
Loyola University
Maywood Illinois, 60153, United States
Indiana University
Indianapolis Indiana, 46202, United States
University of Maryland
Baltimore Maryland, 21201, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
University of Michigan
Ann Arbor Michigan, 48109, United States
Karmanos Cancer Institute
Detroit Michigan, 48201, United States
University of Minnesota
Minneapolis Minnesota, 55414, United States
Mayo Clinic Rochester
Rochester Minnesota, 55905, United States
University of Mississippi
Jackson Mississippi, 39216, United States
Children's Mercy Hospital
Kansas City Missouri, 64108, United States
St. Louis Children's Hospital
Saint Louis Missouri, 63110, United States
Washington University in St. Louis
Saint Louis Missouri, 63110, United States
University of Nebraska Medical Center - Adults
Omaha Nebraska, 68105, United States
University of Nebraska Medical Center - Pediatrics
Omaha Nebraska, 68105, United States
Rosewell Park Cancer Institute
Buffalo New York, 14263, United States
Mount Sinai Medical Center
New York New York, 10029, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
University of North Carolina
Chapel Hill North Carolina, 27599, United States
Levine Cancer Institute
Charlotte North Carolina, 28204, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
Wake Forest Baptist Health
Winston-Salem North Carolina, 27157, United States
University Hospitals Cleveland Medical Center
Cleveland Ohio, 44106, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
Nationwide Children's Hospital
Columbus Ohio, 43205, United States
The Ohio State University
Columbus Ohio, 43210, United States
University of Oklahoma
Oklahoma City Oklahoma, 73104, United States
Oregon Health and Science University
Portland Oregon, 97239, United States
Children's Hospital of Philadelphia
Philadelphia Pennsylvania, 19104, United States
University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Medical University of South Carolina
Charleston South Carolina, 29425, United States
Children's Medical Center Dallas
Dallas Texas, 75235, United States
Cook Children's Medical Center
Fort Worth Texas, 76104, United States
Baylor College of Medicine
Houston Texas, 77030, United States
M.D. Anderson Cancer Center
Houston Texas, 77030, United States
University of Utah
Salt Lake City Utah, 84113, United States
University of Virginia
Charlottesville Virginia, 22903, United States
Virginia Commonwealth University
Richmond Virginia, 23298, United States
Fred Hutchinson Cancer Research Center
Seattle Washington, 98109, United States
University of Wisconsin
Madison Wisconsin, 53792, United States
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Estimated Enrollment:

1753

Study ID:

NCT03904134

Recruitment Status:

Active, not recruiting

Sponsor:


Center for International Blood and Marrow Transplant Research

How clear is this clinincal trial information?

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