Clinical Transplant-Related Long-term Outcomes of Alternative Donor Allogeneic Transplantation (BMT CTN 1702)
- Conditions
- Myelodysplastic SyndromesHodgkin LymphomaAcute Lymphoblastic LeukemiaSickle Cell DiseaseAcute Myeloid LeukemiaNon-hodgkin LymphomaAcquired Aplastic Anemia
- Registration Number
- NCT03904134
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1753
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.
- Prior allogeneic HCT (prior autologous transplant is allowed)
- Previous formal unrelated donor search
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Overall Survival for MUD Very Likely and MUD Very Unlikely Arms 2 years Compare overall survival between Very Likely to find a matched unrelated donor search prognosis patients and Very Unlikely to find a matched unrelated donor search prognosis patients who are evaluable.
- Secondary Outcome Measures
Name Time Method Cumulative Incidence of Transplant by Donor Search Prognosis Score 2 years To estimate and compare the cumulative incidence of receiving a transplant according to donor search prognosis, regardless of donor search prognosis
Barriers to Transplant 2 years To describe barriers to achieving transplantation with different donor search strategies, regardless of donor search prognosis
Trial Locations
- Locations (52)
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
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