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

Status
Closed
Cancer Type
Cancer-Related Syndrome
Hodgkin Lymphoma
Leukemia
Lymphoma
Myelodysplastic Syndromes (MDS)
Non-Hodgkin Lymphoma
Trial Phase
Eligibility
0 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT03904134
Protocol IDs
BMT CTN 1702 (primary)
NCI-2019-03477
N00014-18-1-2888
5U24HL138660-02
Study Sponsor
Center for International Blood and Marrow Transplant Research

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.

Objectives

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.

Eligibility

  1. 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. 1. Patients of all ages with AML, ALL, MDS, NHL, HL, AA, or SCD are eligible. 2. Any planned conditioning regimen and GVHD prophylaxis approach is eligible. 3. 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. 4. Patient and physician must intend to proceed with allogeneic HCT within the next 6 months if a suitable donor is identified. 5. 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. 6. 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: 1. Prior allogeneic HCT (prior autologous transplant is allowed) 2. Previous formal unrelated donor search
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