Clinical Transplant-Related Long-term Outcomes of Alternative Donor Allogeneic Transplantation

  • STATUS
    Recruiting
  • End date
    Mar 23, 2025
  • participants needed
    1732
  • sponsor
    Center for International Blood and Marrow Transplant Research
Updated on 23 May 2021
graft versus host disease
cell transplantation
transplant conditioning
biological factors
allogeneic transplantation

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.

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.

Details
Condition Bone marrow disorder, childhood ALL, Hodgkin's Disease, Lymphoma, Preleukemia, Acute myeloid leukemia, Lymphoma, MYELODYSPLASTIC SYNDROME, SICKLE CELL ANEMIA, Non-Hodgkin's Lymphoma, Myelodysplastic Syndromes (MDS), Acute Myelogenous Leukemia (AML), Acquired Aplastic Anemia, Lymphocytic Leukemia, Acute, Sickle Cell Disease, acute lymphoblastic leukemia, leukemia, acute lymphoblastic, myelodysplastic syndromes, non-hodgkin's lymphoma (nhl), myelodysplastic syndrome (mds), hodgkin, hodgkin's lymphomas, hodgkin lymphomas, hodgkins lymphoma, hodgkin's lymphoma, acute lymphoid leukaemia, acute lymphocytic leukemia, acute lymphoblastic leukemia (all), acute myelogenous leukemia, anll, acute myeloblastic leukemia
Treatment Donor Search Prognosis Score
Clinical Study IdentifierNCT03904134
SponsorCenter for International Blood and Marrow Transplant Research
Last Modified on23 May 2021

Eligibility

Yes No Not Sure

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
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