Clinical Trials /

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

NCT03904134

Description:

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.

Related Conditions:
  • Acute Lymphoblastic Leukemia
  • Acute Myeloid Leukemia
  • Aplastic Anemia
  • Hodgkin Lymphoma
  • Myelodysplastic Syndromes
  • Non-Hodgkin Lymphoma
  • Sickle Cell Disease
Recruiting Status:

Recruiting

Phase:

N/A

URL:

https://clinicaltrials.gov/show/NCT03904134

Trial Eligibility

Document

Title

  • Brief Title: Clinical Transplant-Related Long-term Outcomes of Alternative Donor Allogeneic Transplantation
  • Official Title: Clinical Transplant-Related Long-term Outcomes of Alternative Donor Allogeneic Transplantation (BMT CTN 1702)

Clinical Trial IDs

  • ORG STUDY ID: BMT CTN 1702
  • SECONDARY ID: 5U24HL138660-02
  • SECONDARY ID: N00014-18-1-2888
  • NCT ID: NCT03904134

Conditions

  • Acute Myeloid Leukemia
  • Acute Lymphoblastic Leukemia
  • Myelodysplastic Syndromes
  • Non-hodgkin Lymphoma
  • Hodgkin Lymphoma
  • Acquired Aplastic Anemia
  • Sickle Cell Disease

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Donor Search Prognosis: MUD Very LikelyOtherPatients 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.
    Donor Search Prognosis: MUD Very UnlikelyOtherPatients 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.
      Donor Search Prognosis: MUD Less LikelyOtherPatients 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 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.

          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
        Maximum Eligible Age:N/A
        Minimum Eligible Age:N/A
        Eligible Gender:All
        Healthy Volunteers:No

        Primary Outcome Measures

        Measure:Overall Survival for MUD Very Likely and MUD Very Unlikely Arms
        Time Frame:2 years
        Safety Issue:
        Description: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

        Measure:Cumulative Incidence of Transplant by Donor Search Prognosis Score
        Time Frame:2 years
        Safety Issue:
        Description:To estimate and compare the cumulative incidence of receiving a transplant according to donor search prognosis, regardless of donor search prognosis
        Measure:Barriers to Transplant
        Time Frame:2 years
        Safety Issue:
        Description:To describe barriers to achieving transplantation with different donor search strategies, regardless of donor search prognosis

        Details

        Phase:N/A
        Primary Purpose:Interventional
        Overall Status:Recruiting
        Lead Sponsor:Center for International Blood and Marrow Transplant Research

        Last Updated

        May 14, 2021