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Clinical Trial 20126

Cancer Type: Malignant Hematology
Study Type: Other
NCT#: NCT03904134

Phase: N/A
Principal Investigator: Pidala, Joseph

Call 813-745-6100
or 1-800-679-0775 Learn More
Overview

Study Title

Clinical Transplant-Related Long-term Outcomes of Alternative Donor Allogeneic Transplantation (CTRL-ALT-D)

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.

Objective

The primary objective is to estimate and compare overall survival between the two arms: patients who are Very Likely to find a MUD versus those who are Very Unlikely to find a MUD. Secondary objectives include all patients, regardless of donor search prognosis: 1. To estimate and compare the cumulative incidence of receiving a transplant according to donor search prognosis 2. To describe barriers to achieving transplantation with different alternative donor search strategies

Treatments

Therapies

Medications

Inclusion Criteria

Inclusion Criteria:

  • Participants fulfilling the inclusion criteria will be eligible for enrollment in this study. Of those who consent, only participants who lack a suitable HLA-identical or 1 allele or antigen mismatched related donors are evaluable. Participants 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. Participants may co-enroll with other interventional or observational studies.
  • Participants of all ages with AML, ALL, MDS, NHL, HL, AA, or SCD are eligible.
  • Any planned conditioning regimen and GVHD prophylaxis approach is eligible.
  • Participants 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.
  • Participant and physician must intend to proceed with allogeneic HCT within the next 6 months if a suitable donor is identified.
  • Signed informed consent, and assent if applicable. Consent may be signed prior to completion of family typing but participants 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

    Exclusion Criteria:

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

    • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.

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