A Study to Evaluate Clinical Transplant-Related Long-term Outcomes of Alternative Donor Allogeneic Transplantation
Tab Title Description
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Rochester, Minnesota: 19-003272
NCT ID: NCT03904134
Sponsor Protocol Number: BMT CTN 1702
About this study
The primary purpose of this study is to estimate and compare overall survival between the two arms: patients who are Very Likely to find a Matched Unrelated Donor (MUD) versus those who are Very Unlikely to find a MUD.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.
- 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:
- for subjects who are Very Likely to find a MUD, attempt to identify a matched unrelated donor;
- 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.
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.
|Mayo Clinic Location
Mayo Clinic principal investigator
William Hogan, M.B., B.Ch.
Open for enrollment
Cancer Center Clinical Trials Referral Office
Publications are currently not available
Study Results Summary
Not yet available
Supplemental Study Information
Not yet available