Donor Matching Strategies for Blood Cancer Transplants

(BMT CTN 1702 Trial)

Recruiting at 51 trial locations

Overseen By Jenny Vogel

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Center for International Blood and Marrow Transplant Research

Disqualifiers: Prior allogeneic HCT, previous donor search

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

1753 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Stephanie J Lee, MD, MPH

Principal Investigator

Fred Hutchinson Cancer Center

Stefan Ciurea, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for patients with conditions like various leukemias, lymphomas, sickle cell disease, and aplastic anemia who need a stem cell transplant but don't have a closely matched family donor. They should be fit for transplantation based on their medical history and tests. Patients already having had an allogeneic transplant can't join.

Inclusion Criteria

I have a family member who could be a donor but is deemed unsuitable by the medical center.

I am deemed fit for a transplant from another person based on my health records and tests.

Patients may co-enroll with other interventional or observational studies

Exclusion Criteria

Previous formal unrelated donor search

I have not had a transplant from another person.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Donor Search and Assignment

Participants are assigned to donor search strategies based on their likelihood of finding a matched unrelated donor

Varies

Transplantation

Participants undergo transplantation using either matched unrelated donors or alternative donors

Immediate post-assignment

Follow-up

Participants are monitored for survival, graft failure, GVHD, and other outcomes

2 years

Treatment Details

Interventions

• Donor Search Prognosis Score

Trial Overview The study aims to see if searching for a fully matched unrelated donor before considering alternative donors leads to better survival within two years after joining the study compared to going straight to an alternative donor transplant.

Participant Groups

Group I: Donor Search Prognosis: MUD Very Unlikely Experimental Treatment 1 Intervention

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.

Group II: Donor Search Prognosis: MUD Very Likely Experimental Treatment 1 Intervention

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.

Group III: Donor Search Prognosis: MUD Less Likely Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Center for International Blood and Marrow Transplant Research

Lead Sponsor

Trials

40

Recruited

200,190,000+

National Marrow Donor Program

Collaborator

Trials

63

Recruited

202,000+

Medical College of Wisconsin

Collaborator

Trials

645

Recruited

1,180,000+

Blood and Marrow Transplant Clinical Trials Network

Collaborator

Trials

51

Recruited

14,600+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+