Donor Matching Strategies for Blood Cancer Transplants

(BMT CTN 1702 Trial)

No longer recruiting at 54 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best strategy for finding a donor for individuals needing a bone marrow transplant due to blood cancers or disorders such as AML, ALL, MDS, NHL, HL, AA, or SCD. Researchers compare two methods: one begins with searching for a perfect match from an unrelated donor, while the other uses alternative donor sources immediately if a perfect match seems unlikely. The goal is to determine which method leads to better survival rates within two years. The Donor Search Prognosis Score helps evaluate these strategies. Suitable participants have blood cancer or serious blood disorders, plan to undergo a transplant soon, and lack a suitable family donor. As an unphased trial, this study provides patients a unique opportunity to contribute to research that could enhance donor matching strategies for future transplant recipients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this donor matching strategy is safe for blood cancer transplants?

Research has shown that the Donor Search Prognosis Score predicts the likelihood of finding a matching donor for blood cancer transplants. Studies have found that using this score improves transplant outcomes for patients, regardless of their likelihood of finding a perfect match.

The score does not involve taking any medicine or undergoing any procedure, so it poses no safety concerns like side effects. It uses data to enhance decision-making during the transplant process.

For those considering joining a trial that uses the Donor Search Prognosis Score, there is no direct risk from the score itself. Instead, it aids doctors in finding the best donor match, potentially increasing the transplant's success. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative donor matching strategies for blood cancer transplants. Unlike traditional methods that primarily focus on finding a perfect 8/8 HLA-matched unrelated donor (MUD), this trial introduces the Donor Search Prognosis Score to predict the likelihood of finding a suitable donor. This approach could streamline the donor search process by identifying whether patients should pursue alternative options like haploidentical, cord blood, or mismatched donor transplants. By refining donor matching criteria, this trial aims to improve outcomes and expand transplant options for patients with blood cancers.

What evidence suggests that this trial's donor matching strategies could be effective for blood cancer transplants?

This trial evaluates different donor matching strategies using the Donor Search Prognosis Score to enhance the success of blood cancer transplants. Participants will be categorized based on their likelihood of finding a matched unrelated donor (MUD). For those unlikely to find a MUD, the trial will prioritize alternative donors, such as a partially matched family member or cord blood donor. Research has shown that these strategies can achieve similar transplant success rates to those with a perfect match. This approach helps avoid delays and improves survival chances for patients needing a transplant. The score uses data on HLA haplotype, a group of genes related to immune system compatibility, to facilitate these matches. ^{1 2 6 7 8}

Who Is on the Research Team?

Stephanie J Lee, MD, MPH

Principal Investigator

Fred Hutchinson Cancer Center

Stefan Ciurea, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. nmdp.org nmdp.org/what-we-do/news/press-releases/new-results-show-donor-search-prognosis-score-equalizes-transplant-outcomes

New results show donor search prognosis score equalizes ... Data from oral presentation show similar transplant success regardless of likelihood of finding a matched unrelated donor.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11451755/

Access to Allogeneic Cell Transplantation Based on Donor ... The National Marrow Donor Program® (NMDP) developed a Search Prognosis calculator, which uses HLA haplotype frequency data along with a ...

3. ascopubs.org ascopubs.org/doi/abs/10.1200/JCO-25-00206

Primary Results From Blood and Marrow Transplant ... Using a donor search prognosis strategy to prioritize an alternative donor for patients Very Unlikely to find a MUD resulted in survival and ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2666636725012904

Review Allogeneic Hematopoietic Cell Donor Selection Ongoing efforts are focused on refining and optimizing search prognosis scoring systems to further enhance donor search efficiency [92].

5. bloodcancerstoday.com bloodcancerstoday.com/post/new-donor-strategy-boosts-transplant-success-for-hard-to-match-patients

New Donor Strategy Boosts Transplant Success for Hard-to ... However, a new donor search prognosis scoring system can help prevent transplant delays for patients unlikely to find a matched unrelated donor.

6. cancernetwork.com cancernetwork.com/view/prognosis-strategy-exhibits-similar-transplant-outcomes-in-select-patients

Prognosis Strategy Exhibits Similar Transplant Outcomes ... A study by the Blood and Marrow Transplant Clinical Trials Network found that a donor search prognosis strategy may move those with cancer ...

7. ashpublications.org ashpublications.org/blood/article/144/Supplement%201/695/531543/Likelihood-of-finding-an-8-8-HLA-matched-unrelated

Likelihood of finding an 8/8 HLA-matched unrelated donor ... Likelihood of finding an 8/8 HLA-matched unrelated donor (Donor Search Prognosis) is not associated with survival: Primary results from BMT CTN 1702.

8. astctjournal.org astctjournal.org/article/S2666-6367(23)01109-0/fulltext

An Optimized Search Prognosis Tool to Predict 8/8 HLA ... An optimized tool can accurately classify 8/8 HLA-matched unrelated donor (URD) search prognosis and procurement.