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Acute Myeloid LeukemiaBMT CTN 1702NCT03904134

Clinical Transplant-Related Long-term Outcomes of Alternative Donor Allogeneic Transplantation (BMT CTN 1702)

A study testing Donor Search Prognosis Score in people with Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, run by Center for International Blood and Marrow Transplant Research at 52 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Any age
What is being tested?
Donor Search Prognosis Score
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,753 participants
Where
52 sitesUnited States
Study dates
14 Jun 2019to 6 Jan 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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: (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.
  • 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.

Who cannot join

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

Trial locations and contacts

52 sites in 1 country.

52 sites in 1 country

United States52 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Children's Healthcare of Atlanta

    Atlanta, Georgia, 30322

  • Emory University

    Atlanta, Georgia, 30322

  • Northside Hospital

    Atlanta, Georgia, 30342

  • University of Maryland

    Baltimore, Maryland, 21201

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Rosewell Park Cancer Institute

    Buffalo, New York, 14263

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • University of Virginia

    Charlottesville, Virginia, 22903

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205

  • The Ohio State University

    Columbus, Ohio, 43210

  • Children's Medical Center Dallas

    Dallas, Texas, 75235

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • City of Hope

    Duarte, California, 91010

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Cook Children's Medical Center

    Fort Worth, Texas, 76104

  • University of Florida

    Gainesville, Florida, 32610

  • Baylor College of Medicine

    Houston, Texas, 77030

  • M.D. Anderson Cancer Center

    Houston, Texas, 77030

  • Indiana University

    Indianapolis, Indiana, 46202

  • University of Mississippi

    Jackson, Mississippi, 39216

  • Children's Mercy Hospital

    Kansas City, Missouri, 64108

  • University of California, San Diego Medical Center

    La Jolla, California, 92093

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027

  • University of Wisconsin

    Madison, Wisconsin, 53792

  • Loyola University

    Maywood, Illinois, 60153

  • University of Miami

    Miami, Florida, 33136

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • University of Minnesota

    Minneapolis, Minnesota, 55414

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • University of Oklahoma

    Oklahoma City, Oklahoma, 73104

  • University of Nebraska Medical Center - Adults

    Omaha, Nebraska, 68105

  • University of Nebraska Medical Center - Pediatrics

    Omaha, Nebraska, 68105

  • Memorial Healthcare System

    Pembroke Pines, Florida, 33028

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

  • University of Utah

    Salt Lake City, Utah, 84113

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

  • St. Louis Children's Hospital

    St Louis, Missouri, 63110

  • Washington University in St. Louis

    St Louis, Missouri, 63110

  • Stanford Hospitals and Clinics

    Stanford, California, 94305

  • H. Lee Moffitt Cancer Center

    Tampa, Florida, 33612

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

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.

Read the 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.

Being tested
Donor Search Prognosis Score
Medical subject headings
Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Myelodysplastic Syndromes, Lymphoma, Non-Hodgkin, Hodgkin Disease, Anemia, Sickle Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Donor Search Prognosis ScoreOther

    Patients will be placed on a study arm after receiving a Donor Search Prognosis Score, which is based on HLA allele frequencies and race/ethnicity. This score predicts the likelihood of successfully identifying a 10/10 matched unrelated donor.Worse search prognosis is associated with racial and ethnic minority status but not with other patient and disease biology characteristics that might influence the success of hematopoietic cell transplantation (HCT). Thus, the use of donor search prognosis in this trial as a tool for biologic assignment to matched unrelated donors vs. mismatched donors provides a mechanism to minimize bias from disease characteristics.

Study groups in NCT03904134
Study groupRoleWhat they receive
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.
Receives: Other: Donor Search Prognosis Score
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.
Receives: Other: Donor Search Prognosis Score
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.
Receives: Other: Donor Search Prognosis Score

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival for MUD Very Likely and MUD Very Unlikely Arms

    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.

    Measured: 2 years

Secondary outcomes (2)

  1. Cumulative Incidence of Transplant by Donor Search Prognosis Score

    To estimate and compare the cumulative incidence of receiving a transplant according to donor search prognosis, regardless of donor search prognosis

    Measured: 2 years

  2. Barriers to Transplant

    To describe barriers to achieving transplantation with different donor search strategies, regardless of donor search prognosis

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2019
  2. Study start14 Jun 2019
  3. Primary completion6 Jan 2025
  4. Study completion6 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
1,753 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03904134
Sponsor's protocol ID
BMT CTN 1702
Other IDs
5U24HL138660-02, N00014-18-1-2888
Acronym
BMT CTN 1702
Status last verified
Dec 2025
First submitted
1 Apr 2019
Last updated
5 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bashey A, Logan BR, Hill LC, Symons HJ, Farhadfar N, Grunwald MR, Pidala JA, Dehn JG, Brunstein C, Arai S, Leifer E, He N, Shaw BE, Juckett MB, Devine SM, Uberti J, Westervelt P, Srour SA, Pusic I, Vasu S, Hayes-Lattin B, Ciurea SO, Horowitz MM, Lee SJ, Hogan WJ. Donor-Specific Transplant Outcomes from BMTCTN 1702: A Multi-Center Prospective Biological-Assignment Trial. Blood Adv. 2026 Jun 5:bloodadvances.2026020355. doi: 10.1182/bloodadvances.2026020355. Online ahead of print.

    PubMed 42263667

Questions about this trial

What is this clinical trial studying?

A study testing Donor Search Prognosis Score in people with Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, run by Center for International Blood and Marrow Transplant Research at 52 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival for MUD Very Likely and MUD Very Unlikely Arms (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03904134, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.

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