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.
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
- Conditions the study is for
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndromes
- 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
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.
- Conditions
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndromes, Non-hodgkin Lymphoma, Hodgkin Lymphoma, Acquired Aplastic Anemia
- 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 group | Role | What they receive |
|---|---|---|
| Donor Search Prognosis: MUD Very Likely | Other | 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. Receives: Other: Donor Search Prognosis Score |
| Donor Search Prognosis: MUD Very Unlikely | Other | 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. Receives: Other: Donor Search Prognosis Score |
| Donor Search Prognosis: MUD Less Likely | Other | 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. Receives: Other: Donor Search Prognosis Score |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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.
- First posted5 Apr 2019
- Study start14 Jun 2019
- Primary completion6 Jan 2025
- Study completion6 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Center for International Blood and Marrow Transplant Research
- Sponsor type
- Research network
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Cancer Institute (NCI), Blood and Marrow Transplant Clinical Trials Network, National Marrow Donor Program, Medical College of Wisconsin
- Responsible party
- Sponsor
- Investigators
- Stephanie J Lee, MD, MPH, Study chair, Fred Hutchinson Cancer CenterStefan Ciurea, MD, Study chair, M.D. Anderson Cancer Center
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Transplant-Related Long-term Outcomes of Alternative Donor Allogeneic Transplantation (BMT CTN 1702)
- ClinicalTrials.gov ID
- NCT03904134
- Acronym / sponsor ID
- BMT CTN 1702 / BMT CTN 1702
- Conditions
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndromes, Non-hodgkin Lymphoma, Hodgkin Lymphoma, Acquired Aplastic Anemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,753 participants (actual)
- Lead sponsor
- Center for International Blood and Marrow Transplant ResearchResearch network
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Cancer Institute (NCI), Blood and Marrow Transplant Clinical Trials Network, National Marrow Donor Program, Medical College of Wisconsin
- Study start
- 14 Jun 2019 (actual)
- Primary completion
- 6 Jan 2025 (actual)
- Study completion
- 6 Jan 2025 (actual)
- First posted
- 5 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Donor Search Prognosis: MUD Very Likely | Other | Other: Donor Search Prognosis ScorePatients 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. |
| Donor Search Prognosis: MUD Very Unlikely | Other | Other: Donor Search Prognosis ScorePatients 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. |
| Donor Search Prognosis: MUD Less Likely | Other | Other: Donor Search Prognosis ScorePatients 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 may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (2 listed)
- Prior allogeneic HCT (prior autologous transplant is allowed)
- Previous formal unrelated donor search
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Donor Search Prognosis ScorePatients 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. | Other | Donor Search Prognosis: MUD Less Likely, Donor Search Prognosis: MUD Very Likely, Donor Search Prognosis: MUD Very Unlikely |
Primary outcome
Overall Survival for MUD Very Likely and MUD Very Unlikely Arms
Time frame: 2 years
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.
2 secondary outcomes
Cumulative Incidence of Transplant by Donor Search Prognosis Score
Time frame: 2 years
Barriers to Transplant
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Derived from this study: PubMed 42263667Bashey 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie J Lee, MD, MPH study chair
Fred Hutchinson Cancer Center
Stefan Ciurea, MD study chair
M.D. Anderson Cancer Center
52 sites in 1 country: see every site and its status.
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; AzTrials last refreshed its copy on 8 Nov 2026.