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| ID | Type | Description | Link |
|---|---|---|---|
| 5U24HL138660-02 | U.S. NIH Grant/Contract | View source | |
| N00014-18-1-2888 | Other Grant/Funding Number | Office of Naval Research |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| National Cancer Institute (NCI) | NIH |
| Blood and Marrow Transplant Clinical Trials Network | NETWORK |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Donor Search Prognosis Score | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 years |
| Barriers to Transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival in patients transplanted for malignant diseases | To compare overall survival in patients transplanted for malignant diseases, according to the donor search prognosis and the alternative donor used. | 2 years |
| Relapse in patients transplanted for malignant diseases |
Inclusion Criteria:
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephanie J Lee, MD, MPH | Fred Hutchinson Cancer Center | Study Chair |
| Stefan Ciurea, MD | M.D. Anderson Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | United States | ||
| University of California, San Diego Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42263667 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 10, 2018 |
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| National Marrow Donor Program |
| OTHER |
| Medical College of Wisconsin | OTHER |
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.
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|
To describe barriers to achieving transplantation with different donor search strategies, regardless of donor search prognosis
| 2 years |
To compare relapse in patients transplanted for malignant diseases, according to the donor search prognosis and the alternative donor used. |
| 2 years |
| Disease-free survival in patients transplanted for malignant diseases | To compare disease-free survival, treatment-related mortality, and acute and chronic GVHD in patients transplanted for malignant diseases, according to the donor search prognosis and the alternative donor used. | 2 years |
| Treatment-related mortality in patients transplanted for malignant diseases | To compare treatment-related mortality in patients transplanted for malignant diseases, according to the donor search prognosis and the alternative donor used. | 2 years |
| Acute and chronic GVHD in patients transplanted for malignant diseases | To compare acute and chronic GVHD in patients transplanted for malignant diseases, according to the donor search prognosis and the alternative donor used. | 2 years |
| Survival in patients with acquired aplastic anemia and sickle cell disease after transplantation | To describe survival in patients with acquired aplastic anemia and sickle cell disease after transplantation, according to the donor search prognosis and the alternative donor used. | 2 years |
| Acute and chronic GVHD in patients with acquired aplastic anemia and sickle cell disease after transplantation | To describe acute and chronic GVHD in patients with acquired aplastic anemia and sickle cell disease after transplantation, according to the donor search prognosis and the alternative donor used. | 2 years |
| AML or ALL in first complete remission or early stage MDS Substudy - QoL | In patients with AML or ALL in first complete remission or early stage MDS treated with a limited subset of conditioning and GVHD prophylaxis regimens and transplanted with either matched unrelated donors or haploidentical related donors (QOL Substudy), to compare QOL, according to the donor search prognosis and alternative donor used. | 2 years |
| AML or ALL in first complete remission or early stage MDS Substudy - primary graft failure | In patients with AML or ALL in first complete remission or early stage MDS treated with a limited subset of conditioning and GVHD prophylaxis regimens and transplanted with either matched unrelated donors or haploidentical related donors (QOL Substudy), to describe the incidence of primary graft failure, according to the donor search prognosis and alternative donor used. | 2 years |
| AML or ALL in first complete remission or early stage MDS Substudy - chronic GVHD | In patients with AML or ALL in first complete remission or early stage MDS treated with a limited subset of conditioning and GVHD prophylaxis regimens and transplanted with either matched unrelated donors or haploidentical related donors (QOL Substudy), to describe the incidence of chronic GVHD, according to the donor search prognosis and alternative donor used. | 2 years |
| AML or ALL in first complete remission or early stage MDS Substudy - time until off systemic immunosuppression | In patients with AML or ALL in first complete remission or early stage MDS treated with a limited subset of conditioning and GVHD prophylaxis regimens and transplanted with either matched unrelated donors or haploidentical related donors (QOL Substudy), to describe time until off systemic immunosuppression, according to the donor search prognosis and alternative donor used. | 2 years |
| AML or ALL in first complete remission or early stage MDS Substudy - GRFS | In patients with AML or ALL in first complete remission or early stage MDS treated with a limited subset of conditioning and GVHD prophylaxis regimens and transplanted with either matched unrelated donors or haploidentical related donors (QOL Substudy), to describe the incidence of acute grade III-IV and chronic GVHD requiring immunosuppression-free, relapse-free survival (GRFS), according to the donor search prognosis and alternative donor used. | 2 years |
| AML or ALL in first complete remission or early stage MDS Substudy - CRFS | In patients with AML or ALL in first complete remission or early stage MDS treated with a limited subset of conditioning and GVHD prophylaxis regimens and transplanted with either matched unrelated donors or haploidentical related donors (QOL Substudy), to describe the incidence of moderate-severe chronic GVHD relapse-free survival (CRFS), according to the donor search prognosis and alternative donor used. | 2 years |
| AML or ALL in first complete remission or early stage MDS Substudy - current CRFS | In patients with AML or ALL in first complete remission or early stage MDS treated with a limited subset of conditioning and GVHD prophylaxis regimens and transplanted with either matched unrelated donors or haploidentical related donors (QOL Substudy), to describe the incidence of current CRFS (still on systemic treatment for cGVHD), according to the donor search prognosis and alternative donor used. | 2 years |
| QOL Substudy - number of hospital days | In patients with AML or ALL in first complete remission or early stage MDS treated with a limited subset of conditioning and GVHD prophylaxis regimens and transplanted with either matched unrelated donors or haploidentical related donors (QOL Substudy), to describe the number of hospital days in the first 100 post-transplant days, according to the donor search prognosis and alternative donor used. | 2 years |
| QOL Substudy - infections | In patients with AML or ALL in first complete remission or early stage MDS treated with a limited subset of conditioning and GVHD prophylaxis regimens and transplanted with either matched unrelated donors or haploidentical related donors (QOL Substudy), to describe the incidence of infections, according to the donor search prognosis and alternative donor used. | 2 years |
| QOL Substudy - immune reconstitution | In patients with AML or ALL in first complete remission or early stage MDS treated with a limited subset of conditioning and GVHD prophylaxis regimens and transplanted with either matched unrelated donors or haploidentical related donors (QOL Substudy), to describe the incidence of immune reconstitution, according to the donor search prognosis and alternative donor used. | 2 years |
| QOL Substudy - late effects after transplantation | In patients with AML or ALL in first complete remission or early stage MDS treated with a limited subset of conditioning and GVHD prophylaxis regimens and transplanted with either matched unrelated donors or haploidentical related donors (QOL Substudy), to describe the late effects after transplantation, according to the donor search prognosis and alternative donor used. | 2 years |
| La Jolla |
| California |
| 92093 |
| United States |
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | United States |
| Stanford Hospitals and Clinics | Stanford | California | 94305 | United States |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | United States |
| University of Florida | Gainesville | Florida | 32610 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| Memorial Healthcare System | Pembroke Pines | Florida | 33028 | United States |
| H. Lee Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| Children's Healthcare of Atlanta | Atlanta | Georgia | 30322 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Northside Hospital | Atlanta | Georgia | 30342 | United States |
| Loyola University | Maywood | Illinois | 60153 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| University of Maryland | Baltimore | Maryland | 21201 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55414 | United States |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
| University of Mississippi | Jackson | Mississippi | 39216 | United States |
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | United States |
| St. Louis Children's Hospital | St Louis | Missouri | 63110 | United States |
| Washington University in St. Louis | St Louis | Missouri | 63110 | United States |
| University of Nebraska Medical Center - Adults | Omaha | Nebraska | 68105 | United States |
| University of Nebraska Medical Center - Pediatrics | Omaha | Nebraska | 68105 | United States |
| Rosewell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| Levine Cancer Institute | Charlotte | North Carolina | 28204 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| University of Oklahoma | Oklahoma City | Oklahoma | 73104 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Children's Medical Center Dallas | Dallas | Texas | 75235 | United States |
| Cook Children's Medical Center | Fort Worth | Texas | 76104 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| M.D. Anderson Cancer Center | Houston | Texas | 77030 | United States |
| University of Utah | Salt Lake City | Utah | 84113 | United States |
| University of Virginia | Charlottesville | Virginia | 22903 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | United States |
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Apr 1, 2019 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 19, 2019 | Jan 25, 2023 | ICF_001.pdf |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D009190 | Myelodysplastic Syndromes |
| D008228 | Lymphoma, Non-Hodgkin |
| D006689 | Hodgkin Disease |
| D000755 | Anemia, Sickle Cell |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D001855 | Bone Marrow Diseases |
| D008223 | Lymphoma |
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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