- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03904134
Clinical Transplant-Related Long-term Outcomes of Alternative Donor Allogeneic Transplantation (BMT CTN 1702) (BMT CTN 1702)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Duarte, California, United States, 91010
- City of Hope
-
La Jolla, California, United States, 92093
- University of California, San Diego Medical Center
-
Los Angeles, California, United States, 90027
- Children's Hospital Los Angeles
-
Stanford, California, United States, 94305
- Stanford Hospitals and Clinics
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20010
- Children's National Medical Center
-
-
Florida
-
Gainesville, Florida, United States, 32610
- University of Florida
-
Miami, Florida, United States, 33136
- University of Miami
-
Pembroke Pines, Florida, United States, 33028
- Memorial Healthcare System
-
Tampa, Florida, United States, 33612
- H. Lee Moffitt Cancer Center
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Children's Healthcare of Atlanta
-
Atlanta, Georgia, United States, 30322
- Emory University
-
Atlanta, Georgia, United States, 30342
- Northside Hospital
-
-
Illinois
-
Maywood, Illinois, United States, 60153
- Loyola University
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Indiana University
-
-
Maryland
-
Baltimore, Maryland, United States, 21201
- University of Maryland
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Dana Farber Cancer Institute
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- University of Michigan
-
Detroit, Michigan, United States, 48201
- Karmanos Cancer Institute
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55414
- University of Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic Rochester
-
-
Mississippi
-
Jackson, Mississippi, United States, 39216
- University of Mississippi
-
-
Missouri
-
Kansas City, Missouri, United States, 64108
- Children's Mercy Hospital
-
Saint Louis, Missouri, United States, 63110
- St. Louis Children's Hospital
-
Saint Louis, Missouri, United States, 63110
- Washington University in St. Louis
-
-
Nebraska
-
Omaha, Nebraska, United States, 68105
- University of Nebraska Medical Center - Adults
-
Omaha, Nebraska, United States, 68105
- University of Nebraska Medical Center - Pediatrics
-
-
New York
-
Buffalo, New York, United States, 14263
- Rosewell Park Cancer Institute
-
New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
-
New York, New York, United States, 10029
- Mount Sinai Medical Center
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599
- University of North Carolina
-
Charlotte, North Carolina, United States, 28204
- Levine Cancer Institute
-
Durham, North Carolina, United States, 27710
- Duke University Medical Center
-
Winston-Salem, North Carolina, United States, 27157
- Wake Forest Baptist Health
-
-
Ohio
-
Cleveland, Ohio, United States, 44195
- Cleveland Clinic
-
Cleveland, Ohio, United States, 44106
- University Hospitals Cleveland Medical Center
-
Columbus, Ohio, United States, 43205
- Nationwide Children's Hospital
-
Columbus, Ohio, United States, 43210
- The Ohio State University
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73104
- University of Oklahoma
-
-
Oregon
-
Portland, Oregon, United States, 97239
- Oregon Health and Science University
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Children's Hospital of Philadelphia
-
Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
-
-
Texas
-
Dallas, Texas, United States, 75235
- Children's Medical Center Dallas
-
Fort Worth, Texas, United States, 76104
- Cook Children's Medical Center
-
Houston, Texas, United States, 77030
- Baylor College of Medicine
-
Houston, Texas, United States, 77030
- M.D. Anderson Cancer Center
-
-
Utah
-
Salt Lake City, Utah, United States, 84113
- University of Utah
-
-
Virginia
-
Charlottesville, Virginia, United States, 22903
- University of Virginia
-
Richmond, Virginia, United States, 23298
- Virginia Commonwealth University
-
-
Washington
-
Seattle, Washington, United States, 98109
- Fred Hutchinson Cancer Research Center
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53792
- University of Wisconsin
-
Milwaukee, Wisconsin, United States, 53226
- Medical College of Wisconsin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
- 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.
Exclusion Criteria:
- Prior allogeneic HCT (prior autologous transplant is allowed)
- Previous formal unrelated donor search
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Donor Search Prognosis: MUD Very Likely
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.
|
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.
|
Other: Donor Search Prognosis: MUD Very Unlikely
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 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
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cumulative Incidence of Transplant by Donor Search Prognosis Score
Time Frame: 2 years
|
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
Time Frame: 2 years
|
To describe barriers to achieving transplantation with different donor search strategies, regardless of donor search prognosis
|
2 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival in patients transplanted for malignant diseases
Time Frame: 2 years
|
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
Time Frame: 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
Time Frame: 2 years
|
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
Time Frame: 2 years
|
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
Time Frame: 2 years
|
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
Time Frame: 2 years
|
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
Time Frame: 2 years
|
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
Time Frame: 2 years
|
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
Time Frame: 2 years
|
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
Time Frame: 2 years
|
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
Time Frame: 2 years
|
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
Time Frame: 2 years
|
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
Time Frame: 2 years
|
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
Time Frame: 2 years
|
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
Time Frame: 2 years
|
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
Time Frame: 2 years
|
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
Time Frame: 2 years
|
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
Time Frame: 2 years
|
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
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Stefan Ciurea, MD, M.D. Anderson Cancer Center
- Study Chair: Stephanie J Lee, MD, MPH, Fred Hutchinson Cancer Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Bone Marrow Diseases
- Hematologic Diseases
- Genetic Diseases, Inborn
- Anemia
- Leukemia, Lymphoid
- Anemia, Hemolytic, Congenital
- Anemia, Hemolytic
- Hemoglobinopathies
- Bone Marrow Failure Disorders
- Lymphoma
- Myelodysplastic Syndromes
- Leukemia
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Anemia, Sickle Cell
- Anemia, Aplastic
Other Study ID Numbers
- BMT CTN 1702
- 5U24HL138660-02 (U.S. NIH Grant/Contract)
- N00014-18-1-2888 (Other Grant/Funding Number: Office of Naval Research)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Myeloid Leukemia
-
University of PennsylvaniaActive, not recruitingAcute Myeloid Leukemia, in Relapse | Acute Myeloid Leukemia, Refractory | Acute Myeloid Leukemia, PediatricUnited States
-
Terrence J Bradley, MDImago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New...RecruitingAcute Myeloid Leukemia | Refractory Acute Myeloid Leukemia | Acute Myeloid Leukemia, in RelapseUnited States
-
Bhavana BhatnagarCTI BioPharmaCompletedRecurrent Adult Acute Myeloid Leukemia | Secondary Acute Myeloid Leukemia | Untreated Adult Acute Myeloid Leukemia | Therapy-Related Acute Myeloid LeukemiaUnited States
-
Washington University School of MedicineWithdrawnRefractory Acute Myeloid Leukemia | Relapsed Acute Myeloid LeukemiaUnited States
-
C. Babis AndreadisGateway for Cancer Research; AVEO Pharmaceuticals, Inc.TerminatedAcute Myeloid Leukemia | Refractory Acute Myeloid Leukemia | Relapsed Acute Myeloid LeukemiaUnited States
-
National Cancer Institute (NCI)RecruitingAcute Myeloid Leukemia | Secondary Acute Myeloid Leukemia | Recurrent Acute Myeloid Leukemia | Refractory Acute Myeloid LeukemiaUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)RecruitingAcute Myeloid Leukemia | Recurrent Adult Acute Myeloid Leukemia | Secondary Acute Myeloid Leukemia | Refractory Acute Myeloid LeukemiaUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingAcute Myeloid Leukemia | Secondary Acute Myeloid Leukemia | Untreated Adult Acute Myeloid Leukemia | Recurrent Acute Myeloid Leukemia | Refractory Acute Myeloid Leukemia | Therapy-Related Acute Myeloid LeukemiaUnited States
-
Jacqueline Garcia, MDEli Lilly and CompanyCompletedCombination Merestinib and LY2874455 for Patients With Relapsed or Refractory Acute Myeloid LeukemiaRelapsed Adult Acute Myeloid Leukemia | Refractory Adult Acute Myeloid LeukemiaUnited States
-
Kronos BioActive, not recruitingAcute Myeloid Leukemia | Refractory Acute Myeloid Leukemia | Relapsed Acute Myeloid LeukemiaUnited States, Spain
Clinical Trials on Donor Search Prognosis Score
-
Sun Yat-sen UniversityRecruitingHepatocellular CarcinomaChina
-
AfterROSCRecruiting
-
AfterROSCCompleted
-
University Hospitals Cleveland Medical CenterCompleted
-
Madigan Army Medical CenterUnknownLow Back Pain | Myofascial Pain Syndrome Lower BackUnited States