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The study was stopped due to exhaustion of funding. No additional financial support could be obtained to continue study operations as planned.
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| Name | Class |
|---|---|
| National Marrow Donor Program | OTHER |
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Prospective determination of the clinical utility of measurable residual disease (MRD) testing for relapse and survival of patients with acute myeloid leukemia (AML) undergoing allogeneic hematopoietic cell transplantation (alloHCT).
This is a multi-center non-randomized prospective study designed to establish a national framework for introducing measurable residual disease testing into the clinical care of AML patients undergoing allogeneic transplantation.
Enrollment is expected to occur over a 4-year period, with an additional 3 years of follow-up. Subject participation this study will be approximately 3 years. Up to 1,000 subjects will be enrolled.
Subjects will be asked to provide blood samples at months 1-6, 9, 12, 15, and 18 post-transplant, and archived specimens from time of AML diagnosis and any bone marrow samples collected for clinical purposes will be requested for research testing. Additional blood and marrow samples will be requested at relapse (if applicable).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult patients with AML in complete remission undergoing alloHCT | Adult patients with AML in complete remission undergoing alloHCT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prospective determination of the clinical utility of measurable residual disease (MRD) testing | Other | Prospective determination of the clinical utility of measurable residual disease (MRD) testing for relapse and survival of patients with acute myeloid leukemia (AML) undergoing allogeneic hematopoietic cell transplantation (alloHCT). |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival post-alloHCT via comparison between those testing positive or negative using an optimized molecular monitoring approach. | Through up to 3 years post-alloHCT |
| Cumulative incidence of relapse | Cumulative incidence of relapse post-alloHCT via comparison between those testing positive or negative using an optimized molecular monitoring approach. | Through up to 3 years post-alloHCT |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse Prediction - Testing Approaches | Proportion of post-alloHCT relapses identified by different MRD testing approaches with optimal test thresholds at peri-transplant timepoints. | Through up to 3 years post-alloHCT |
| Relapse Prediction - Pre-Transplant Testing |
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Inclusion Criteria:
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Aged at least 18 years old at time of consent
Diagnosed with AML, in complete remission
Undergoing alloHCT
Has a diagnostic AML specimen available
Exclusion Criteria:
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Adult patients with AML in complete remission undergoing alloHCT
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Hourigan, DM, D.Phil. | Virginia Polytechnic Institute and State University | Study Chair |
| Jeffrey Auletta, MD | National Marrow Donor Program | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | United States | ||
| University of California, San Francisco |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 1, 2024 | Jan 17, 2025 |
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Blood, Bone Marrow (if collected for clinical purposes only), archived specimens from time of AML diagnosis (diagnosis specimens include: bone marrow aspirate cells, extracted DNA, marrow aspirate pellet, marrow aspirate slides, blood)
|
Proportion of post-alloHCT relapses predicted by pre-transplant testing (comparing blood with marrow when available). |
| Through up to 3 years post-alloHCT |
| Relapse Prediction - Early Prediction | Proportion of post-alloHCT relapses identified one month or more earlier than local testing by post-alloHCT optimized monitoring. | Through up to 3 years post-alloHCT |
| Relapse Prediction - Time to Relapse | Time from testing positive by optimized monitoring to relapse. | Through up to 3 years post-alloHCT |
| Biology of Relapse - Change in Genetic Profile | for subjects with relapse sample available) - Proportion of relapses with change in genetic profile to diagnosis. | Through up to 3 years post-alloHCT |
| Biology of Relapse - Change in Immunophenotype | (for subjects with relapse sample available) - Proportion of relapses with change in immunophenotype to diagnosis. | Through up to 3 years post-alloHCT |
| Biology of Relapse - HLA Loss | (for subjects with relapse sample available) - Proportion of relapses with evidence of human leukocyte antigen (HLA) loss. | Through up to 3 years post-alloHCT |
| San Francisco |
| California |
| 94143 |
| United States |
| Stanford University | Stanford | California | 94305 | United States |
| University of Colorado | Aurora | Colorado | 80045 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| H. Lee Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| Northside Hospital | Atlanta | Georgia | 30342 | United States |
| University of Chicago Medicine | Chicago | Illinois | 60637 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Roswell Park Comprehensive Cancer Center | Buffalo | New York | 14263 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10021 | United States |
| New York Presbyterian / Weill Cornell Medical Center | New York | New York | 10021 | United States |
| Levine Cancer Institute | Charlotte | North Carolina | 28204 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| The Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Fred Hutchinson Cancer Center | Seattle | Washington | 98109 | United States |
| ICF_000.pdf |