Clinical trial NCT05224661: Molecular Evaluation of AML Patients After Stem Cell Transplant to Understand Relapse Events
Official title: Molecular Evaluation of AML Patients After Stem Cell Transplant to Understand Relapse Events
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Acute Myeloid Leukemia in Remission
Lead sponsor: Center for International Blood and Marrow Transplant Research
Sponsor class: NETWORK
Collaborators: name: National Marrow Donor Program
First posted: 2022-02-04
Enrollment: 303
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with AML in complete remission undergoing alloHCT

Brief summary: 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).

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Aged at least 18 years old at time of consent
4. Diagnosed with AML, in complete remission

   1. Complete remission (CR) definition per local institutional criteria
   2. CR with incomplete hematologic recovery (CRi) is not an exclusion criterion
   3. MRD positivity is not an exclusion criterion
5. Undergoing alloHCT
6. Has a diagnostic AML specimen available

Exclusion Criteria:

1. Diagnosis of acute promyelocytic leukemia
2. Prior alloHCT

Primary outcomes:
measure: Overall Survival
timeFrame: Through up to 3 years post-alloHCT
measure: Cumulative incidence of relapse
timeFrame: Through up to 3 years post-alloHCT
Secondary outcomes:
measure: Relapse Prediction - Testing Approaches
timeFrame: Through up to 3 years post-alloHCT
measure: Relapse Prediction - Pre-Transplant Testing
timeFrame: Through up to 3 years post-alloHCT
measure: Relapse Prediction - Early Prediction
timeFrame: Through up to 3 years post-alloHCT
measure: Relapse Prediction - Time to Relapse
timeFrame: Through up to 3 years post-alloHCT
measure: Biology of Relapse - Change in Genetic Profile
timeFrame: Through up to 3 years post-alloHCT
measure: Biology of Relapse - Change in Immunophenotype
timeFrame: Through up to 3 years post-alloHCT
measure: Biology of Relapse - HLA Loss
timeFrame: Through up to 3 years post-alloHCT
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center
state: Florida
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medicine
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Buffalo
country: United States
facility: Roswell Park Comprehensive Cancer Center
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: New York Presbyterian / Weill Cornell Medical Center
state: New York
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Comprehensive Cancer Center
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Center
state: Washington
Study officials:
affiliation: Virginia Polytechnic Institute and State University
name: Christopher Hourigan, DM, D.Phil.
role: STUDY_CHAIR
affiliation: National Marrow Donor Program
name: Jeffrey Auletta, MD
role: STUDY_CHAIR
References: