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Molecular Evaluation of AML Patients After Stem Cell Transplant to Understand Relapse Events (MEASURE)

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ClinicalTrials.gov Identifier: NCT05224661
Recruitment Status : Recruiting
First Posted : February 4, 2022
Last Update Posted : July 3, 2023
Sponsor:
Collaborator:
National Marrow Donor Program
Information provided by (Responsible Party):
Center for International Blood and Marrow Transplant Research

Study Description
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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).

Condition or disease Intervention/treatment
Acute Myeloid Leukemia in Remission Other: Prospective determination of the clinical utility of measurable residual disease (MRD) testing

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).

Study Design
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Molecular Evaluation of AML Patients After Stem Cell Transplant to Understand Relapse Events
Actual Study Start Date : August 26, 2022
Estimated Primary Completion Date : July 1, 2029
Estimated Study Completion Date : July 1, 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

Groups and Cohorts
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Group/Cohort Intervention/treatment
Adult patients with AML in complete remission undergoing alloHCT
Adult patients with AML in complete remission undergoing alloHCT
 Other: Prospective determination of the clinical utility of measurable residual disease (MRD) testing
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).


Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival [ Time Frame: Through up to 3 years post-alloHCT ]
    Overall survival post-alloHCT via comparison between those testing positive or negative using an optimized molecular monitoring approach.

  2. Cumulative incidence of relapse [ Time Frame: Through up to 3 years post-alloHCT ]
    Cumulative incidence of relapse post-alloHCT via comparison between those testing positive or negative using an optimized molecular monitoring approach.


Secondary Outcome Measures :
  1. Relapse Prediction - Testing Approaches [ Time Frame: Through up to 3 years post-alloHCT ]
    Proportion of post-alloHCT relapses identified by different MRD testing approaches with optimal test thresholds at peri-transplant timepoints.

  2. Relapse Prediction - Pre-Transplant Testing [ Time Frame: Through up to 3 years post-alloHCT ]
    Proportion of post-alloHCT relapses predicted by pre-transplant testing (comparing blood with marrow when available).

  3. Relapse Prediction - Early Prediction [ Time Frame: Through up to 3 years post-alloHCT ]
    Proportion of post-alloHCT relapses identified one month or more earlier than local testing by post-alloHCT optimized monitoring.

  4. Relapse Prediction - Time to Relapse [ Time Frame: Through up to 3 years post-alloHCT ]
    Time from testing positive by optimized monitoring to relapse.

  5. Biology of Relapse - Change in Genetic Profile [ Time Frame: Through up to 3 years post-alloHCT ]
    for subjects with relapse sample available) - Proportion of relapses with change in genetic profile to diagnosis.

  6. Biology of Relapse - Change in Immunophenotype [ Time Frame: Through up to 3 years post-alloHCT ]
    (for subjects with relapse sample available) - Proportion of relapses with change in immunophenotype to diagnosis.

  7. Biology of Relapse - HLA Loss [ Time Frame: Through up to 3 years post-alloHCT ]
    (for subjects with relapse sample available) - Proportion of relapses with evidence of human leukocyte antigen (HLA) loss.


Biospecimen Retention:   Samples With DNA
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)

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with AML in complete remission undergoing alloHCT
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 specimen from time of AML diagnosis available

Exclusion Criteria:

  1. Diagnosis of acute promyelocytic leukemia
  2. Prior alloHCT
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05224661


Contacts
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Contact: Jenny Vogel 763-406-8691 JVogel@NMDP.org
Contact: Study Inbox MEASURE@NMDP.org

Locations
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United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Amandeep Salhotra, MD         
Principal Investigator: Amandeep Salhotra, MD         
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Aaron Logan, MD, PhD         
Principal Investigator: Aaron Logan, MD, PhD         
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Lori Muffly, MD         
Principal Investigator: Lori Muffly, MD         
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Antonio Jimenez Jimenez, MD         
Principal Investigator: Antonio Jimenez Jimenez, MD         
H. Lee Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Nelli Bejanyan, MD         
Principal Investigator: Nelli Bejanyan, MD         
United States, Georgia
Northside Hospital Recruiting
Atlanta, Georgia, United States, 30342
Contact: Melhem Solh, MD         
Principal Investigator: Melhem Solh, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Yi-Bin Chen, MD         
Principal Investigator: Yi-Bin Chen, MD         
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Christopher Gibson, MD         
Principal Investigator: Christopher Gibson, MD         
United States, New York
Roswell Park Comprehensive Cancer Center Recruiting
Buffalo, New York, United States, 14263
Contact: Elizabeth Griffiths, MD         
Principal Investigator: Elizabeth Griffiths, MD         
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Brian Shaffer, MD         
Principal Investigator: Brian Shaffer, MD         
New York Presbyterian / Weill Cornell Medical Center Recruiting
New York, New York, United States, 10021
Contact: Alexandra Gomez Arteaga, MD         
Principal Investigator: Alexandra Gomez Arteaga, MD         
United States, North Carolina
Levine Cancer Institute Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Michael Grunwald, MD         
Principal Investigator: Michael Grunwald, MD         
United States, Washington
Fred Hutchinson Cancer Center Recruiting
Seattle, Washington, United States, 98109
Contact: Elizabeth Krakow, MD         
Principal Investigator: Elizabeth Krakow, MD         
Sponsors and Collaborators
Center for International Blood and Marrow Transplant Research
National Marrow Donor Program
Investigators
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Study Chair: Christopher Hourigan, DM, D.Phil. National Institutes of Health (NIH)
Study Chair: Jeffrey Auletta, MD National Marrow Donor Program
More Information
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Responsible Party: Center for International Blood and Marrow Transplant Research
ClinicalTrials.gov Identifier: NCT05224661    
Other Study ID Numbers: MEASURE
First Posted: February 4, 2022    Key Record Dates
Last Update Posted: July 3, 2023
Last Verified: June 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No