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

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).

Study Overview

• Status: Recruiting
• Conditions: Acute Myeloid Leukemia in Remission
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Study Inbox; Email: MEASURE@NMDP.org
• Study Contact Backup: Name: Jenny Vogel; Phone Number: 763-406-8691; Email: JVogel@NMDP.org

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • Recruiting
      • City of Hope
      • Contact: Amandeep Salhotra, MD
      • Principal Investigator: Amandeep Salhotra, MD
    • San Francisco, California, United States, 94143
      • Recruiting
      • University of California, San Francisco
      • Contact: Aaron Logan, MD, PhD
      • Principal Investigator: Aaron Logan, MD, PhD
    • Stanford, California, United States, 94305
      • Recruiting
      • Stanford University
      • Contact: Lori Muffly, MD
      • Principal Investigator: Lori Muffly, MD
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami
      • Contact: Antonio Jimenez Jimenez, MD
      • Principal Investigator: Antonio Jimenez Jimenez, MD
    • Tampa, Florida, United States, 33612
      • Recruiting
      • H. Lee Moffitt Cancer Center
      • Principal Investigator: Nelli Bejanyan, MD
      • Contact: Nelli Bejanyan, MD
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Recruiting
      • Northside Hospital
      • Contact: Melhem Solh, MD
      • Principal Investigator: Melhem Solh, MD
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • University of Chicago Medicine
      • Contact: Michael Drazer, MD, PhD
      • Principal Investigator: Michael Drazer, MD, PhD
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Yi-Bin Chen, MD
      • Principal Investigator: Yi-Bin Chen, MD
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Dana Farber Cancer Institute
      • Contact: Christopher Gibson, MD
      • Principal Investigator: Christopher Gibson, MD
  • New York
    • Buffalo, New York, United States, 14263
      • Recruiting
      • Roswell Park Comprehensive Cancer Center
      • Principal Investigator: Elizabeth Griffiths, MD
      • Contact: Elizabeth Griffiths, MD
    • New York, New York, United States, 10021
      • Recruiting
      • Memorial Sloan Kettering Cancer Center
      • Contact: Brian Shaffer, MD
      • Principal Investigator: Brian Shaffer, MD
    • New York, New York, United States, 10021
      • Recruiting
      • New York Presbyterian / Weill Cornell Medical Center
      • Contact: Alexandra Gomez Arteaga, MD
      • Principal Investigator: Alexandra Gomez Arteaga, MD
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Recruiting
      • Levine Cancer Institute
      • Contact: Michael Grunwald, MD
      • Principal Investigator: Michael Grunwald, MD
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic
      • Contact: Sophia Bladerman, MD
      • Principal Investigator: Sophia Balderman, MD
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • The Ohio State University Comprehensive Cancer Center
      • Principal Investigator: James Blachly, MD
      • Contact: James Blachly, MD
  • Washington
    • Seattle, Washington, United States, 98109
      • Recruiting
      • Fred Hutchinson Cancer Center
      • Contact: Elizabeth Krakow, MD
      • Principal Investigator: Elizabeth Krakow, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with AML in complete remission undergoing alloHCT

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Center for International Blood and Marrow Transplant Research
• Collaborators: National Marrow Donor Program
• Investigators: Study Chair: Christopher Hourigan, DM, D.Phil., National Institutes of Health (NIH); Study Chair: Jeffrey Auletta, MD, National Marrow Donor Program

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2022
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2029

Study Registration Dates

• First Submitted: November 22, 2021
• First Submitted That Met QC Criteria: January 25, 2022
• First Posted (Actual): February 4, 2022

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 2, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: MEASURE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No