Acute Myeloid Leukemia in RemissionMEASURENCT05224661
Molecular Evaluation of AML Patients After Stem Cell Transplant to Understand Relapse Events
An observational study of Acute Myeloid Leukemia in Remission, run by Center for International Blood and Marrow Transplant Research at 18 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia in Remission
- What is being tested?
- Prospective determination of the clinical utility of measurable residual disease (MRD) testing
- How many people
- 303 participants
- Where
- 18 sitesUnited States
- Study dates
- 26 Aug 2022to 12 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with AML in complete remission undergoing alloHCT
Who may be able to join
- 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
- Complete remission (CR) definition per local institutional criteria
- CR with incomplete hematologic recovery (CRi) is not an exclusion criterion
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- MRD positivity is not an exclusion criterion
- Undergoing alloHCT
- Has a diagnostic AML specimen available
Who cannot join
- Diagnosis of acute promyelocytic leukemia
- Prior alloHCT
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Northside Hospital
Atlanta, Georgia, 30342
University of Colorado
Aurora, Colorado, 80045
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263
Levine Cancer Institute
Charlotte, North Carolina, 28204
University of Chicago Medicine
Chicago, Illinois, 60637
Cleveland Clinic
Cleveland, Ohio, 44195
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
City of Hope
Duarte, California, 91010
University of Miami
Miami, Florida, 33136
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
New York Presbyterian / Weill Cornell Medical Center
New York, New York, 10021
University of California, San Francisco
San Francisco, California, 94143
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Stanford University
Stanford, California, 94305
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612
About this study
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).
Read the 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).
- Conditions
- Acute Myeloid Leukemia in Remission
- Being tested
- Prospective determination of the clinical utility of measurable residual disease (MRD) testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prospective determination of the clinical utility of measurable residual disease (MRD) testingOther
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 group | Role | What they receive |
|---|---|---|
| Adult patients with AML in complete remission undergoing alloHCT | Adult patients with AML in complete remission undergoing alloHCT Receives: Other: Prospective determination of the clinical utility of measurable residual disease (MRD) testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Overall survival post-alloHCT via comparison between those testing positive or negative using an optimized molecular monitoring approach.
Measured: 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.
Measured: Through up to 3 years post-alloHCT
Secondary outcomes (7)
Relapse Prediction - Testing Approaches
Proportion of post-alloHCT relapses identified by different MRD testing approaches with optimal test thresholds at peri-transplant timepoints.
Measured: 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).
Measured: 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.
Measured: Through up to 3 years post-alloHCT
Relapse Prediction - Time to Relapse
Time from testing positive by optimized monitoring to relapse.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through up to 3 years post-alloHCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start26 Aug 2022
- Primary completion12 Dec 2025
- Study completion12 Dec 2025
Why it stopped: The study was stopped due to exhaustion of funding. No additional financial support could be obtained to continue study operations as planned.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia in RemissionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for International Blood and Marrow Transplant Research
- Sponsor type
- Research network
- Collaborators
- National Marrow Donor Program
- Responsible party
- Sponsor
- Investigators
- Christopher Hourigan, DM, D.Phil., Study chair, Virginia Polytechnic Institute and State UniversityJeffrey Auletta, MD, Study chair, National Marrow Donor Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05224661
- Sponsor's protocol ID
- MEASURE
- Acronym
- MEASURE
- Status last verified
- May 2026
- First submitted
- 22 Nov 2021
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Evaluation of AML Patients After Stem Cell Transplant to Understand Relapse Events
- ClinicalTrials.gov ID
- NCT05224661
- Acronym / sponsor ID
- MEASURE / MEASURE
- Conditions
- Acute Myeloid Leukemia in Remission
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was stopped due to exhaustion of funding. No additional financial support could be obtained to continue study operations as planned.
- Enrolment
- 303 participants (actual)
- Lead sponsor
- Center for International Blood and Marrow Transplant ResearchResearch network
- Collaborators
- National Marrow Donor Program
- Study start
- 26 Aug 2022 (actual)
- Primary completion
- 12 Dec 2025 (actual)
- Study completion
- 12 Dec 2025 (actual)
- First posted
- 4 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients with AML in complete remission undergoing alloHCT | – | Other: Prospective determination of the clinical utility of measurable residual disease (MRD) testingAdult patients with AML in complete remission undergoing alloHCT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with AML in complete remission undergoing alloHCT
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (2 listed)
- Diagnosis of acute promyelocytic leukemia
- Prior alloHCT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prospective determination of the clinical utility of measurable residual disease (MRD) testingProspective 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). | Other | Adult patients with AML in complete remission undergoing alloHCT |
Primary outcome
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.
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.
7 secondary outcomes
Relapse Prediction - Testing Approaches
Time frame: Through up to 3 years post-alloHCT
Relapse Prediction - Pre-Transplant Testing
Time frame: Through up to 3 years post-alloHCT
Relapse Prediction - Early Prediction
Time frame: Through up to 3 years post-alloHCT
Relapse Prediction - Time to Relapse
Time frame: Through up to 3 years post-alloHCT
Biology of Relapse - Change in Genetic Profile
Time frame: Through up to 3 years post-alloHCT
Biology of Relapse - Change in Immunophenotype
Time frame: Through up to 3 years post-alloHCT
Biology of Relapse - HLA Loss
Time frame: Through up to 3 years post-alloHCT
Results and safety
The study was stopped early (reason given: The study was stopped due to exhaustion of funding. No additional financial support could be obtained to continue study operations as planned.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Hourigan, DM, D.Phil. study chair
Virginia Polytechnic Institute and State University
Jeffrey Auletta, MD study chair
National Marrow Donor Program
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia in Remission, run by Center for International Blood and Marrow Transplant Research at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was stopped due to exhaustion of funding. No additional financial support could be obtained to continue study operations as planned.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: Through up to 3 years post-alloHCT). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.