MRD Testing for AML

(MEASURE Trial)

Not currently recruiting at 17 trial locations

Overseen By Study Inbox

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Center for International Blood and Marrow Transplant Research

Disqualifiers: Acute promyelocytic leukemia, prior alloHCT

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how measurable residual disease (MRD) testing can predict the recurrence of acute myeloid leukemia (AML) after a stem cell transplant. It focuses on individuals with AML who are in complete remission and are planning to undergo an allogeneic hematopoietic cell transplant (a donor stem cell transplant). Those treated for AML and preparing for this type of transplant may find this study suitable. The goal is to enhance understanding of relapse and survival rates using this testing method. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to significant findings.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that MRD testing is safe for patients with AML undergoing alloHCT?

Research shows that testing for measurable residual disease (MRD) in patients with acute myeloid leukemia (AML) is generally safe. Studies have found that patients with no detectable MRD have a lower chance of cancer recurrence and tend to live longer. This indicates that the testing process itself is not harmful. MRD testing helps doctors assess how much cancer remains after treatment, guiding further care. The process involves taking blood or bone marrow samples, and no major side effects have been reported. Overall, MRD testing is well-tolerated and provides important information for managing AML. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about measurable residual disease (MRD) testing for acute myeloid leukemia (AML) patients because it offers a new way to predict and monitor relapse after a stem cell transplant. Unlike traditional methods that may only detect relapse once symptoms appear or when it's too late for early intervention, MRD testing can identify tiny amounts of cancer cells that remain in the body. This gives doctors a chance to act sooner, potentially improving outcomes by catching relapses early and tailoring treatment plans more effectively.

What evidence suggests that MRD testing is effective for AML?

Research has shown that testing for measurable residual disease (MRD) can benefit patients with acute myeloid leukemia (AML). In previous studies, up to 84% of patients achieved MRD-negative status, indicating no detectable signs of the disease. Those who reached this status often lived longer, with some studies reporting a 67% survival rate over a certain period. This trial will use MRD testing to assess its clinical utility for adult patients with AML in complete remission undergoing alloHCT. MRD testing is highly sensitive and can detect tiny amounts of cancer cells that traditional tests might miss. This makes it a promising method to predict relapse and improve survival chances for AML patients undergoing stem cell transplants. ^{2 3 4 6 7}

Who Is on the Research Team?

Christopher Hourigan, DM, D.Phil.

Principal Investigator

Virginia Polytechnic Institute and State University

Jeffrey Auletta, MD

Principal Investigator

National Marrow Donor Program

Are You a Good Fit for This Trial?

Inclusion Criteria

Complete remission (CR) definition per local institutional criteria

Has specimen from time of AML diagnosis available

Provision of signed and dated informed consent form

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Transplantation

Participants undergo allogeneic hematopoietic cell transplantation (alloHCT)

1 week

Post-Transplant Monitoring

Participants provide blood samples at months 1-6, 9, 12, 15, and 18 post-transplant for MRD testing

18 months

Multiple visits for blood sample collection

Follow-up

Participants are monitored for relapse and survival outcomes

3 years

What Are the Treatments Tested in This Trial?

Interventions

• Prospective determination of the clinical utility of measurable residual disease (MRD) testing

How Is the Trial Designed?

Group I: Adult patients with AML in complete remission undergoing alloHCT Experimental Treatment 1 Intervention

Adult patients with AML in complete remission undergoing alloHCT

Who Is Running the Clinical Trial?

Center for International Blood and Marrow Transplant Research

Lead Sponsor

Trials

40

Recruited

200,190,000+

National Marrow Donor Program

Collaborator

Trials

63

Recruited

202,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10841357/

Measurable Residual Disease Monitoring in Patients with ... The percentage of patients who could be analyzed for MRD ranged from 42 to 100%. Using MFC-MRD, 18 to 84% of patients were MRD negative at time of achievement ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0037196325000290

Measurable residual disease monitoring in acute myeloid ... After 2 cycles, 69% achieved MRD-response (95% CI: 49%-83%), and at a median follow-up of 25 months, median OS had not been reached (OS 67%; 95% ...

3. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.35960

Measurable residual disease (MRD) as a surrogate end point ... Measurable residual disease (MRD) may have the potential to serve as a surrogate end point for OS in AML. MRD is the detection of phenotypic or ...

4. nature.com nature.com/articles/s41409-024-02493-y

Molecular MRD testing in patients with acute myeloid ... The qPCR assay for MRD is highly sensitive and able to detect ~1/100,000 events compared to MFC with a sensitivity of only ~1/1000 with greater ...

5. ashpublications.org ashpublications.org/bloodadvances/article/9/4/783/534322/Impact-of-measurable-residual-disease-clearance

Impact of measurable residual disease clearance kinetics in ... Rates of MRD Neg/Neg for favorable-, intermediate-, and adverse-risk patients were 74%, 79%, and 48%, respectively. Thirty-three percent of ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK586210/

Measurable Residual Disease Testing in Acute Leukemia Patients with undetectable MRD or good MRD response consistently demonstrate a lower risk of relapse and better survival outcomes compared with similarly ...

7. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(25)00280-9/fulltext

Measurable residual disease in hematologic malignancies MRD positivity signifies residual disease and worse outcomes, while MRD negativity suggests a lower or absent disease burden (depending on the sensitivity of ...