Results of Pre-MEASURE Study By NMDP/Be The Match, CIBMTR, and the NHLBI Published in JAMA

 // News

March 10  

The Pre-MEASURE study was a multicenter evaluation of the prognostic significance of measurable residual disease testing prior to allogeneic transplantation for adult patients with AML in first remission.

MINNEAPOLIS, MINN., March 7, 2023 – The National Marrow Donor Program® (NMDP)/Be The Match® in partnership with CIBMTR® (Center for International Blood and Marrow Transplant Research®) and the National Institute of Health’s National Heart, Lung, and Blood Institute (NHLBI) announced that the Journal of the American Medical Association (JAMA) published findings from the Pre-MEASURE study. The research explores a standardized method of assessing measurable residual disease (MRD) before allogeneic hematopoietic stem cell transplantation (HCT) in patients with acute myeloid leukemia (AML). It provides valuable insight into MRD as a predictive tool to inform HCT decisions and individualize treatment to improve outcomes.

“Allogeneic transplant is already an important treatment for many patients with AML. Unlocking the potential of precision medicine to improve it further will require a firm foundation of evidence. This Pre-MEASURE study demonstrates that it would be possible, using a blood test before transplant, to identify patients who may benefit from additional therapy beyond the current standard of care,” said Christopher Hourigan, DM, DPhil, FRCP, Chief of the Laboratory of Myeloid Malignancies, NHLBI.

The Pre-MEASURE study is the largest cohort of next-generation sequencing-based MRD testing (NGS-MRD) prior to allogeneic HCT for AML to date. It confirmed the ability to identify patients in complete remission (CR1) but at high risk of subsequent relapse using NGS-MRD testing pre-transplant. In addition, it found that reduced-intensity conditioning (RIC) was associated with a higher risk of relapse in those testing NGS-MRD positive. The research was conducted collaboratively by NMDP/Be The Match, CIBMTR, and NHLBI.

“NMDP/Be The Match is dedicated to ensuring that patients thrive following transplant. By developing standardized approaches for monitoring MRD before and after allogeneic HCT for AML allows physicians to create a personalized treatment approach that offers the best chances for success following HCT,” said Jeffery J. Auletta, MD, Senior Vice President, Patient Outcomes and Experience, NMDP/Be The Match; Chief Scientific Director, CIBMTR-NMDP; and Scientific Director, CIBMTR CRO Services. “We’re fortunate to have supported the Pre-MEASURE study featured in the Journal of The American Medical Association and to share the study’s findings for the benefit of patients everywhere. We are also supporting the forthcoming MEASURE study, which will standardize and optimize post-HCT MRD detection.”

In the Pre-MEASURE study, the team used ultra-deep error-corrected NGS techniques at a centralized NHLBI laboratory to determine if patients in clinical complete remission had MRD detectable by NGS-MRD before transplant, and how this was associated with outcomes for patients after transplant. Detection of persistent NPM1 and/or FLT3-ITD mutations was observed in 17.3% of patients (approximately 1 in 6) before transplant and was associated with significantly increased relapse and worse survival after transplant. Detecting MRD before transplant helps transplant teams identify patients at greater risk of relapse. Transplant teams could, in the future, alter the treatment plan for those patients to give them the best possible chance of optimal outcomes. The findings of this research provide evidence in support of a precision medicine approach for adult patients with AML undergoing transplant and are currently being implemented in a prospective clinical protocol at transplant centers throughout the United States.

The study was also presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting in June 2022. (Dillon LW, Gui G, Page KM, et al. DNA sequencing to detect residual disease in adults with acute myeloid leukemia prior to hematopoietic cell transplant. JAMA. 2023; DOI: 10.1001/jama.2023.1363)

The study was partially funded by the NHLBI of the National Institutes of Health (NIH) and the NIH Director’s Challenge Innovation Award. The Center for International Blood and Marrow Transplant Research (CIBMTR) is supported primarily by Public Health Service grant U24CA076518 from the National Cancer Institute (NCI) NHLBI and the National Institute of Allergy and Infectious Diseases (NIAID) of NIH, as well as by grants U24HL138660 and U24HL157560 from NHLBI and NCI, grant U24CA233032 from NCI, and grants OT3HL147741 and U01HL128568 from NHLBI. This content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

About the National Marrow Donor Program® (NMDP)/Be The Match®

The National Marrow Donor Program® (NMDP)/Be The Match® is the leading global partner working to save lives through cellular therapy. With 35 years of experience managing the most diverse registry of potential unrelated blood stem cell donors and cord blood units in the world, NMDP/Be The Match is a proven partner in providing cures to patients with life-threatening blood and marrow cancers and diseases. Through their global network, they connect centers and patients to their best cell therapy option—from blood stem cell transplant to a next-generation therapy—and collaborate with cell and gene therapy companies to support therapy development and delivery through Be The Match BioTherapies®. NMDP/Be The Match is a tireless advocate for the cell therapy community, working with hematologists/oncologists to remove barriers to consultation and treatment, and supporting patients through no-cost programs to eliminate non-medical obstacles to cell therapy. In addition, they are a global leader in research through CIBMTR® (Center for International Blood and Marrow Transplant Research®)—a collaboration with the Medical College of Wisconsin, investing in and managing research studies that improve patient outcomes and advance the future of care.

About CIBMTR

Center for International Blood and Marrow Transplant Research® (CIBMTR) is a nonprofit research collaboration between the National Marrow Donor Program (NMDP)/Be The Match, in Minneapolis, and the Medical College of Wisconsin, in Milwaukee. CIBMTR collaborates with the global scientific community to increase survival and enrich quality of life for patients. CIBMTR facilitates critical observational and interventional research through scientific and statistical expertise, a large network of centers, and a unique database of long-term clinical data for more than 630,000 people who have received hematopoietic cell transplantation and other cellular therapies. Learn more at cibmtr.org or follow the CIBMTR on Facebook, LinkedIn, or Twitter.

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