Biomarkers Consortium - Minimal Residual Disease (MRD) Detection in Adult Acute Lymphoblastic Leukemia (ALL)

Minimal residual disease (MRD) is the amount of disease detected by molecular or cellular means when the patient is in a clinical and pathological state of remission after treatment of leukemia. The goals of this project are to assess whether MRD may be an endpoint for use as a DDT and to standardize MRD measurement in adult precursor B-lineage ALL.


  • Evaluate existing data to determine the utility of MRD for predicting event-free survival (EFS) in pediatric and adult ALL.
  • Standardize MRD testing in Intergroup labs and export standardization to the community.

Results & Accomplishments

Guidance Documents

Scientific Publications



This project completed in December 2019.

Leukemias are life-threatening, but treatable, cancers of the blood or bone marrow resulting in abnormally high numbers of immature white blood cells. Minimal residual disease (MRD) is the number of leukemic cells detected in the blood or bone marrow of a patient in a state of remission after treatment is completed. MRD has been investigated extensively in pediatric acute lymphoblastic leukemia (ALL), and its detection is associated with subsequent relapse, event-free or relapse-free survival (EFS or RFS, respectively). However, data concerning the association of MRD to outcomes in adult ALL have not been as well investigated. The goal of the Minimal Residual Disease Detection in Adult Acute Lymphoblastic Leukemia project is to establish MRD as an indicator of clinical outcomes in adult ALL. An additional goal of the project is to standardize methodologies used for laboratory analyses of MRD. The project, supported through the Biomarkers Consortium and conducted and funded by a number of collaborating institutions as members of the project team, launched in late 2014.

A trial level meta-analysis from published data conducted by the MRD in All team suggests high correlation between EFS and MRD and that MRD has potential to be a surrogate endpoint for ALL. However, a more detailed analysis of the data will need to be conducted to prove MRD’s surrogacy in ALL. The FDA will lead a patient level analysis as a next step in this qualification process, and this work is currently ongoing. In addition, the team continues to work on developing better flow cytometry assays for the detection of MRD in ALL and hopes to eventually have these kits approved by the FDA.


Public-Sector Partners:

  • National Cancer Institute (NCI)
  • U.S. Food and Drug Administration (FDA)

Private-Sector Partners:

  • AbbVie Inc.*
  • Amgen, Inc.*
  • BD Biosciences, Becton Dickinson and Company*
  • Beckman Coulter, Beckman Coulter Life Sciences*
  • Genentech, a member of the Roche Group*
  • Pfizer Inc*

Academic Partners:

  • Hartford Health Hospital
  • Johns Hopkins University
  • Lawson Health Research Institute
  • MD Anderson Cancer Center
  • Montefiore Medical Center
  • Ohio State University
  • University of Washington
  • Vanderbilt University

*Provided financial or in-kind support for this program.

FNIH Contact

  • Stacey J. Adam, Ph.D., Associate Vice President, Research Partnerships;