Overview
Acute myeloid leukemia (AML) is a heterogeneous genetic disease. According to the National Cancer Institute (NCI), an estimated 20,240 new AML cases were diagnosed in the United States in 2021, and the five-year survival rate is less than 30% across all age groups1. The biomarkers of measurable residual disease (MRD) cover a variety of mutations, which may occur at different frequencies at diagnosis and during therapy. This project will pioneer sensitive, reproducible, and robust platforms for the measurement of MRD, which can be used to establish it as a validated surrogate endpoint for use in clinical trials. As MRD is increasingly incorporated into clinical trials and real-time patient management, validated biomarkers will support improved patient care and enhance development of novel therapies.
MRD Detection as a Strong Predictor of Relapse
Relapse from stable disease while on treatment is the primary obstacle to curing acute and chronic leukemia in the clinical setting. The detection of MRD following treatment is a direct measure of disease burden and the strongest predictor of relapse. MRD currently guides treatment decisions and is an established clinical trial endpoint in chronic myeloid leukemia (CML), and recent collaborative efforts have demonstrated its importance in acute lymphoblastic leukemia (ALL). In acute myeloid leukemia (AML) patients, the detection of MRD is also strongly associated with relapse, but it is technically more difficult to perform and standardize in AML than in CML or ALL and has not yet been integrated into clinical trial design and outcome. This project addresses that unmet need and will develop, validate, and integrate molecular diagnostics into existing AML trials and therapy.
The Problem
Detection of measurable residual disease (MRD) is a strong predictor of relapse in acute and chronic leukemia, but its integration into clinical trial designs and outcome measures for acute myeloid leukemia (AML) has not been standardized.
The Solution
Partners
| What The Partners are Saying |
Public-Sector Partners
- National Cancer Institute (NCI)
- National Heart Lung and Blood Institute (NHLBI)
- U.S. Food and Drug Administration (FDA)
Private-Sector Partners
- AbbVie*
- Amgen*
- AccuGenomics, Inc*
- AstraZeneca*
- Bio-Rad Laboratories Inc., Digital Biology Group*
- Genentech, a member of the Roche Group*
- Gilead Sciences, Inc.*
- GlaxoSmithKline*
- Invivoscribe, Inc.*
- Jazz Pharmaceuticals, Inc.*
- LGC Clinical Diagnostics, Inc.*
- Mission Bio*
- Novartis*
- Syndax Pharmaceuticals, Inc.*
- Sysmex Inostics, Inc.*
- 10x Genomics, Inc.*
- Takeda*
- Thermo Fisher Scientific*
- TwinStrand Biosciences, Inc*
- Twist Bioscience Corporation*
Academic Partners
- Dana-Farber Cancer Institute
- Fred Hutchinson Cancer Research Center
- Virginia Tech Fralin Biomedical Research Institute Cancer Research Center