Minimal Residual Disease Testing in Acute Leukemia

Guideline Objective:

To provide evidence surrounding the clinical utility of minimal/measurable residual disease (MRD) testing using multiparameter flow cytometry (MFC), next-generation sequencing (NGS), or polymerase chain reaction (PCR)-based methods in patients with acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML).

Patient Population:

Adult patients with a diagnosis of acute leukemia (i.e., AML or ALL).

Intended Guideline Users:

This guideline is targeted for:

• Clinicians, laboratory physicians, and scientists involved in the care and testing of patients with acute leukemia.
• Policy makers, health care administrators, and the Ontario Ministry of Health.

Research Questions:

1. What benefit to clinical management does MRD testing contribute in the treatment of patients with ALL?
   1. If positive at a certain time point, does a change in treatment alter patient outcomes?
   2. If positive before transplant, does a delay in stem cell transplant and change in treatment, to achieve MRD negativity, alter patient outcomes?
   3. If positive before transplant and negativity is achieved, are patient outcomes different?
2. What benefit to clinical management does MRD testing contribute in the treatment of patients with AML?
   1. If positive at a certain time point, does change in treatment alter patient outcomes?
   2. If positive before transplant, does a delay in stem cell transplant and change in treatment, to achieve MRD negativity, alter patient outcomes?
   3. If positive before transplant and negativity is achieved, are patient outcomes different?