A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults with B Lineage Acute Lymphoblastic Leukemia
CAR-CURE
What is the goal of the study?
To assess effectiveness of a new biomarker-guided risk-based strategy to monitor remission, both by testing for functional CART persistence and incorporating antigen immunophenotype agnostic approach (NGS monitoring) for disease detection, to inform decisions regarding post-CART HCT needed intervention, and to successfully collect biomarker samples at the scheduled times in enrolled HCT naïve B-ALL participants receiving CD19 CART.
Who can participate in the study?
Participants age 1-25 at the time of CAR T cell infusion with a diagnosis of CD19+ B cell ALL, and are in MRD negative complete remission within 42 days after CAR T cell infusion. Participants must have allogeneic hematopoietic cell transplant donor identified for potential hematopoietic cell transplant