Next-Generation Sequencing Monitoring and Risk-Based Management After CD19 CART Therapy in Children and Young Adults With B-Cell Acute Lymphoblastic Leukemia

What this Trial Is About

Researchers are investigating a new monitoring approach for children and young adults aged 1 to 25 with B-cell acute lymphoblastic leukemia B-ALL who have recently received chimeric antigen receptor T-cell CART therapy. This study aims to assess whether regular blood and bone marrow testing using next-generation sequencing NGS can help predict relapse after CART treatment and guide decisions about additional therapies like stem cell transplant HCT. Participants will undergo frequent clinic visits every two weeks starting 42 days after CART therapy, with blood samples collected at each visit. Bone marrow biopsies will be performed at four routine timepoints to gather tissue samples. The study uses advanced biomarker tests, including ClonoSEQ and NGS, to monitor remission status and B-cell recovery, helping to identify which patients may benefit from further treatment such as HCT. During the two-year study period, participants will experience regular assessments, including blood draws and bone marrow sampling. Researchers will evaluate the effectiveness of this biomarker-guided strategy by monitoring outcomes like relapse timing, need for HCT, leukemia-free survival, and overall survival. The study also tracks functional CART persistence and aims to improve long-term remission management for patients who have undergone CART therapy.

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 Lymph...