Risk-Based Treatment Outcomes in Children and Young Adults With Relapsed Acute Lymphoblastic Leukemia Evaluating NGS MRD-Guided Therapy

What this Trial Is About

Researchers are investigating treatments for children and young adults with relapsed acute lymphoblastic leukemia ALL, including cases with bone marrow recurrence. This phase 2, open-label, multi-center study evaluates outcomes based on risk groups determined by next-generation sequencing minimal residual disease NGS MRD after induction therapy. The risk groups are standard risk, high risk, and very high risk, with classification depending on specific leukemia types and MRD levels. Participants receive treatment plans tailored to their risk group, including combinations of chemotherapy drugs such as prednisolone, vincristine, L-asparaginase, idarubicin, methotrexate, and cytarabine, as well as blinatumomab therapy and hematopoietic stem cell transplantation when appropriate. Treatment phases include reinduction, consolidation, intensification, possible blinatumomab courses, and maintenance, following specific schedules lasting weeks to months depending on the regimen. Throughout the study, participants undergo regular assessments including blood tests, imaging, and performance status evaluations to monitor safety and treatment efficacy for an average of nine years. Outcomes measured include disease-free survival rates, treatment-related death and toxicity rates, and overall safety. The study requires compliance with protocol procedures and informed consent, with ongoing monitoring and care throughout participation.

Evaluation of Treatment Efficacy According to Risk Group in Relapsed Childhood Acute Lymphoblastic Leukemia