Phase 1 Study of Hyper-CVAD and Venetoclax Combination for Children and Young Adults with Relapsed or Refractory Lymphoid Acute Leukemias

What this Trial Is About

Researchers are studying the combination of hyper-CVAD chemotherapy with the drug venetoclax in children and young adults aged 2 to 21 years who have relapsed or refractory acute leukemias of the lymphoid lineage, including bi-phenotypic or undifferentiated leukemias. This Phase I trial aims to find the highest safe dose of venetoclax that can be given with hyper-CVAD and to assess safety and early signs of effectiveness. Participants will be assigned to two phases Phase 1a tests increasing doses of venetoclax alongside standard hyper-CVAD chemotherapy to find the maximum tolerated dose. In Phase 1b, participants receive venetoclax at the recommended dose determined in Phase 1a, together with hyper-CVAD. Venetoclax is given by mouth, and hyper-CVAD is given intravenously, with dosing based on standard care. During the study, participants will be monitored for safety and side effects over about one year. Researchers will assess overall response to treatment, survival outcomes, and disease markers. Laboratory tests, including blood counts and organ function, will be conducted. Participants will also be evaluated for molecular and cellular responses to treatment. Ongoing monitoring will help understand the treatment effects and tolerability over time.

A Phase I Study of Hyper-CVAD In Combination With Venetoclax In Pediatric Patients With Relapsed or Refractory Acute Leukemias That Are of the Lymphoid Lineage Including Bi-Phenotypic or Undifferentiated Leukemias