Phase 2 Study of Calaspargase Pegol-mknl, Decitabine, and Venetoclax for Children and Young Adults with Relapsed or Resistant T-cell Acute Lymphoblastic Leukemia and T-Cell Lymphoblastic Lymphoma

What this Trial Is About

Researchers are studying pediatric, adolescent, and young adult patients with relapsed or refractory T-cell Acute Lymphoblastic Leukemia T-ALL and T-Cell Lymphoblastic Lymphoma T-LLy. This Phase 2 trial aims to evaluate the effects of combining the study drugs calaspargase pegol-mknl, decitabine, and venetoclax on these conditions. The study also focuses on the safety of this drug combination and its ability to help patients proceed to hematopoietic stem cell transplant HSCT. Participants receive calaspargase pegol-mknl and decitabine intravenously, while venetoclax is taken by mouth. The study assesses how well this combination works by measuring complete response rates, overall survival, event-free survival, and the rate of minimal residual disease negativity. Researchers also study the pharmacokinetics of calaspargase pegol-mknl and its relationship with asparagine levels, as well as the impact of certain antibodies on treatment outcomes. During the study, participants undergo regular evaluations including clinical assessments, laboratory tests, and monitoring for adverse events according to standardized criteria. The research team tracks safety through adverse event reporting throughout the study, which lasts up to approximately one year. They will also observe patient outcomes related to treatment response and ability to proceed to HSCT, with follow-up continuing through study completion.

A Phase 2 Study to Evaluate Efficacy of Calaspargase Pegol-mknl and Decitabine Combined With Venetoclax in Pediatric, Adolescent, and Young Adult Patients With Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL) and T- Cell Lymphoblastic Lymphoma (T-LLy)