drugset / Trial / NCT07541755

PD-1 Inhibitors +Venetoclax+CAG Regimens in R/R T-ALL

NCT07541755

Phase 3 Active not recruiting 40 enrolled Fujian Medical University Union Hospital
NaSingle-groupOpen-labelTreatment

Summary

This prospective multicenter study evaluates the efficacy and safety of PD-1 inhibitor combined with venetoclax and HAG/CAG chemotherapy in refractory/relapsed T-ALL (R/R T-ALL). Despite standard chemotherapy, R/R T-ALL remains challenging, with low salvage remission rates (\~40%) and poor survival. Preclinical data suggest PD-1 blockade enhances leukemic stem cell eradication, while venetoclax (BCL-2 inhibitor) synergizes with chemotherapy. Eligible patients receive 1-2 cycles of PD-1 inhibitor + venetoclax + CAG, with responders proceeding to allo-HSCT or MRD-guided consolidation. The trial aims to improve CR rates and survival, offering a novel immunochemotherapy approach for this high-risk population.

Timeline

Start
2025-05-01
Primary completion
2027-01-31
Completion
2029-01-31

Drugs

EvaluationDrugModalityDoseRoute
Background Aclarubicin Small molecule
Background Cytarabine Small molecule
Background Venetoclax Small molecule Oral