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

Study acronym: PD1-VEN-CAG
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07541755
Lead Sponsor Fujian Medical University Union Hospital
Conditions
(from sponsor)		 Acute T Lymphoblastic Leukemia (T-ALL)
Related terms Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov