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PD-1 Inhibitors +Venetoclax+CAG Regimens in R/R T-ALL
Sponsor: Fujian Medical University Union Hospital
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.
Official title: A Prospective, Multicenter Clinical Study on the Efficacy and Safety of PD-1 Inhibitors Combined With Venetoclax+CAG Regimens in the Treatment of Adult Refractory/Relapsed Acute T-lymphoblastic Leukemia (T-ALL)
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2025-05-01
Completion Date
2029-01-31
Last Updated
2026-04-21
Healthy Volunteers
No
Conditions
Interventions
PD-1 Inhibitors
PD-1 inhibitor+venetoclax+Cytarabine+Aclarubicin+G-CSF regimen
Locations (1)
Fujian Medical University Union Hospital
Fuzhou, Fujian, China