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ACTIVE NOT RECRUITING
NCT07541755
PHASE3

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

Sponsor: Fujian Medical University Union Hospital

View on ClinicalTrials.gov

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

Interventions

DRUG

PD-1 Inhibitors

PD-1 inhibitor+venetoclax+Cytarabine+Aclarubicin+G-CSF regimen

Locations (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, China