Phase 3 PD-1 + Venetoclax + CAG for Relapsed/Refractory T-ALL
Summary
This ClinicalTrials.gov registry entry documents Phase 3 trial NCT07541755, a prospective multicenter study evaluating PD-1 inhibitor combined with venetoclax (BCL-2 inhibitor) and HAG/CAG chemotherapy for patients with refractory/relapsed T-cell acute lymphoblastic leukemia (R/R T-ALL). The trial enrolled patients who received 1-2 cycles of the triple combination, with responders proceeding to allogeneic hematopoietic stem cell transplantation or MRD-guided consolidation. The study aims to improve complete remission rates and survival in a high-risk population with historically low salvage remission rates.
What changed
This ClinicalTrials.gov registry entry records a new Phase 3 clinical trial (NCT07541755) investigating the combination of PD-1 inhibitors, venetoclax, and CAG/HAG chemotherapy regimens in adult patients with relapsed or refractory T-cell acute lymphoblastic leukemia. The trial follows preclinical evidence suggesting PD-1 blockade may enhance leukemic stem cell eradication while venetoclax synergizes with chemotherapy.
For sponsors and clinical investigators in oncology, this registry entry signals active clinical development of immunochemotherapy approaches for high-risk hematologic malignancies. Sites with relevant patient populations may consider trial participation or internal feasibility assessment.
Archived snapshot
Apr 21, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
PD-1 Inhibitors +Venetoclax+CAG Regimens in R/R T-ALL
Phase 3 NCT07541755 Kind: PHASE3 Apr 21, 2026
Abstract
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.
Conditions: Acute T Lymphoblastic Leukemia (T-ALL)
Interventions: PD-1 Inhibitors
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