drugset / Trial / NCT06536959

VA Combined With PD-1 Inhibitor for the Treatment of Relapsed and Refractory AML and High-risk MDS

NCT06536959 ↗

Phase 2 Recruiting 67 enrolled Beijing 302 Hospital
NaSingle-groupOpen-labelTreatment

Summary

The efficiency and safety of PD-1 inhibitor in combination with venetoclax and hypomethylation agent in relapsed/refractory acute myeloid leukemia or high-risk myelodysplastic syndrome remain uncertain. In this study, the investigators aimed to assess safety and response to a new PD-1 inhibitor-based triple-drug combination regimen (venetoclax + hypomethylation agent + PD-1 inhibitor) in relapsed/refractory acute myeloid leukemia and high-risk myelodysplastic syndrome patients, or who had positive minimal residual disease.

Timeline

Start
2024-07-18
Primary completion
2026-07-31
Completion
2027-07-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Azacitidine Other / unclassified 75 mg/m2 —
Subject Decitabine Small molecule 20 mg/m2 —
Subject Tislelizumab Monoclonal antibody 200 mg —
Subject Venetoclax Small molecule 400 mg —