drugset / Trial / NCT06037239

Phase I/II Study of Linperlisib Plus Chidamide for R/R Cutaneous T-cell Lymphoma: a Prospective, Single-center Study

NCT06037239

Phase 1/2 Unknown 53 enrolled Peking Union Medical College Hospital
NaSingle-groupOpen-labelTreatment

Summary

HDAC inhibitor chidamide and PI3K inhibitor linperlisib has shown clinical activity as mono therapy in PTCL. The combination of duvelisib and romidepsin is highly active against relapsed and refractory T-cell lymphomas including cutaneous T-cell lymphomas (CTCLs). The aim of this study is to further explore the efficacy and safety of HDAC inhibitor chidamide combined with PI3K inhibitor linperlisib in the treatment of relapsed and refractory CTCLs.

Timeline

Start
2023-07-01
Primary completion
2024-07
Completion
2025-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Linperlisib Small molecule 40 mg Oral
Subject Linperlisib Small molecule 60 mg Oral
Subject Linperlisib Small molecule 80 mg Oral
Subject Tucidinostat Small molecule 20 mg Oral

Indications