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 for relapsed and refractory PTCLs. 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 PTCLs.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
* Phase 1: dose escalation phase. Drug Linperlisib: 3 dose level of 40mg, 60mg, 80mg qd; Drug Chidamide: fixed dose of 20mg twice weekly in a 4-week cycle; * Phase 2: dose expansion phase. Drug Linperlisib: RP2D established in the phase I study; Drug Chidamide: fixed dose of 20mg twice weekly in a 4-week cycle;
Peking Union Medical College Hospital
Beijing, Beijing/China, China
RECRUITINGBeijing Hospital
Beijing, China
RECRUITINGRecommended phase 2 dose (RP2D)
Recommended phase 2 dose (RP2D) and/or maximum tolerated dose (MTD) will be established according to the incidence of dose-limiting toxicities (DLTs) of escalated doses of linperlisib.
Time frame: 4 weeks since the date of first dose
Objective response rate (ORR)
Objective response rate (ORR) for phase 2 study
Time frame: evaluated every 3 months (up to 24 months)
Progression-free survival
Progression-free survival was defined as the time from the date of enrollment until the date of the first documented day of disease progression or relapse, or death from any cause, whichever occurred first.
Time frame: recruitment to data cut-off (up to 5 years)
Overall survival
Overall survival was defined as the time from the date of enrollment to the date of death from any cause.
Time frame: recruitment to data cut-off (up to 5 years)
complete remission (CR) rate
Treatment responses were assessed according to the 2014 Lugano classification criteria
Time frame: evaluated every 3 months (up to 24 months)
adverse events
Graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time frame: evaluated every treatment cycle (up to 24 months)
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