A Phase 1/2 interventional study of Linperlisib in combined with Chidamide in Peripheral T Cell Lymphoma, sponsored by Peking Union Medical College Hospital. Recruiting at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-10-16.
Sponsored by Peking Union Medical College Hospital · Phase 1/2, Interventional, and Treatment
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's planned enrollment of 32 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adequate bone marrow hematopoietic function: neutrophil count (ANC)
≥1.5×109/L, platelet count (PLT) ≥80×109/L, hemoglobin (HGB) ≥90g/L;
Exclusion Criteria:
Linperlisib combined with chidamide
Drug: Linperlisib in combined with Chidamide
* 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;
Recommended 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)
Plan to share: Undecided
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Peking Union Medical College Hospital