TR115 VS Investigator's Choice in Relapsed/Refractory Peripheral T/NK Cell Lymphoma
Condition(s) studied
Investigational drug(s) / intervention(s)
TR115: TR115 will be administered orally twice daily until documented disease progression, unacceptable toxicity, withdrawal of consent, death, or study discontinuation.
Investigator's Choice: Investigator's choice treatment with chidamide, golidocitinib, mitoxantrone hydrochloride liposome, or gemcitabine hydrochloride administered according to the respective approved prescribing information.
Study summary
This is a randomized, open-label, multicenter Phase III study evaluating the efficacy and safety of TR115, an EZH2 inhibitor, versus investigator's choice (chidamide, golidocitinib, mitoxantrone liposome, or gemcitabine) in patients with relapsed and/or refractory peripheral T/NK-cell lymphoma. Approximately 180 patients will be randomized in a 1:1 ratio. The primary endpoint is progression-free survival (PFS) assessed by an Independent Review Committee (IRC). The key secondary endpoint is overall survival (OS). The study is being conducted at approximately 40 to 60 centers across China.
Eligibility
Primary outcome measure(s)
- Progression-Free Survival (PFS) — From randomization to disease progression or death from any cause, whichever occurs first, assessed up to 36 months.
Assessed by Independent Review Committee (IRC) per Lugano 2014 criteria
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Peking University Cancer Hospital | Beijin | Beijing Municipality |
More Tarapeutics Science Inc. trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07639879 on ClinicalTrials.gov ↗ ← All trials in China