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NOT YET RECRUITING
NCT07639879
PHASE3

TR115 VS Investigator's Choice in Relapsed/Refractory Peripheral T/NK Cell Lymphoma

Sponsor: Tarapeutics Science Inc.

View on ClinicalTrials.gov

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.

Official title: A Randomized, Controlled, Open-label, Multicenter Phase III Trial to Evaluate the Efficacy and Safety of TR115 in Patients With Relapsed and/or Refractory Peripheral T/NK-Cell Lymphoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2026-07-30

Completion Date

2030-07-30

Last Updated

2026-06-10

Healthy Volunteers

No

Interventions

DRUG

TR115

TR115 will be administered orally twice daily until documented disease progression, unacceptable toxicity, withdrawal of consent, death, or study discontinuation.

DRUG

Investigator's Choice

Investigator's choice treatment with chidamide, golidocitinib, mitoxantrone hydrochloride liposome, or gemcitabine hydrochloride administered according to the respective approved prescribing information.

Locations (1)

Peking University Cancer Hospital

Beijin, Beijing Municipality, China