Health Trials

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

ConditionsPTCLNK T-Cell Lymphoma
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorTarapeutics Science Inc.

About this trial

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 criteria

Qualifiers

Histologically confirmed peripheral T-cell lymphoma (PTCL), including PTCL-NOS, AITL, ALCL, or NKTCL

Received at least one prior systemic therapy and prior exposure to at least one novel agent (e.g., chidamide, pralatrexate, brentuximab vedotin, etc.) or refractory/intolerant to such therapies

Age ≥18 years

ECOG performance status 0-1

Disqualifiers

Prior treatment with EZH2 or EZH1/2 inhibitors resulting in disease progression (intolerance permitted)

Known central nervous system involvement of lymphoma

Active uncontrolled infection requiring systemic therapy

Significant or uncontrolled cardiovascular disease

Trial design

Treatments tested in this trial

  • TR115
  • Investigator's Choice

Treatment groups

180 Participants
are divided into 2 treatment groups

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Peking University Cancer Hospital Status unavailable 100142, Beijin, Beijing MunicipalityChinaChina

Sponsors and collaborators

Tarapeutics Science Inc.

Lead sponsor

Source ClinicalTrials.gov