Clinical trial · Interventional
TR115 VS Investigator's Choice in Relapsed/Refractory Peripheral T/NK Cell Lymphoma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NK T-Cell Lymphoma | Nasal Type Extranodal NK/T-Cell Lymphoma | PROBABILISTIC | 0.70 |
| PTCL | Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Investigator's Choice | Drug | — | UNRESOLVED |
| TR115 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TR115 tablet
- interventionNames
- Drug: TR115
- type
- ACTIVE_COMPARATOR
- label
- Investigator's Choice
- interventionNames
- Drug: Investigator's Choice
Primary outcomes (1)
- measure
- Progression-Free Survival (PFS)
- timeFrame
- From randomization to disease progression or death from any cause, whichever occurs first, assessed up to 36 months.
- description
- Assessed by Independent Review Committee (IRC) per Lugano 2014 criteria
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * At least one measurable lesion per Lugano 2014 criteria (lymph node ≥1.5 cm in longest diameter or extranodal lesion ≥1.0 cm) * Adequate organ function, defined as: ANC ≥1.5 × 10⁹/L, Platelets ≥100 × 10⁹/L, Hemoglobin ≥100 g/L, Total bilirubin ≤1.5 × ULN, ALT/AST ≤2.5 × ULN (≤5 × ULN if liver involvement), Creatinine clearance ≥50 mL/min (Cockcroft-Gault), LVEF ≥50%, QTcF \<450 ms (male), \<470 ms (female) * Willingness to provide archival or fresh tumor tissue * Life expectancy ≥3 months Exclusion Criteria: * 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 * Prior allogeneic stem cell transplantation or autologous stem cell transplantation within 90 days prior to first dose * Pregnancy or lactation, or unwillingness to use effective contraception * Other malignancies within 5 years, except adequately treated basal cell carcinoma, squamous cell carcinoma, carcinoma in situ, or thyroid carcinoma * Patients planned to receive mitoxantrone liposomal therapy with prior cumulative doxorubicin exposure ≥350 mg/m² (or equivalent anthracycline exposure)
References
Publications (0)
Data not yet available