TR115 VS Investigator's Choice in Relapsed/Refractory Peripheral T/NK Cell Lymphoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TR115, Investigator's Choice.
- Who it may be relevant to
- Registry conditions: PTCL, NK T-Cell Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
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.
Primary outcome measures
- Progression-Free Survival (PFS) [Time frame: From randomization to disease progression or death from any cause, whichever occurs first, assessed up to 36 months.]
Secondary outcome measures (7)
- Overall Survival (OS) [Time frame: From randomization to death from any cause, assessed up to 36 months.]
- Objective Response Rate (ORR) [Time frame: Up to 36 months]
- Disease Control Rate (DCR) [Time frame: Up to 36 months]
- Duration of Response (DOR) [Time frame: From first documented response to disease progression or death, assessed up to 36 months.]
- Time to Response (TTR) [Time frame: From randomization to first documented response, assessed up to 36 months.]
- Safety and Tolerability [Time frame: From first dose of study treatment until 30 days after the last dose, or until initiation of new anti-cancer therapy, whichever occurs first, up to approximately 36 months.]
- Population Pharmacokinetics of TR115 [Time frame: Pre-dose and approximately 2 hours (±6 minutes) post-dose on Cycle 1 Day 1, Cycle 2 Day 1, and Cycle 3 Day 1, up to approximately 36 months.]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking University Cancer Hospital — Beijin
Identifiers
NCT: NCT07639879 · TR115-CN-PIII-01