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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат TR115
  TR115 will be administered orally twice daily until documented disease progression, unacceptable toxicity, withdrawal of consent, death, or study discontinuation.
• Препарат Investigator's Choice
  Investigator's choice treatment with chidamide, golidocitinib, mitoxantrone hydrochloride liposome, or gemcitabine hydrochloride administered according to the respective approved prescribing information.

Первичные конечные точки

• Progression-Free Survival (PFS) [Срок оценки: From randomization to disease progression or death from any cause, whichever occurs first, assessed up to 36 months.]

Вторичные конечные точки (7)

• Overall Survival (OS) [Срок оценки: From randomization to death from any cause, assessed up to 36 months.]
• Objective Response Rate (ORR) [Срок оценки: Up to 36 months]
• Disease Control Rate (DCR) [Срок оценки: Up to 36 months]
• Duration of Response (DOR) [Срок оценки: From first documented response to disease progression or death, assessed up to 36 months.]
• Time to Response (TTR) [Срок оценки: From randomization to first documented response, assessed up to 36 months.]
• Safety and Tolerability [Срок оценки: 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 [Срок оценки: 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.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking University Cancer Hospital — Beijin

Идентификаторы

NCT: NCT07639879 · TR115-CN-PIII-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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