A Phase 3 Multinational Study of Golidocitinib Versus Investigator's Choice in r/r PTCL (JACKPOT19)

Официальное название

A Phase 3, Open-Label, Randomized, Multinational Study to Investigate the Anti-tumor Efficacy of Golidocitinib Versus Investigator's Choice in Adult Patients With Relapsed/Refractory Peripheral T-cell Lymphoma

Обзор

This is a phase 3, open-label, randomized, multinational study to evaluate the anti-tumor efficacy of golidocitinib versus investigator's choice in adult patients with relapsed/refractory peripheral T-cell lymphoma (r/r PTCL). This study will treat patients with pathologically confirmed PTCL who have relapsed after or been refractory/intolerant to at least one prior systemic treatment regimen(s).

Вмешательства

• Препарат Golidocitinib
  150 mg, orally, once daily, with or without food, in a 21-day cycle
• Препарат Chidamide
  30 mg, orally, twice a week, with an interval of no less than 3 days in a 21-day cycle
• Препарат Gemcitabine
  1000 mg/m2, intravenous infusion, administered on Day 1, Day 8 and Day 15 of a 28-day cycle

Первичные конечные точки

• Progression-free survival (PFS) assessed by the Independent Review Committee (IRC) according to Lugano 2014 [Срок оценки: The time from the date of randomization to the date of first progressive disease, death due to any cause whichever occurred first. Approximately 4 years.]

Вторичные конечные точки (1)

• Overall survival (OS) [Срок оценки: The time from randomization to death due to any cause. Approximately 4 years.]

Критерии участия

Критерии включения

• The participants should sign the ICF and be able to comply with the relevant requirements in the ICF and protocol
• Age ≥ 18 years
• ECOG 0-2 score, life expectancy ≥ 12 weeks
• Patients must have histologically confirmed peripheral T-cell lymphoma according to the World Health Organization classification of lymphoma. Eligible subtypes are restricted to: PTCL-not otherwise specified, NOS (PTCL, NOS), Angioimmunoblastic T-cell lymphoma (AITL), anaplastic large-cell lymphoma ALK-positive (ALCL ALK+), anaplastic large-cell lymphoma ALK-negative (ALCL ALK-), Follicular T-cell lymphoma, or PTCL with T-follicular helper (TFH) phenotype (FTCL or PTCL-TFH), Enteropathy-associated T-cell lymphoma (EATL), Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL), Natural killer/T-cell lymphoma (NK/TCL), Hepatosplenic T-cell lymphoma (HSTCL), Subcutaneous panniculitis-like T-cell lymphoma (SPTCL)
• Progressed on, were refractory to or intolerant to at least one line of prior standard systemic therapies assessed by investigator
• Adequate bone marrow reserve and organ system functions
• Willing to comply with contraceptive restrictions

Критерии исключения

• Any of previous or current treatment prohibited by protocol
• Any unresolved > grade 2 drug-related adverse events
• Lymphoma involving central nervous system
• Any of severe cardiac or pulmonary abnormalities
• Disease condition requires immunosuppressants, biologics, or NSAIDs
• Active infection
• Malignancy disease within five years
• Poorly controlled gastrointestinal disorder or inadequate absorption of medication
• Severe or poorly controlled systemic diseases

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 · 36 центров

• Anhui Provincial Cancer Hospital — Хэфэй
• The Second Hospital of Anhui Medical University — Хэфэй
• Beijing Hospital — Пекин
• Beijing Tongren Hospital, CMU — Пекин
• Peking University Third Hospital — Пекин
• The First Affiliated Hospital of Chongqing Medical University — Чунцин
• Fujian Cancer Hospital — Фучжоу
• The First Affiliated Hospital of Xiamen University — Xiamen
• … и ещё 28 центров

Тайвань · 8 центров

• Chang Bing Show Chwan Memorial Hospital — Changhua
• Kaohsiung Chang Gung Memorial Hospital — Kaohsiung City
• Taipei Medical University - Shuang Ho Hospital — New Taipei City
• China Medical University Hospital — Taichung
• Chi Mei Medical Center - Liouying Branch — Tainan
• National Cheng Kung University Hospital — Tainan
• National Taiwan University Hospital — Taipei
• Koo Foundation Sun Yat-Sen Cancer Center — Taipei

Таиланд · 7 центров

• King Chulalongkorn Memorial Hospital — Bangkok
• Mahidol University - Faculty of Medicine - Ramathibodi Hospital — Bangkok
• Phramongkutklao Hospital — Bangkok
• Siriraj Hospital - Mahidol University — Bangkok
• Maharaj Nakorn Chiang Mai Hospital — Chiang Mai
• Prince of Songkla University-Faculty of Medicine — Hat Yai
• Srinagarind Hospital - Faculty of Medicine Khon Kaen University — Khon Kaen

Идентификаторы

NCT: NCT07234162 · DZ2022J0004

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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