Assessing Treatment of T-Cell Lymphoma With GW5282 in Combination With Golidocitinib (BEI-DOU3)

Официальное название

A Phase I/II Clinical Study to Evaluate the Efficacy and Safety of GW5282 in Combination With Golidocitinib in the Treatment of T-Cell Lymphoma

Обзор

This is a phase 1/2 open-label study to evaluate GW5282 in combination with golidocitinib (G2 regimen) for the treatment of T-cell lymphoma. In the first phase of the study, the maximum tolerated dose will be determined through dose escalation; in the second phase, the potential therapeutic advantages of the novel combination therapy over the conventional CHOP regimen will be preliminarily assessed through a randomized controlled design.

Вмешательства

• Препарат GW5282 combined with Golidocitinib
  GW5282 and Golidocitinib will be administered in combination as twice daily (BID) and once daily (QD), respectively. The starting dose will be GW5282 40 mg BID combined with golidocitinib 150 mg QD. If tolerated, the dose of GW5282 will be subsequently escalated.
• Препарат GW5282 combined with Golidocitinib
  GW5282 and Golidocitinib will be administered at the doses determined during escalation part.
• Препарат Conventional CHOP regimen
  CHOP regimen includes the administrations of Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone.

Первичные конечные точки

• Part A: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]). [Срок оценки: The DLT observation period is defined as the 21 days after the first dose.]
• Part B: Complete Response Rate (CRR) According to Lugano 2014 by Investigators' Review [Срок оценки: Up to 6 cycles, each cycle is 21 days]

Вторичные конечные точки (10)

• Part A: Plasma concentration of GW5282 and golidocitinib [Срок оценки: C1D1, C1D15, and Day 1 of Cycle 2~9]
• Part A: Efficacy parameters [Срок оценки: through the study completion, an average of around 1~2 years]
• Part A: Efficacy parameters [Срок оценки: through the study completion, an average of around 1~2 years]
• Part A: Efficacy parameters [Срок оценки: through the study completion, an average of around 1~2 years]
• Part A: Efficacy parameters [Срок оценки: through the study completion, an average of around 1~2 years]
• Part B: Other efficacy parameters [Срок оценки: through the study completion, an average of around 1~2 years]
• Part B: Other efficacy parameters [Срок оценки: through the study completion, an average of around 1~2 years]
• Part B: Other efficacy parameters [Срок оценки: through the study completion, an average of around 1~2 years]
• Part B: Adverse Events (AEs) / Serious Adverse Events (SAEs) [Срок оценки: through the study completion, an average of around 1~2 years]
• Part B: Plasma concentration of GW5282 and golidocitinib [Срок оценки: C1D1, C1D15, and Day 1 of subsequent cycles till treatment discontinuation]

Критерии участия

Критерии включения

• Signed informed consent;
• Adult ≥ 18 years of age;
• ECOG performance status score ≤ 2;
• Life expectancy of not less than 12 weeks;
• Histopathologically confirmed diagnosis of PTCL;
• Presence of measurable disease;
• Adequate bone marrow function and vital organ function reserve;
• Ability to comply with study requirements and to complete study-related procedures;
• Adequate contraception during participation in the trial.

Критерии исключения

• Presence of unresolved drug-related adverse events greater than Grade 1;
• Lymphoma involving the central nervous system;
• Failure to complete the required washout period for other anti-tumor therapies;
• Corticosteroid use that does not meet protocol requirements;
• Major surgery/trauma within a short period, or planned major surgery within a short period;
• Vaccination with a live vaccine within a short period;
• Inability to discontinue prohibited medications;
• Requirement for immunosuppressive agents or biologics due to an underlying disease;
• Presence of active infection;
• Significant cardiovascular disease;
• Presence of gastrointestinal disease that might affect drug intake or absorption;
• History of other malignancies;
• Known allergy to the study drug;
• Other severe or uncontrolled systemic diseases;
• Personnel with a conflict of interest (e.g., site staff, sponsor employees);
• Pregnant or breastfeeding women;
• Inability to comply with protocol requirements.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 12 центров

• Chongqing Cancer Hospital — Чунцин
• Fujian Cancer Hospital — Фучжоу
• Guangxi Medical University Cancer Hospital — Nanning
• Henan Provincial People's Hospital — Чжэнчжоу
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Ухань
• Nanjing Drum Tower Hospital — Нанкин
• West China Hospital of Sichuan University — Чэнду
• Taizhou Hospital of Zhejiang Province — Taizhou
• … и ещё 4 центра

Идентификаторы

NCT: NCT07496229 · GW2025EZ0002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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