A Global Phase 3 Study of Orelabrutinib+BR Vs.BR in Pts with TN MCL

Официальное название

A Randomized, Double-Blind, Multicenter, Placebo-Controlled Phase 3 Study of Orelabrutinib in Combination with Rituximab and Bendamustine (BR) Vs. BR in Subjects with Treatment-Naїve Mantle Cell Lymphoma

Обзор

Compare the efficacy and safety of Orelabrutinib plus bendamustine+ rituximab versus bendamustine + rituximab in previously untreated patients with mantle cell lymphoma (MCL)

Вмешательства

• Препарат Orelabrutinib
  Eligible patients will receive Orelabrutinib orally as per the protocol，until disease progression or other reasons for treatment discontinuation，whichever comes first.
• Препарат Bendamustine Injection
  Eligible patients will receive Bendamustine by injection as per the protocol
• Препарат Rituximab
  Eligible patients will receive Rituximab by injection as per the protocol
• Препарат Orelabrutinib Placebo
  Eligible patients will receive Orelabrutinib Placebo orally as per the protocol

Первичные конечные точки

• Dose-limiting toxicity (DLT) [Срок оценки: 28 days]
• Progression-free Survival (PFS) for Arm A vs. Arm B [Срок оценки: Approximately 7 years]

Критерии участия

Критерии включения

• Subjects ≥ 65 of age, or ≥ 60 and < 65 years old who are ineligible for stem cell transplant or have refused stem cell transplantation due to reason(s) including: Have not received prior systemic therapies for MCL.
• Modified Ann Arbor stage II-IV. Patients with stage II require systemic treatment to be eligible, at the discretion of the investigator.
• Histopathological confirmed MCL, expression of Cyclin D1 and/or t (11; 14) chromosomal translocation. Either fresh tissue or FFPE for diagnosis must be sent to central lab for final confirmation after randomization.
• At least one measurable site of disease (the longest axis of the lymph node lesion is > 1.5 cm, or the longest diameter of the extranodal lesion is > 1.0 cm).
• ECOG PS score of 0 to 2.

Критерии исключения

• Existing or prior history of other malignant tumor and no evidence of recurrence and metastasis within 2 years before screening.
• Subjects with evident gastrointestinal dysfunction that may affect drug intake, transport or absorption, or subjects who have undergone total gastrectomy.
• Subjects for whom the goal of therapy is tumor debulking prior to stem cell transplant.
• Use of strong inhibitors or strong inducers of cytochrome P450 3A within 14 days or 5 half-lives, whichever is longer, before the first dose of study treatment; or plan to use strong inhibitors or strong inducers of CYP3A during the study.
• Known central nervous system lymphoma.

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

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 39 центров

• Beijing Cancer Hospital — Пекин
• Peking University Third Hospital — Пекин
• The First Affiliated Hospital of Bengbu Medical University — Bengbu
• First Hospital of Jilin University — Changchun
• Hunan Cancer Hospital — Чанша
• The First People's Hospital of Changzhou — Changzhou
• Sichuan Provincial People's Hospital — Чэнду
• West China Hospital of Sichuan University — Чэнду
• … и ещё 31 центр

Идентификаторы

NCT: NCT06363994 · ICP-CL-00128

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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