Идёт набор NCT06742996

A Study to Investigate the Efficacy and Safety of Sonrotoclax Plus Zanubrutinib Compared With Placebo Plus Zanubrutinib in Adults With Relapsed/Refractory Mantle Cell Lymphoma (CELESTIAL-RRMCL)

Фаза III С лечением Mantle Cell Lymphoma B Cell Lymphoma

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Sonrotoclax, Zanubrutinib, Placebo.
Кому может быть актуально: Состояния в реестре: Mantle Cell Lymphoma, B Cell Lymphoma. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Аргентина, Австралия, Австрия, Бразилия +12
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Phase 3 Randomized Double-Blind Multicenter Study of Sonrotoclax Plus Zanubrutinib Versus Placebo Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma

Обзор

The goal of this study is to compare how well sonrotoclax plus zanubrutinib works versus zanubrutinib plus placebo in treating adults with relapsed/refractory (R/R) mantle cell lymphoma (MCL). This study will also look at the safety of sonrotoclax plus zanubrutinib versus zanubrutinib plus placebo.

Подробное описание

Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.

Вмешательства

Препарат Sonrotoclax
Administered orally
Препарат Zanubrutinib
Administered orally
Препарат Placebo
Administered orally

Первичные конечные точки

Progression-Free Survival (PFS) as assessed by Blinded Independent Review Committee (BIRC) [Срок оценки: Approximately 41 months]

Вторичные конечные точки (10)

Overall Survival (OS) [Срок оценки: Approximately 92 months]
PFS as assessed by investigator (INV) [Срок оценки: Approximately 58 months]
Overall Response Rate (ORR) as assessed by BIRC and by INV [Срок оценки: Approximately 58 months]
Duration of Response (DOR) as assessed by BIRC and by INV [Срок оценки: Approximately 58 months]
Complete Response Rate (CRR) as assessed by BIRC and by INV [Срок оценки: Approximately 58 months]
Time to first response as assessed by BIRC and by INV [Срок оценки: Approximately 58 months]
Time to initiation of new anticancer therapy [Срок оценки: Approximately 58 months]
Health-Related Quality of Life (HRQoL) as Assessed by the European Organisation of Research and Treatment of Cancer-Quality of Life Questionnaire Non-Hodgkin Lymphoma High Grade Module 29 (EORTC-QLQ-NHL-HG29) [Срок оценки: Approximately 58 months]
Health-Related Quality of Life (HRQoL) as Assessed by the European Organisation of Research and Treatment of Cancer-Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) [Срок оценки: Approximately 58 months]
Number of participants with treatment-emergent adverse events (TEAEs) [Срок оценки: From the first dose of study drug(s) to 30 days after the last dose; up to approximately 58 months]

Критерии участия

Критерии включения

Histologically locally confirmed diagnosis of MCL based on the World Health Organization 2022 classification of Haematolymphoid Tumors (WHO-HAEM5), or based on International Consensus Classification (ICC)
Ability to provide archival or fresh tumor tissue for retrospective central confirmation of MCL diagnosis
Received 1 to 5 prior lines of systemic therapy including an anti-CD20 monoclonal antibody (mAb)-based immunotherapy or chemoimmunotherapy and requiring treatment in the opinion of the investigator
Relapsed or refractory disease after the last line of therapy
Measurable disease defined as ≥ 1 nodal lesion that is > 1.5 cm in longest diameter, or ≥ 1 extranodal lesion that is > 1 cm in longest diameter
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
Adequate organ function

Критерии исключения

Prior therapy with B-cell lymphoma-2 inhibitor (BCL2i)
Prior therapy with BTK degraders
Prior therapy with covalent or non-covalent Bruton tyrosine kinase inhibitor (BTKi) unless the participant was intolerant of non-zanubrutinib covalent or non-covalent BTKi. Participants with refractory disease to BTKi therapy or relapse attributed to failure of BTKi therapy are ineligible.
Prior autologous stem cell transplantation or chimeric antigen receptor T-cell therapy within 3 months before first dose of study drug
Prior allogeneic stem cell transplant within 6 months of the first dose of the study drug
Known central nervous system involvement by lymphoma
Clinically significant cardiovascular disease
History of stroke or intracranial hemorrhage within 6 months before first dose of study drug

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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: Двойное слепое
Основная цель: Лечение

Центры проведения

США · 41 центр

University of Alabama At Birmingham Hospital — Birmingham
University of Arizona Cancer Center — Tucson
Ucsf Fresno — Fresno
Kaiser Permanente Southern California — Irvine
Yale University Yale Cancer Center — New Haven
Memorial Cancer Institute, Memorial Healthcare System — Pembroke Pines
Cleveland Clinic Florida — Weston
Rush University Medical Center — Chicago
… и ещё 33 центра

Китай · 20 центров

Beijing Cancer Hospital — Пекин
Beijing Hospital — Пекин
The First Affiliated Hospital of Chongqing Medical University — Чунцин
Sun Yat Sen University Cancer Center — Гуанчжоу
Nanfang Hospital, Southern Medical University — Гуанчжоу
Harbin Medical University Cancer Hospital — Харбин
The First Affiliated Hospital of Zhengzhou University — Чжэнчжоу
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology — Ухань
… и ещё 12 центров

Япония · 18 центров