A Study of BGB-16673 Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both Bruton Tyrosine Kinase (BTK) and B-cell Leukemia/Lymphoma 2 Protein (BCL2) Inhibitors
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: BGB-16673, Bendamustine, Idelalisib, Rituximab.
- Кому может быть актуально
- Состояния в реестре: CLL, Chronic Lymphocytic Leukemia. 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, Бразилия, Канада +9
- 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, Open-Label, Randomized Study of BGB-16673 Compared to Investigator's Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab or Venetoclax Plus Rituximab Retreatment) in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both BTK and BCL2 Inhibitors
Обзор
The purpose of this study is to investigate the efficacy and safety of BGB-16673 compared with investigator's choice (idelalisib plus rituximab \[for CLL only\] or bendamustine plus rituximab or venetoclax plus rituximab retreatment) in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) previously exposed to both BTK inhibitors (BTKi) and BCL2 inhibitors (BCL2i).
Подробное описание
Chronic lymphocytic leukemia is a type of blood cancer that affects people around the world. People with CLL suffer from enlarged lymph nodes, spleen, or liver, or have symptoms like night sweats, weight loss and fever. They have shorter life expectancy compared to healthy people. There is an urgent need for new treatment to prolong life and control disease-related symptoms.
In this study, participants with relapsed/refractory (R/R) CLL who were previously exposed to a BTKi and a BCL2i will receive BGB-16673 or the investigator's choice of idelalisib plus rituximab (for CLL only) or bendamustine plus rituximab or venetoclax plus rituximab retreatment. The main purpose of this study is to compare the length of time that participants live without their CLL or SLL worsening between those participants who receive BGB-16673 versus the investigator's choice of treatment (idelalisib plus rituximab or bendamustine plus rituximab, or venetoclax plus rituximab).
Approximately 250 participants will be included in this study around the world. Participants will be randomly allocated to receive either BGB-16673 or the investigator's choice of treatment.
"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 BGB-16673
Administered orally - Препарат Bendamustine
Administered intravenously - Препарат Idelalisib
Administered orally - Препарат Rituximab
Administered intravenously - Препарат Venetoclax
Administered orally
Первичные конечные точки
- Progression-Free Survival (PFS) by Independent Review Committee (IRC) [Срок оценки: Approximately 36 Months]
Вторичные конечные точки (10)
- Overall Survival (OS) [Срок оценки: Approximately 36 Months]
- Progression-Free Survival (PFS) in Participants with Prior Exposure to Noncovalent Bruton Tyrosine Kinase Inhibitor(s) (ncBTKi) by IRC [Срок оценки: Approximately 36 Months]
- PFS by the Investigator Assessment [Срок оценки: Approximately 36 Months]
- Overall Response Rate (ORR) by IRC and Investigator Assessment [Срок оценки: Approximately 36 Months]
- Rate of Partial Response with Lymphocytosis (PR-L) or Higher Determined by IRC and by Investigator Assessment [Срок оценки: Approximately 36 Months]
- Duration of Response (DOR) by IRC and Investigator Assessment [Срок оценки: Approximately 36 Months]
- Time to Next Anti-CLL/SLL Treatment (TTNT) [Срок оценки: Approximately 36 Months]
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) [Срок оценки: Approximately 36 Months]
- Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Questionnaire -Core 30 (EORTC QLQ-C30) Global Health Status/QoL (GHS) and Physical Functioning Scales [Срок оценки: Approximately 24 Months]
- Change from baseline in EORTC Quality of Life Questionnaire - Chronic Lymphocytic Leukemia Module 17 Items (QLQ-CLL17) Symptom Burden and Physical Condition Scales [Срок оценки: Approximately 24 Months]
Критерии участия
Критерии включения
- Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria.
- Previously received treatment for CLL/SLL with both a BTKi and a BCL2i.
- Participants with SLL must have measurable disease by computer tomography (CT)/magnetic resonance imaging (MRI)
- Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2
- Adequate liver function
- Adequate blood clotting function
Критерии исключения
- Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
- Prior autologous stem cell transplant or chimeric antigen receptor-T cell therapy in the last 3 months
- Known central nervous system involvement
- Prior exposure to any BTK protein degraders
- Active fungal, bacterial and/or viral infection requiring parenteral systemic therapy
- Clinically significant cardiovascular disease
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
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 25 центров
- St Bernards Medical Center — Jonesboro
- UCLA Department of Medicine Hematologyoncology — Los Angeles
- Pih Health Whittier Hospital — Whittier
- Rocky Mountain Cancer Centers (Williams) Usor — Aurora
- Florida Oncology and Hematology — Fort Myers
- Baptist Md Anderson Cancer Center — Jacksonville
- Cleveland Clinic Florida — Weston
- Emory University Winship Cancer Institute — Atlanta
- … и ещё 17 центров
Япония · 18 центров
Список центров уточняется — проверьте первичный протокол.
Бразилия · 15 центров
- CETUS — Belo Horizonte
- Hospital Sirio Libanes Brasilia — Brasília
- Hospital Erasto Gaertner — Curitiba
- Centro de Ensino E Pesquisa Em Oncologia de Santa Catarina (Cepen) — Florianópolis
- Instituto Joinvilense de Hematologia E Oncologia — Joinville
- Complexo Hospitalar de Niteroi — Niterói
- Centro Gaucho Integrado de Oncologia Hospital Mae de Deus — Porto Alegre
- Hospital Santa Joana Recife — Recife
- … и ещё 7 центров
Германия · 12 центров
- Universitatsklinikum Augsburg — Augsburg
- Praxis Am Volkspark — Berlin
- Klinikum Chemnitz Ggmbh — Chemnitz
- Universitatsklinikum Essen (Aor) — Essen
- Centrum Fur Haematologie Und Onkologie Bethanien — Frankfurt am Main
- Universitatsklinikum Freiburg I Br Klinik Fur Innere Medizin I — Freiburg im Breisgau
- Universitatsklinikum Hamburg Eppendorf — Hamburg
- Universitatsklinikum Heidelberg — Heidelberg
- … и ещё 4 центра
Италия · 9 центров
- Irccs Istituto Tumori Giovanni Paolo Ii — Bari
- Aou Careggi, Servizio Sanitario Toscana — Florence
- Fondazione Irccs Ca Granda Ospedale Maggiore Policlinico — Milan
- Ospedale San Raffaele — Milan
- Azienda Ospedaliera Universitaria Federico Ii — Naples
- … и ещё 4 центра
Австралия · 8 центров
- Concord Repatriation General Hospital — Concord
- Gosford Hospital — Gosford
- Port Macquarie Base Hospital — Port Macquarie
- Prince of Wales Hospital — Randwick
- Toowoomba Hospital — Toowoomba
- Flinders Medical Centre — Bedford PK
- The Alfred Hospital — Melbourne
- Perth Blood Institute — West Perth
South Korea · 7 центров
Список центров уточняется — проверьте первичный протокол.
Аргентина · 6 центров
- Hospital Aleman — CABA
- CEMIC — Caba
- FUNDALEU — Caba
- Hospital Italiano de Buenos Aires — Ciudad Autonoma Buenos Aires
- Instituto Alexander Fleming (Iaf) — Ciudad Autonoma Buenos Aires
- Cice 9 de Julio Sanatorio 9 de Julio — San Miguel de Tucumán
Польша · 6 центров
Список центров уточняется — проверьте первичный протокол.
Великобритания · 6 центров
Список центров уточняется — проверьте первичный протокол.
Канада · 5 центров
- London Health Sciences Centre — London
- The Ottawa Hospital Cancer Centre — Ottawa
- Centre Integre de Sante Et de Services Sociaux de La Monteregie Centre — Greenfield Park
- Jewish General Hospital — Montreal
- Unite de Recherche Clinique Du Cisss Des Laurentides — SaintJerome
Turkey (Türkiye) · 5 центров
Список центров уточняется — проверьте первичный протокол.
Чехия · 4 центра
- Fakultni Nemocnice Brno — Brno
- Fakultni Nemocnice Hradec Kralove — Hradec Králové
- Fakultni Nemocnice Ostrava — Ostrava
- Vseobecna Fakultni Nemocnice V Praze — Prague
Нидерланды · 1 центр
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT06846671 · BGB-16673-302 · 2024-518893-15-00