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Набира участници Фаза 3 NCT07277231

A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia

Фаза 3 – широко изпитване преди одобрение
Заболявания: Chronic Lymphocytic Leukemia

Спонсор: BeOne Medicines

Налично на: БГ
Обобщение
The purpose of this study is to investigate the efficacy and safety of fixed-duration sonrotoclax (also known as BGB-11417) plus zanubrutinib (also known as BGB-3111) (SZ) compared with fixed-duration of venetoclax plus acalabrutinib (AV) in participants with previously untreated chronic lymphocytic leukemia (CLL).
Кой може да участва
Inclusion Criteria: * Treatment-naïve (TN) adults with confirmed diagnosis of CLL which requires treatment * Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2 * Measurable disease by Computer Tomography/Magnetic Resonance Imaging * Adequate bone marrow and organ function Exclusion Criteria: * Previous systemic treatment for CLL * Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation * Known central nervous system involvement * History of confirmed progressive multifocal leukoencephalopathy (PML) * Uncontrolled hypertension or clinically significant cardiovascular disease Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Интервенции
Sonrotoclax
DRUG
Zanubrutinib
DRUG
Acalabrutinib
DRUG
Venetoclax
DRUG
Места на провеждане 24
Австралия (7)
Monash Health
Clayton , Victoria
Concord Repatriation General Hospital
Concord , New South Wales
Austin Health
Heidelberg , Victoria
Cabrini Hospital Malvern
Malvern East , Victoria
The Alfred Hospital
Melbourne , Victoria
Genesiscare North Shore
St Leonards , New South Wales
Princess Alexandra Hospital
Woolloongabba , Queensland
Бразилия (2)
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
Porto Alegre
Instituto Dor de Pesquisa E Ensino Sao Paulo
São Paulo
Канада (4)
Ciusss Nim Hscm
Montreal , Quebec
Jewish General Hospital
Montreal , Quebec
Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic)
Québec
Ciusss de Lestrie Chus
Sherbrooke , Quebec
Китай (2)
Jiangsu Province Hospital
Nanjing , Jiangsu
The Second Affiliated Hospital of Xian Jiaotong University
Xi'an , Shaanxi
New Zealand (3)
North Shore Hospital
Auckland
Auckland City Hospital
Auckland
Wellington Regional Hospital (Ccdhb)
Wellington
Южна Корея (5)
The Catholic University of Korea, Seoul St Marys Hospital
SeochoGu , Seoul Teugbyeolsi
Severance Hospital Yonsei University Health System
SeodaemunGu , Seoul Teugbyeolsi
Seoul National University Bundang Hospital
Seongnam-si , Gyeonggi-do
Seoul National University Hospital
Seoul , Seoul Teugbyeolsi
Asan Medical Center
SongpaGu , Seoul Teugbyeolsi
Великобритания (1)
Kings College Hospital
London
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
22.01.2026
Крайна дата
01.11.2031
Регистрационен номер
NCT07277231
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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