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RECRUITING
NCT07277231
PHASE3

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

Sponsor: BeOne Medicines

View on ClinicalTrials.gov

Summary

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).

Official title: A Phase 3, Open-Label, Randomized Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Patients With Previously Untreated Chronic Lymphocytic Leukemia

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

500

Start Date

2026-01-22

Completion Date

2031-11

Last Updated

2026-03-18

Healthy Volunteers

No

Interventions

DRUG

Sonrotoclax

Administered orally.

DRUG

Zanubrutinib

Administered orally.

DRUG

Acalabrutinib

Administered orally.

DRUG

Venetoclax

Administered orally.

Locations (14)

Genesiscare North Shore

St Leonards, New South Wales, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Cabrini Hospital Malvern

Malvern East, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Centro Gaucho Integrado de Oncologia Hospital Mae de Deus

Porto Alegre, Brazil

Ciusss Nim Hscm

Montreal, Quebec, Canada

Ciusss de Lestrie Chus

Sherbrooke, Quebec, Canada

Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic)

Québec, Canada

North Shore Hospital

Auckland, New Zealand

Auckland City Hospital

Auckland, New Zealand

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

The Catholic University of Korea, Seoul St Marys Hospital

SeochoGu, Seoul Teugbyeolsi, South Korea

Severance Hospital Yonsei University Health System

SeodaemunGu, Seoul Teugbyeolsi, South Korea

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, South Korea