Recruiting 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

Phase III Interventional Chronic Lymphocytic Leukemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Sonrotoclax, Zanubrutinib, Acalabrutinib, Venetoclax.
Who it may be relevant to: Registry conditions: Chronic Lymphocytic Leukemia. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Australia, Brazil, Canada, China +12
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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).

Interventions

Drug Sonrotoclax
Administered orally.
Drug Zanubrutinib
Administered orally.
Drug Acalabrutinib
Administered orally.
Drug Venetoclax
Administered orally.

Primary outcome measures

Progression-Free Survival (PFS) as Determined by Independent Review Committee (IRC) [Time frame: Up to approximately 70 months]
Rate of Undetectable Minimal Residual Disease at < 10^-4 sensitivity (uMRD4) [Time frame: Up to approximately 16 months]

Secondary outcome measures (11)

PFS in High-Risk Participants [Time frame: Up to approximately 70 months]
Overall Survival (OS) [Time frame: Up to approximately 70 months]
Overall Response Rate (ORR) as Determined by IRC [Time frame: Up to approximately 70 months]
Rate of Undetectable Minimal Residual Disease at < 10^-5 sensitivity (uMRD5) [Time frame: Up to approximately 16 months]
Number of Participants with Adverse Events [Time frame: Up to approximately 70 months]
PFS Determined by Investigator Assessment [Time frame: Up to approximately 70 months]
Complete Response Rate (CRR) by IRC and Investigator Assessment [Time frame: Up to approximately 70 months]
ORR Determined by Investigator Assessment [Time frame: Up to approximately 70 months]
Duration of Response (DOR) [Time frame: Up to approximately 70 months]
Time to Next Treatment (TTNT) [Time frame: Up to approximately 70 months]
Change from Baseline in Score on European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL)-409 Questionnaire [Time frame: At baseline and up to approximately 70 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Treatment

Study locations

China · 20 centers

Peking Union Medical College Hospital — Beijing
The First Affiliated Hospital of Chongqing Medical University — Chongqing
The First Affiliated Hospital of Fujian Medical University — Fuzhou
Zhujiang Hospital of Southern Medical University — Guangzhou
Sun Yat Sen University Cancer Center Huangpu Branch — Guangzhou
The First Affiliated Hospital of Guangxi Medical University — Nanning
Guizhou Provincial Peoples Hospital — Guiyang
Harbin Medical University Cancer Hospital — Harbin
… and 12 more centers

Australia · 8 centers

Blacktown Cancer and Haematology Centre — Blacktown
Concord Repatriation General Hospital — Concord
Genesiscare North Shore — St Leonards
Princess Alexandra Hospital — Woolloongabba
Monash Health — Clayton
Austin Health — Heidelberg
Cabrini Hospital Malvern — Malvern
The Alfred Hospital — Melbourne

United States · 7 centers

City of Hope National Medical Center — Duarte
Stanford Cancer Institute — Palo Alto
Northwestern University — Chicago
Midwestern Regional Medical Center — Zion
Ochsner Clinic Foundation — New Orleans
University of Nebraska Medical Center — Omaha
Fred Hutchinson Cancer Research Center — Seattle

France · 7 centers

Centre de Lutte Contre Le Cancer Institut Bergonie — Bordeaux
Chu Clermont Ferrand Therapie Cellulaire and Hematolo — ClermontFerrand
Centre Hospitalier Le Mans — Le Mans
Hopital Claude Huriez Chu Lille — Lille
Centre Leon Berard — Lyon
Chu Montpellier Hopital Saint Eloi — Montpellier
Iuc Toulouse Oncopole — Toulouse

Canada · 6 centers

Bc Cancer Victoria — Victoria
Juravinski Cancer Centre — Hamilton
Ciusss Nim Hscm — Montreal
Jewish General Hospital — Montreal
Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie ( — Québec
Ciusss de Lestrie Chus — Sherbrooke

Czechia · 6 centers

Fakultni Nemocnice Brno — Brno
Fakultni Nemocnice Hradec Kralove — Hradec Králové
Fakultni Nemocnice Olomouc — Olomouc
Fakultni Nemocnice Ostrava — Ostrava
Fakultni Nemocnice Plzen — PLZE
Vseobecna Fakultni Nemocnice V Praze — Prague

Italy · 5 centers

Irccs Azienda Ospedaliero Universitaria Bologna — Bologna
Aou Careggi, Servizio Sanitario Toscana — Florence
Ospedale San Raffaele — Milan
Azienda Ospedaliera Di Padova — Padova
Fondazione Policlinico Universitario Agostino Gemelli — Roma

New Zealand · 5 centers

North Shore Hospital — Auckland
Auckland City Hospital — Auckland
Health New Zealand Canterbury — Christchurch
Dunedin Hospital — Dunedin
Wellington Regional Hospital (Ccdhb) — Wellington

Poland · 5 centers

Szpital Specjalist W Brzozowie,Podkarpacki Osrodek Onkologiczny — Brzozów
Pratia Onkologia Katowice — Katowice
Pratia McM Krakow — Krakow
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie — Lublin
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu — Wroclaw

South Korea · 5 centers