Trial Title:
Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Participants With Chronic Lymphocytic Leukemia (CLL)
NCT ID:
NCT06073821
Condition:
CLL
Conditions: Official terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Venetoclax
Obinutuzumab
Zanubrutinib
Conditions: Keywords:
CLL
Chronic Lymphocytic Leukemia
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Sonrotoclax
Description:
Administered orally
Arm group label:
Sonrotoclax Plus Zanubrutinib
Other name:
BGB-11417
Intervention type:
Drug
Intervention name:
Zanubrutinib
Description:
Administered orally
Arm group label:
Sonrotoclax Plus Zanubrutinib
Other name:
BGB-3111
Intervention type:
Drug
Intervention name:
Venetoclax
Description:
Administered orally
Arm group label:
Venetoclax Plus Obinutuzumab
Intervention type:
Drug
Intervention name:
Obinutuzumab
Description:
Administered intravenously
Arm group label:
Venetoclax Plus Obinutuzumab
Summary:
The main objective of this study is to compare the efficacy of sonrotoclax plus
zanubrutinib versus venetoclax plus obinutuzumab in participants with chronic lymphocytic
leukemia (CLL)
Detailed description:
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
participant life and control disease-related symptoms.
In this study, participants with CLL, without prior treatment will receive either
venetoclax plus obinutuzumab combination treatment that is considered a standard first
line treatment or receive sonrotoclax plus zanubrutinib. It is hypothesized that
sonrotoclax plus zanubrutinib may be better than venetoclax plus obinutuzumab in treating
CLL.
The main purpose of this study is to compare the duration the participants live without
the CLL getting worse between participants who received venetoclax plus obinutuzumab
versus sonrotoclax plus zanubrutinib. Approximately 640 participants will be included in
this study around the world. Participants will have equal chance to be allocated to
receive either of the treatment combinations.
Criteria for 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 liver function as indicated by aspartate aminotransferase (AST) and alanine
aminotransferase (ALT) ≤ 2.5 x the institutional upper limits of normal (ULNs)
value; serum total bilirubin < 3.0 x ULN
- Adequate renal function as defined as creatinine clearance ≥ 50 milliliters per
minute
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
Note: Other protocol defined criteria may apply
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Alaska Oncology and Hematology, Llc
Address:
City:
Anchorage
Zip:
99508
Country:
United States
Status:
Recruiting
Facility:
Name:
City of Hope National Medical Center
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Facility:
Name:
Valkyrie Clinical Trials
Address:
City:
Los Angeles
Zip:
90067
Country:
United States
Status:
Recruiting
Facility:
Name:
Chao Family Comprehensive Cancer Center
Address:
City:
Orange
Zip:
92868
Country:
United States
Status:
Recruiting
Facility:
Name:
Stanford Medicine
Address:
City:
Stanford
Zip:
94305
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Colorado Cancer Center
Address:
City:
Aurora
Zip:
80014
Country:
United States
Status:
Recruiting
Facility:
Name:
Mount Sinai Comprehensive Cancer Center
Address:
City:
Miami Beach
Zip:
33140
Country:
United States
Status:
Recruiting
Facility:
Name:
Southeastern Regional Medical Center
Address:
City:
Newnan
Zip:
30265
Country:
United States
Status:
Recruiting
Facility:
Name:
Illinois Cancercare, Pc
Address:
City:
Peoria
Zip:
61615
Country:
United States
Status:
Recruiting
Facility:
Name:
Fort Wayne Medical Oncology and Hematology
Address:
City:
Fort Wayne
Zip:
46804
Country:
United States
Status:
Recruiting
Facility:
Name:
Mission Cancer and Blood
Address:
City:
Des Moines
Zip:
50309
Country:
United States
Status:
Recruiting
Facility:
Name:
The University of Kansas Cancer Center
Address:
City:
Westwood
Zip:
66205
Country:
United States
Status:
Recruiting
Facility:
Name:
Norton Cancer Institute Pavilion
Address:
City:
Louisville
Zip:
40207
Country:
United States
Status:
Recruiting
Facility:
Name:
Ochsner Clinic Foundation
Address:
City:
New Orleans
Zip:
70121
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Minnesota
Address:
City:
Minneapolis
Zip:
55455
Country:
United States
Status:
Recruiting
Facility:
Name:
Washington University School of Medicine
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Facility:
Name:
John Theurer Cancer Center Hackensack University Medical Center
Address:
City:
Hackensack
Zip:
07601
Country:
United States
Status:
Recruiting
Facility:
Name:
Rutgers Cancer Institute of New Jersey
Address:
City:
New Brunswick
Zip:
08901
Country:
United States
Status:
Recruiting
Facility:
Name:
Clinical Research Alliance, Inc
Address:
City:
Westbury
Zip:
11590
Country:
United States
Status:
Recruiting
Facility:
Name:
University of North Carolina At Chapel Hill
Address:
City:
Chapel Hill
Zip:
27514
Country:
United States
Status:
Recruiting
Facility:
Name:
Atrium Health Levine Cancer Institute (Lci)
Address:
City:
Charlotte
Zip:
28204
Country:
United States
Status:
Recruiting
Facility:
Name:
Cleveland Clinic Foundation
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Recruiting
Facility:
Name:
The James Cancer Hospital and Solove Research Institute At Ohio State University
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Recruiting
Facility:
Name:
Fox Chase Cancer Center
Address:
City:
Philadelphia
Zip:
19111
Country:
United States
Status:
Recruiting
Facility:
Name:
Virginia Cancer Institute
Address:
City:
Richmond
Zip:
23229
Country:
United States
Status:
Recruiting
Facility:
Name:
Fred Hutchinson Cancer Research Center
Address:
City:
Seattle
Zip:
98109
Country:
United States
Status:
Recruiting
Facility:
Name:
Gunderson Health System
Address:
City:
La Crosse
Zip:
54601
Country:
United States
Status:
Recruiting
Facility:
Name:
Medical College of Wisconsin
Address:
City:
Milwaukee
Zip:
53226
Country:
United States
Status:
Recruiting
Facility:
Name:
Concord Repatriation General Hospital
Address:
City:
Concord
Zip:
2139
Country:
Australia
Status:
Recruiting
Facility:
Name:
Genesiscare North Shore
Address:
City:
St Leonards
Zip:
2065
Country:
Australia
Status:
Recruiting
Facility:
Name:
Pindara Private Hospital
Address:
City:
Benowa
Zip:
4217
Country:
Australia
Status:
Recruiting
Facility:
Name:
Sunshine Coast Hospital and Health Service
Address:
City:
Birtinya
Zip:
4575
Country:
Australia
Status:
Recruiting
Facility:
Name:
Princess Alexandra Hospital
Address:
City:
Brisbane
Zip:
4102
Country:
Australia
Status:
Recruiting
Facility:
Name:
Monash Health
Address:
City:
Clayton
Zip:
3168
Country:
Australia
Status:
Recruiting
Facility:
Name:
St Vincents Hospital Melbourne
Address:
City:
Fitzroy
Zip:
3065
Country:
Australia
Status:
Recruiting
Facility:
Name:
Austin Health
Address:
City:
Heidelberg
Zip:
3084
Country:
Australia
Status:
Recruiting
Facility:
Name:
Cabrini Hospital Malvern
Address:
City:
Malvern
Zip:
3144
Country:
Australia
Status:
Recruiting
Facility:
Name:
The Alfred Hospital
Address:
City:
Melbourne
Zip:
3004
Country:
Australia
Status:
Recruiting
Facility:
Name:
Hollywood Private Hospital
Address:
City:
Nedlands
Zip:
6009
Country:
Australia
Status:
Recruiting
Facility:
Name:
Medizinische Universitatsklinik Innsbruck
Address:
City:
Innsbruck
Zip:
6020
Country:
Austria
Status:
Recruiting
Facility:
Name:
Universitatsklinik Fur Innere Medizin Iii Universitatsklinikum Der Pmu Landeskrankenhaus Salzburg
Address:
City:
Salzburg
Zip:
5020
Country:
Austria
Status:
Recruiting
Facility:
Name:
Hospital Erasto Gaertner
Address:
City:
Curitiba
Zip:
81520-060
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
Address:
City:
Porto Alegre
Zip:
90850-170
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Hospital Das Clinicas Da Faculdade de Medicina de Ribeirao Preto Usp
Address:
City:
Ribeirao Preto
Zip:
14051-140
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Hcfmusp Servico de Hematologia, Hemoterapia E Terapia Celular
Address:
City:
Sao Paulo
Zip:
05402-000
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
Address:
City:
Sao Paulo
Zip:
05653-120
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Centre Integre de Sante Et de Services Sociaux de La Monteregie Centre
Address:
City:
Greenfiled Park
Zip:
J4V 2H1
Country:
Canada
Status:
Recruiting
Facility:
Name:
Unite de Recherche Clinique Du Cisss Des Laurentides
Address:
City:
Montreal SaintJerome
Zip:
J7Z 5T3
Country:
Canada
Status:
Recruiting
Facility:
Name:
Ciusss de Lestrie Chus
Address:
City:
Sherbrooke
Zip:
J1H 5N4
Country:
Canada
Status:
Recruiting
Facility:
Name:
Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic)
Address:
City:
Quebec
Zip:
G1J 1Z4
Country:
Canada
Status:
Recruiting
Facility:
Name:
Fujian Medical University Union Hospital
Address:
City:
Fuzhou
Zip:
350001
Country:
China
Status:
Recruiting
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450000
Country:
China
Status:
Recruiting
Facility:
Name:
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430030
Country:
China
Status:
Recruiting
Facility:
Name:
The First Peoples Hospital of Changzhou
Address:
City:
Changzhou
Zip:
213000
Country:
China
Status:
Recruiting
Facility:
Name:
Jiangsu Province Hospital
Address:
City:
Nanjing
Zip:
210029
Country:
China
Status:
Recruiting
Facility:
Name:
The Second Affiliated Hospital of Nanchang University
Address:
City:
Nanchang
Zip:
330006
Country:
China
Status:
Recruiting
Facility:
Name:
The First Hospital of China Medical University
Address:
City:
Shenyang
Zip:
110001
Country:
China
Status:
Recruiting
Facility:
Name:
West China Hospital, Sichuan University
Address:
City:
Chengdu
Zip:
610041
Country:
China
Status:
Recruiting
Facility:
Name:
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Address:
City:
Chengdu
Zip:
610071
Country:
China
Status:
Recruiting
Facility:
Name:
The First Affiliated Hospital, Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310003
Country:
China
Status:
Recruiting
Facility:
Name:
Fakultni Nemocnice Hradec Kralove
Address:
City:
Hradec Kralove
Zip:
50005
Country:
Czechia
Status:
Recruiting
Facility:
Name:
Fakultni Nemocnice Olomouc
Address:
City:
Olomouc
Zip:
77900
Country:
Czechia
Status:
Recruiting
Facility:
Name:
Fakultni Nemocnice Ostrava
Address:
City:
Ostrava
Zip:
708 00
Country:
Czechia
Status:
Recruiting
Facility:
Name:
Fakultni Nemocnice Plzen
Address:
City:
Plzen
Zip:
323 00
Country:
Czechia
Status:
Recruiting
Facility:
Name:
Vseobecna Fakultni Nemocnice V Praze
Address:
City:
Praha
Zip:
10000
Country:
Czechia
Status:
Recruiting
Facility:
Name:
Centre Hospitalier Le Mans
Address:
City:
Le Mans
Zip:
72037
Country:
France
Status:
Recruiting
Facility:
Name:
Centre Hospitalier Universitaire Nantes Hotel Dieu
Address:
City:
Nantes Cedex
Zip:
44093
Country:
France
Status:
Recruiting
Facility:
Name:
Hopital Prive Du Confluent
Address:
City:
Nantes
Zip:
44277
Country:
France
Status:
Recruiting
Facility:
Name:
Centre Henri Becquerel
Address:
City:
Rouen Cedex
Zip:
76038
Country:
France
Status:
Recruiting
Facility:
Name:
Centrum Fur Haematologie Und Onkologie Bethanien
Address:
City:
Frankfurt
Zip:
60389
Country:
Germany
Status:
Recruiting
Facility:
Name:
Carmel Medical Center
Address:
City:
Haifa
Zip:
3436212
Country:
Israel
Status:
Recruiting
Facility:
Name:
Azienda Ospedaliera Universitaria Policlinico Santorsola Malpighi
Address:
City:
Bologna
Zip:
40138
Country:
Italy
Status:
Recruiting
Facility:
Name:
Istituto Europeo Di Oncologia
Address:
City:
Milano
Zip:
20141
Country:
Italy
Status:
Recruiting
Facility:
Name:
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Address:
City:
Milano
Zip:
20162
Country:
Italy
Status:
Recruiting
Facility:
Name:
Aou Maggiore Della Carita
Address:
City:
Novara
Zip:
28100
Country:
Italy
Status:
Recruiting
Facility:
Name:
Azienda Ospedaliera Di Padova
Address:
City:
Padova
Zip:
35128
Country:
Italy
Status:
Recruiting
Facility:
Name:
National Cancer Center
Address:
City:
Goyangsi
Zip:
10408
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Seoul National University Bundang Hospital
Address:
City:
Seongnamsi
Zip:
13620
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Severance Hospital Yonsei University Health System
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
The Catholic University of Korea, Seoul St Marys Hospital
Address:
City:
Seoul
Zip:
06591
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Meander Medisch Centrum
Address:
City:
Amersfoort
Zip:
3813 TZ
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Amsterdam Umc Vu Mc
Address:
City:
Amsterdam
Zip:
1081 HV
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Noordwest Ziekenhuisgroep
Address:
City:
JD Alkmaar
Zip:
1815
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Albert Schweitzer Ziekenhuis
Address:
City:
Nijmegen
Zip:
6525 GA
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Ikazia Ziekenhuis
Address:
City:
Rotterdam
Zip:
3083 AN
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Auckland City Hospital
Address:
City:
Auckland
Zip:
1023
Country:
New Zealand
Status:
Recruiting
Facility:
Name:
Health New Zealand Canterbury
Address:
City:
Christchurch
Zip:
8011
Country:
New Zealand
Status:
Recruiting
Facility:
Name:
North Shore Hospital
Address:
City:
Takapuna
Zip:
0622
Country:
New Zealand
Status:
Recruiting
Facility:
Name:
Tauranga Hospital
Address:
City:
Tauranga
Zip:
3112
Country:
New Zealand
Status:
Recruiting
Facility:
Name:
Wellington Regional Hospital (Ccdhb)
Address:
City:
Wellington
Zip:
6021
Country:
New Zealand
Status:
Recruiting
Facility:
Name:
Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
Address:
City:
Lodz
Zip:
93-510
Country:
Poland
Status:
Recruiting
Facility:
Name:
Uniwersytecki Szpital Kliniczny Nr W Lublinie
Address:
City:
Lublin
Zip:
20-090
Country:
Poland
Status:
Recruiting
Facility:
Name:
Centralny Szpital Kliniczny Uck Wum
Address:
City:
Warszawa
Zip:
02-097
Country:
Poland
Status:
Recruiting
Facility:
Name:
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu
Address:
City:
Wroclaw
Zip:
50-556
Country:
Poland
Status:
Recruiting
Facility:
Name:
Auxilio Mutuo Cancer Center
Address:
City:
San Juan
Zip:
00917
Country:
Puerto Rico
Status:
Recruiting
Facility:
Name:
Hospital Universitario de Burgos
Address:
City:
Burgos
Zip:
09006
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario de Gran Canaria Dr Negrin
Address:
City:
Las Palmas Gran Canarias
Zip:
35010
Country:
Spain
Status:
Recruiting
Facility:
Name:
Md Anderson Cancer Center Madrid Spain
Address:
City:
Madrid
Zip:
28033
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario de Octubre
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital La Candelaria
Address:
City:
Tenerife
Zip:
38010
Country:
Spain
Status:
Recruiting
Facility:
Name:
Karolinska Universitetssjukhuset Solna
Address:
City:
Stockholm
Zip:
171 76
Country:
Sweden
Status:
Recruiting
Facility:
Name:
Gazi University
Address:
City:
Ankara
Zip:
6500
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Kocaeli Universitesi Tip Fakultesi
Address:
City:
Kocaeli
Zip:
41380
Country:
Turkey
Status:
Recruiting
Facility:
Name:
University Hospitals Dorset Royal Bournemouth Hospital
Address:
City:
Bournemouth
Zip:
BH7 7DW
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Churchill Hospital Oxford University Hospital Nhs Trust
Address:
City:
Headington
Zip:
OX3 7LE
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
The Clatterbridge Cancer Centre Liverpool
Address:
City:
Liverpool
Zip:
L7 8YA
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Kings College
Address:
City:
London
Zip:
SE5 9RS
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Norfolk and Norwich University Hospitals Nhs Foundation Trust
Address:
City:
Norwich
Zip:
NR4 7UY
Country:
United Kingdom
Status:
Recruiting
Start date:
November 11, 2023
Completion date:
December 2032
Lead sponsor:
Agency:
BeiGene
Agency class:
Industry
Source:
BeiGene
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06073821
