A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

590

Participants

Timeline

Start Date

October 31, 2017

Primary Completion Date

May 7, 2021

Study Completion Date

September 30, 2026

Conditions
Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma
Interventions
DRUG

Zanubrutinib

Administered as two 80-milligram (mg) capsules by mouth twice a day (160 mg twice a day)

DRUG

Bendamustine

Administered intravenously (IV) at a dose of 90 mg/m\^2/day on the first 2 days of each cycle for 6 cycles.

DRUG

Rituximab

Administered intravenously (IV) at a dose of 375 mg/m\^2 on day 0 of cycle 1, and at a dose of 500 mg/m\^2 on day 1 of cycles 2 to 6

DRUG

Venetoclax

400 mg tablets administered orally once daily.

Trial Locations (158)

970

Hualien Tzu Chi Hospital, Hualien City

1023

Auckland City Hospital, Auckland

1090

Universitair Ziekenhuis Brussel, Brussels

1340

Clinique Saint Pierre, Ottignies

2139

Concord Repatriation General Hospital, Concord

2145

Westmead Hospital, Westmead

2298

Calvary Mater Newcastle, Waratah

2487

The Tweed Valley Hospital, Cudgen

3000

Peter Maccallum Cancer Centre, Melbourne

3065

St Vincents Hospital Melbourne, Fitzroy

3112

Tauranga Hospital, Tauranga

3128

Box Hill Hospital, Box Hill

3168

Monash Health, Clayton

3199

Peninsula Private Hospital, Frankston

4000

Centre Hospitalier Universitaire (Chu) de Liege Site Du Sart Tilman, Liège

4010

Krankenhaus Der Barmherzigen Schwestern Linz, Linz

4021

Allgemeines Krankenhaus Der Stadt Linz, Linz

4029

Royal Brisbane and Womens Hospital, Herston

4066

Icon Cancer Centre Wesley, Auchenflower

4102

Princess Alexandra Hospital, Brisbane

4442

Palmerston North Hospital, Palmerston North

4600

Klinikum Wels Grieskirchen, Wels

5000

Royal Adelaide Hospital, Adelaide

5011

The Queen Elizabeth Hospital, Woodville South

5020

Universitatsklinik Fur Innere Medizin Iii Universitatsklinikum Der Pmu Landeskrankenhaus Salzburg, Salzburg

5530

Centre Hospitalier Universitaire Universite Catholique de Louvain Site Godinne, Yvoir

6000

Royal Perth Hospital, Perth

6020

Medizinische Universitatsklinik Innsbruck, Innsbruck

7000

Royal Hobart Hospital, Hobart

8011

Christchurch Hospital, Christchurch

9000

Universitair Ziekenhuis Gent, Ghent

10000

Vseobecna Fakultni Nemocnice V Praze, Prague

10029

Icahn School of Medicine At Mount Sinai, New York

10032

Columbia University Medical Center, New York

10126

Ao Citta Della Salute E Della Scienza Di Torino Presidio O, Torino

13009

Institut Paoli Calmettes, Marseille

14033

Chu Caen Normandie, Caen

14642

University of Rochester, Rochester

20122

Fondazione Irccs Ca Granda Ospedale Maggiore Policlinico, Milan

20132

Ospedale San Raffaele, Milan

20162

Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda, Milan

22903

University of Virginia, Charlottesville

23561

Taipei Medical University Shuang Ho Hospital, New Taipei City

25123

Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia, Brescia

27710

Duke University, Durham

28006

Hospital de La Princesa, Madrid

28027

Clinica Universidad de Navarra, Madrid

28222

Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda

30912

Augusta University, Augusta

31008

Clinica Universidad de Navarra Pamplona, Pamplona

33076

Centre de Lutte Contre Le Cancer Institut Bergonie, Bordeaux

33604

Groupe Hospitalier Du Haut Leveque, Pessac

35033

Hopital Pontchaillou, Rennes

37000

Chu Tours Hopital Bretonneau Service Pneumologie, Tours

37203

Tennessee Oncology, Pllc Nashville, Nashville

41124

Universita Degli Studi Di Modena Azienda Ospedaliere Policlinco, Modena

44093

Centre Hospitalier Universitaire Nantes Hotel Dieu, Nantes

46026

Hospital Universitari I Politecnic La Fe, Valencia

47014

Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst, Meldola

48121

Azienda Unita Sanitaria Locale Di Ravenna, Ravenna

50005

Fakultni Nemocnice Hradec Kralove, Hradec Králové

50009

Hospital de Dia Quironsalud Zaragoza, Zaragoza

51056

Hopital Robert Debre, Reims

54511

Chu Nancy Hopital Brabois, VandoeuvrelesNancy

57201

Prairie Lakes Healthcare System, Watertown

60611

Northwestern University, Chicago

62500

Fakultni Nemocnice Brno, Brno

63110

Washington University, St Louis

64132

Research Medical Center, Kansas City

69495

Chu Hopital Lyon Sud, PierreBenite

72037

Centre Hospitalier Le Mans, Le Mans

75013

Hopital de La Pitie Salpetriere, Paris

75185

Uppsala Akademiska Sjukhus, Uppsala

76038

Centre Henri Becquerel, Rouen

77900

Fakultni Nemocnice Olomouc, Olomouc

79410

Joe Arrington Cancer Research and Treatment Center, Lubbock

85925

Centre Hospitalier Departemental de Vendee, La Roche-sur-Yon

86000

Centre Hospitalier Universitaire de Poitier Hopital de La Miletrie Hopital Jean Bernard, Poitiers

87042

Centre Hospitalier Universitaire Limoges Chu de Limoges, Limoges

89169

Comprehensive Cancer Centers of Nevada, Las Vegas

95107

Centre Hospitalier Victor Dupouy Dargenteuil, Argenteuil

97239

Oregon Health and Science University, Portland

98108

Va Puget Sound Health Care System, Seattle

98109

Fred Hutchinson Cancer Research Center, Seattle

100000

Peking University Third Hospital, Beijing

100050

Beijing Friendship Hospital, Capital Medical University, Beijing

100225

National Taiwan University Hospital East Campus, Taipei

100730

Peking Union Medical College Hospital, Beijing

115478

N N Blokhin Russian Cancer Research Center Konstantin Laktionov, Moscow

Russian Academy of Advanced Medical Studies, City Clinical Hospital, Moscow

130021

The First Hospital of Jilin University, Changchun

191024

Fgu Russian Scientific Research Institute of Hematology and Transfusiology, Saint Petersburg

210029

Jiangsu Province Hospital, Nanjing

214023

Wuxi Peoples Hospital, Wuxi

215006

The First Affiliated Hospital of Soochow University Branch Shizi, Suzhou

230000

Anhui Provincial Hospital, Hefei

248000

Kaluga Regional Hospital, Kaluga

300020

Institute of Hematology and Hospital of Blood Disease, Tianjin

300053

Tula Area Clinical Hospital, Tula

300060

Tianjin Medical University Cancer Institute and Hospital, Tianjin

310003

The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou

330006

The First Affiliated Hospital of Nanchang University Branch Donghu, Nanchang

350001

Fujian Medical University Union Hospital, Fuzhou

354057

State Healthcare Institution Oncologic Dispensary No Health Department of Krasnodar Region, Sochi

362000

Quanzhou First Affliated Hospital of Fujian Medical University, Quanzhou

390039

Ryazan Regional Clinical Hospital, Ryazan

400037

Second Affiliated Hospital of Army Medical University (Xinqiao Hospital), Chongqing

400138

State Budgetary Healthcare Institution Volgograd Regional Clinical Oncology Dispensary, Volgograd

420029

Clinical Oncology Dispensary, Kazan

430022

Union Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan

440071

State Budgetary Healthcare Institution Regional Clinical Dispensary, Penza

450000

Henan Cancer Hospital, Zhengzhou

510080

Guangdong Provincial Peoples Hospital, Guangzhou

603126

Nizhniy Novgorod Regional Clinical Hospital Nasemashko, Nizhny Novgorod

610041

West China Hospital, Sichuan University, Chengdu

614077

State Budgetary Healthcare Institution of Perm Krai Clinical Medical Sanitary Establishment, Perm

620102

Sverdlovsk Regional Clinical Hospital, Yekaterinburg

620137

Central City Hospital, Yekaterinburg

650066

Kemerovo Regional Clinical Hospital Na Sv Belyaev, Kemerovo

02215

Dana Farber Cancer Institute, Boston

07932

Summit Medical Group, Florham Park

00161

Universita Degli Studi La Sapienza, Roma

00168

Fondazione Policlinico Universitario Agostino Gemelli, Roma

05100

Azienda Ospedaliera S Maria Di Terni, Terni

0622

North Shore Hospital, Takapuna

36-200

Szpital Specjalist W Brzozowie,Podkarpacki Osrodek Onkologiczny, Brzozów

41-500

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich, Chorzów

80-219

Copernicus Podmiot Leczniczy Sp Z Oo Wojewodzkie Centrum Onkologii, Gdansk

81-519

Szpitale Pomorskie Spolka Z Ograniczona Odpowiedzialnoscia, Gdynia

44-101

Centrum Onkologii Instytut Im Marii Sklodowskiej Curie, Oddzial W Gliwicach, Gliwice

30-510

Malopolskie Centrum Medyczne Sc, Krakow

59-220

Wojewodzki Szpital Specjalistyczny W Legnicy, Legnica

93-510

Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi, Lodz

20-090

Centrum Onkologii Ziemi Lubelskiej, Lublin

08916

Hospital Universitari Germans Trias I Pujol, Badalona

08003

Hospital Del Mar, Barcelona

08908

Institut Catala Doncologia, Barcelona

501 82

Medicinkliniken, Borås

416 85

Sahlgrenska Universitetssjukhuset, Gothenburg

221 85

Skanes Universitetssjukhus I Lund, Lund

701 85

Universitetssjukhuset Orebro, Örebro

171 76

Karolinska Universitetssjukhuset Solna, Stockholm

B9 5SS

Birmingham Heartlands Hospital, Birmingham

BH7 7DW

The Royal Bournemouth and Christchurch Hospitals Nhs Foundation, Bournemouth

CB2 0QQ

Cambridge University Hospitals Nhs Foundation Trust, Cambridge

CT1 3NG

Kent and Canterbury Hospital, Canterbury

M20 4BX

The Christie Hospital, Greater Manchester

LS9 7TF

The Leeds Teaching Hospitals Nhs Trust, Leeds

EC1M 6BQ

Barts and the London Nhs Trust, London

SW3 6JJ

Royal Marsden Hospital, London

W1G 6AD

Sarah Cannon Research Institute Uk, London

ME16 9QQ

Maidstone and Tunbridge Wells Nhs Trust, Kent Oncology Centre, Maidstone Hospital, Maidstone

NR4 7UY

Norfolk and Norwich University Hospitals Nhs Foundation Trust, Norwich

NG51PB

Nottingham University Hospitals Nhs Trust, Nottingham

PL6 8DH

Derriford Hospital, Plymouth

SO16 6YD

Southampton General Hospital, Southampton

SR4 7TP

Sunderland Royal Hospital, Sunderland

WV10 0QP

The Royal Wolverhampton Nhs Trust, Wolverhampton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

BeiGene

INDUSTRY