A Study to Investigate the Efficacy of Zanubrutinib Plus Rituximab Compared With Bendamustine Plus Rituximab in Adults With Previously Untreated Mantle Cell Lymphoma Who Are Ineligible for Stem Cell Transplantation

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

510

Participants

Timeline

Start Date

August 20, 2019

Primary Completion Date

March 31, 2027

Study Completion Date

December 31, 2027

Conditions
Mantle Cell Lymphoma; Non-Hodgkin Lymphoma
Interventions
DRUG

zanubrutinib

Administered as two 80 mg capsules by mouth twice a day

DRUG

bendamustine

Administered intravenously at a dose of 90 mg/m2/day on Days 1 and 2 of Cycles 1 to 6

DRUG

rituximab

Administered intravenously at a dose of 375 mg/m2 on Day 1 of Cycles 1 to 6

Trial Locations (176)

114

Tri Service General Hospital, Taipei

704

National Cheng Kung University Hospital, Tainan City

736

Chi Mei Hospital Liouying, Tainan City

1090

Medical University Vienna Oncology, Vienna

Universitair Ziekenhuis Brussel, Brussels

2010

Saint Vincents Hospital Sydney, Darlinghurst

2139

Concord Repatriation General Hospital, Concord

2250

Gosford Hospital, Gosford

2298

Calvary Mater Newcastle, Waratah

2487

The Tweed Valley Hospital, Cudgen

2605

Canberra Hospital, Garran

2650

Uz Antwerpen, Edegem

3022

National Cancer Institute, Kiev

3065

St Vincents Hospital Melbourne, Fitzroy

3112

Tauranga Hospital, Tauranga

3168

Monash Health, Clayton

3199

Peninsula Private Hospital, Frankston

3220

Barwon Health the Geelong Hospital, Geelong

4000

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

4020

Ordensklinikum Linz Gmbh Elisabethinen, Linz

4101

Icon Cancer Foundation, South Brisbane

4575

Sunshine Coast Hospital and Health Service, Birtinya

5020

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

5042

Flinders Medical Centre, Bedford PK

5530

Centre Hospitalier Universitaire Universite Catholique de Louvain Site Godinne, Yvoir

6000

Royal Perth Hospital, Perth

6500

Gazi University, Ankara

7000

Royal Hobart Hospital, Hobart

8000

Az Sint Jan Brugge, Bruges

8011

Christchurch Hospital (Canterbury Health Laboratories), Christchurch

8500

Az Groeninge Campus Loofstraat, Kortrijk

10029

Icahn School of Medicine At Mount Sinai, New York

10126

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

11590

Clinical Research Alliance, Inc, Westbury

13009

Institut Paoli Calmettes, Marseille

15121

Azienda Ospedaliera Nazionale Ssantonio E Biagio E Cesare Arrigo, Alessandria

15224

West Penn Hospital, Pittsburgh

16132

Azienda Ospedaliera Universitaria San Martino, Genova

17007

Ico Girona, Girona

18009

Cherkasy Regional Oncology Dispensary, Cherkasy

20162

Niguarda Cancer Center Division of Hematology, Milan

22030

Tr Trakya University Health Research and Application Center (Hospital), Edirne

28009

Hospital Universitario Gregorio Maranon, Madrid

28033

Md Anderson Cancer Center Madrid Spain, Madrid

28040

Start Madrid Fundacion Jimenez Diaz, Madrid

28046

Hospital Universitario La Paz, Madrid

28100

Aou Maggiore Della Carita, Novara

29000

Ch Cornouaille, Quimper

29010

Hospital Regional Universitario de Malaga, Málaga

29200

Chru de Brest Hospital Morvan, Brest

31059

Iuc Toulouse Oncopole, Toulouse

33000

Mersin Universitesi Tip Fakultesi Hastanesi, Mersin

33076

Centre de Lutte Contre Le Cancer Institut Bergonie, Bordeaux

34365

Vkv American Hospital, Istanbul

37142

University of Verona, Verona

38043

Chu Grenoble Alpes, Grenoble

40138

Policlinico Sorsola Malpighi, Aou Di Bologna, Bologna

41013

Hospital Universitario Virgen Del Rocio, Seville

42123

Azienda Unita Sanitaria Locale Irccs, Reggio Emilia

42283

Petrus Krankenhaus Wuppertal, Wuppertal

44093

Centre Hospitalier Universitaire Nantes Hotel Dieu, Nantes

48109

University of Michigan Health System, Ann Arbor

48121

Unita Di Ematologia, Dipartimento Di Ematologia Ed Oncologia, Ravenna

49102

Municipal Non Profit Enterprise City Clinical Hospital, Dnipro

50937

Uniklinik Koln (Aor), Cologne

53100

Aou Senese Policlinico Santa Maria Alle Scotte, Siena

56126

Aou Pisana, Stabilimento Di Santa Chiara, Pisa

59000

Hopital Claude Huriez Chu Lille, Lille

60612

Rush University Medical Center, Chicago

69120

Universitatsklinikum Heidelberg, Heidelberg

69495

Chu Hopital Lyon Sud, PierreBenite

72037

Centre Hospitalier Le Mans, Le Mans

75005

Institut Curie, Paris

75015

Necker University Hospital, Paris

79044

Si Institute of Blood Pathology and Transfusion Medicine Nams of Ukraine, Hematology Department, Lviv

79410

Joe Arrington Cancer Research and Treatment Center, Lubbock

81377

Dept of Medicine Iii, University Hospitallmu, Munich

86000

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

89081

Universitaetsklinikum Ulm, Innere Medizin Iii, Ulm

89169

Comprehensive Cancer Centers of Nevada, Las Vegas

90146

Aoor Villa Sofia Cervello, Palermo

92868

Chao Family Comprehensive Cancer Center, Orange

97213

Providence Portland Medical Center, Portland

98109

Seattle Cancer Care Alliance, Seattle

100044

Peking University Peoples Hospital, Beijing

100050

Beijing Friendship Hospital, Capital Medical University, Beijing

110004

Shengjing Hospital of China Medical University, Shenyang

125284

Clinical Hospital, Sp Botkin, Moscow

130021

Jilin Cancer Hospital, Changchun

The First Hospital of Jilin University, Changchun

142770

Gbuz Mmcc Kommunarka Dzm, Moscow

150000

Harbin Medical University Cancer Hospital, Harbin

191024

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

194291

Leningrad Regional Clinic and Hospital, Saint Petersburg

200000

Fudan University Shanghai Cancer Center, Shanghai

200120

Shanghai East Hospital, Shanghai

210008

Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School, Nanjing

210029

Jiangsu Province Hospital, Nanjing

221000

The Affiliated Hospital of Xuzhou Medical University, Xuzhou

300020

Institute of Hematology and Hospital of Blood Disease, Tianjin

300060

Tianjin Medical University Cancer Institute and Hospital, Tianjin

310003

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

310022

Zhejiang Cancer Hospital, Hangzhou

315000

Hwa Mei Hospital, University of Chinese Academy of Sciences (Ningbo No Hospital), Ningbo

330006

The First Affiliated Hospital of Nanchang University Branch Donghu, Nanchang

350001

Fujian Medical University Union Hospital, Fuzhou

362000

Quanzhou First Affliated Hospital of Fujian Medical University, Quanzhou

410013

Hunan Cancer Hospital, Changsha

430030

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

450000

Henan Cancer Hospital, Zhengzhou

510060

Sun Yat Sen University Cancer Center, Guangzhou

510080

Guangdong Provincial Peoples Hospital, Guangzhou

510515

Nanfang Hospital of Southern Medical University, Guangzhou

610041

West China Hospital, Sichuan University, Chengdu

700483

Institutul Regional de Oncologie Iasi, Iași

830000

Affiliated Cancer Hospital of Xinjiang Medical University, Ürümqi

02215-5400

Beth Israel Deaconess Medical Center (Bidmc), Boston

77030-4009

The University of Texas Md Anderson Cancer Center, Houston

K1H 8M2

The Ottawa Hospital, Ottawa

J1H 5N4

Ciusss de Lestrie Chus, Sherbrooke

J4V 2H1

Chu Dijon, Dijon

t12DC4A

Cork University Hospital, Cork

D7

Mater Misericordiae University Hospital, Dublin

D8

St Jamess Hospital, Dublin

H91 YR71

University Hospital Galway, Galway

V94F858

University Hospital Limerick, Limerick

X91 ER8E

University Hospital Waterford, Waterford

00161

Universita Degli Studi La Sapienza, Roma

460-0001

National Hospital Organization Nagoya Medical Center, Nagoya

441-8570

Toyohashi Municipal Hospital, Toyohashi

260-8717

Chiba Cancer Center, Chiba

830-0011

Kurume University Hospital, Kurume

730-8619

Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital, Hiroshima

241-8515

Kanagawa Cancer Center, Yokohama

860-0008

National Hospital Organization Kumamoto Medical Center, Kumamoto

980-8574

Tohoku University Hospital, Sendai

710-8602

Kurashiki Central Hospital, Kurashikishi

543-8555

Osaka Red Cross Hospital, Osakashi

104-0045

National Cancer Center Hospital, Chuoku

602-8566

University Hospital, Kyoto Prefectural Univ of Medicine, Kyoto

701-1192

National Hospital Organization Okayama Medical Center, Okayama

545-8586

Osaka Metropolitan University Hospital, Osaka

113-8519

Tokyo Medical and Dental University Hospital, Tokyo

221-0855

Yokohama Municipal Citizens Hospital, Yokohama

4462 RA

Admiraal de Ruijter Ziekenhuis, Goes

9713 GZ

University of Medical Center Groningen (Umcg), Groningen

3435 CM

St Antonius Ziekenhuis, Randd Interne Geneeskunde (F), Nieuwegein

6525 GA

Albert Schweitzer Ziekenhuis, Nijmegen

3015 GD

Erasmus Mc, Rotterdam

2545 CH

Hagaziekenhuis, The Hague

85-168

Szpital Uniwersytecki Nr Im Dr Jana Biziela, Bydgoszcz

41-503

Silesian Healthy Blood Clinic, Chorzów

80-952

Uniwersyteckie Centrum Kliniczne, Gdansk

80-219

Copernicus Podmiot Leczniczy Sp Z Oo Wojewodzkie Centrum Onkologii, Gdask

81-519

Szpitale Pomorskie Spolka Z Ograniczona Odpowiedzialnoscia, Gdynia

30-727

Pratia McM Krakow, 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

02-776

Instytut Hematologii I Transfuzjologii W Warszawie, Warsaw

58-309

Specjalistyczny Szpital Im Dr Alfreda Sokolowskiego, Wałbrzych

50-556

Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu, Wroclaw

1099-023

Instituto Portugues Oncologia de Lisboa Francisco Gentil, Epe, Lisbon

1649-035

Chuln Hospital de Santa Maria, Lisbon

4099-001

Centro Hospitalar Universitario Porto, Porto

4200-072

Instituto Portugues de Oncologia Do Porto Francisco Gentil, Epe, Porto

022328

Institutul Clinic Fundeni, Bucharest

08035

Hospital Universitario Vall Dhebron, Barcelona

08908

Institut Catala Doncologia, Barcelona

08916

Ico Hug Trias I Pujol, Barcelona

06620

Dr Abdurrahman Yurtaslan Oncology Teaching and Research Hospital, Ankara

06700

Hematoloji Ve Hematolik Onkoloji Tani Ve Tedavi Merezi, Ankara

NP7 7EG

Aneurin Bevan University Health Board, Abergavenny

B9 5SS

Birmingham Heartlands Hospital, Birmingham

DY1 2HQ

Russells Hall Hopsital, Dudley

SM2 5PT

Royal Marsden Nhs Foundation Royal Marsden Hospital, Sutton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

BeiGene

INDUSTRY