A Study Comparing the Efficacy and Safety of Polatuzumab Vedotin With Rituximab-Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab-Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Diffuse Large B-Cell Lymphoma

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

1,000

Participants

Timeline

Start Date

November 16, 2017

Primary Completion Date

July 5, 2026

Study Completion Date

July 5, 2026

Conditions
Diffuse Large B-Cell Lymphoma
Interventions
DRUG

Polatuzumab Vedotin

Polatuzumab vedotin IV infusion will be administered as per the schedule specified in the respective arm.

DRUG

Rituximab

Rituximab IV infusion will be administered as per the schedule specified in the respective arm.

DRUG

Cyclophosphamide

Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.

DRUG

Doxorubicin

Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.

DRUG

Vincristine

Vincristine IV infusion will be administered as per the schedule specified in the respective arm.

DRUG

Vincristine Placebo

Placebo matching to vincristine will be administered as per the schedule specified in the respective arm.

DRUG

Prednisone

Prednisone PO will be administered as per the schedule specified in the respective arm.

DRUG

Polatuzumab vedotin Placebo

Placebo matching to polatuzumab vedotin will be administered as per the schedule specified in the respective arm.

Trial Locations (216)

736

Chi-Mei Hospital, Liouying, Tainan City

807

Kaohsiung Medical University Hospital, Cancer Center, Kaohsiung City

1023

Auckland City Hospital, Cancer and Blood Research, Auckland

1090

Medizinische Universität Wien, Vienna

1160

Wiener Gesundheitsverbund ? Klinik Ottakring, Vienna

2031

Prince of Wales Hospital, Randwick

2139

Concord Repatriation General Hospital, Concord

2145

Westmead Hospital, Westmead

2217

St George Hospital, Kigarah

2298

Calvary Mater Newcastle, Waratah

3084

Austin Hospital, Heidelberg

3168

Monash Medical Centre, Clayton

3240

Waikato Hospital, Hamilton

4031

Universitätsspital Basel Gynäkologie - Onkologie, Basel

4102

Princess Alexandra Hospital Woolloongabba, Woolloongabba

5011

The University of Adelaide - The Queen Elizabeth Hospital (TQEH), Woodville South

5020

Paracelsus Medizinischen Privatuniversitaet-Salzburger Landeskliniken (SALK), Salzburg

5037

Ashford Cancer Center Research, Kurralta Park

5530

CHU UCL Mont-Godinne, Mont-godinne

7100

CH Jolimont - Lobbes (Jolimont), Haine-Saint-Paul

8140

Canterbury Health Laboratories, Christchurch

9000

UZ Gent, Ghent

10002

National Taiwan University Hospital, Taipei

10003

Hospital San Pedro de Alcantara, Cáceres

10016

New York University Cancer Cen, New York

10065

Memorial Sloan Kettering Cancer Center, New York

10604

Memorial Sloan Kettering Cancer Center at Westchester, Harrison

10967

Vivantes Klinikum Am Urban, Berlin

11211

Taipei Veterans General Hospital, Taipei

11725

Memorial Sloan Kettering Cancer Center - Commack, Commack

14000

Institut d'Hématologie de Basse Normandie, Caen

14263

Roswell Park Cancer Institute, Buffalo

14642

University of Rochester Medical Center, Rochester

15232

University of Pittsburgh Medical Center Cancer Center, Pittsburgh

16132

IRCCS AOU San Martino - IST, Genoa

17007

Hospital Universitari Dr. Josep Trueta, Girona

19104

Hospital of the University of Pennsylvania, Philadelphia

19111

Fox Chase Cancer Center, Philadelphia

20007

Georgetown University Medical Center, Washington D.C.

20052

Istituto Nazionale dei Tumori, Monza

21000

CHU de Dijon - Hopital le Bocage, Dijon

21201

University of Maryland, Baltimore

21287

Johns Hopkins University, Baltimore

22027

Centre Hospitalier de Saint Brieuc - Hôpital Yves Le Foll, Saint-Brieuc

22031

Virginia Cancer Specialists, PC, Fairfax

24060

Oncology Associates of Southwest Virginia, Inc., Blacksburg

Azienda Ospedaliera Papa Giovanni XXIII, Bergamo

25030

Hopital Jean Minjoz, Besançon

26506

West Virginia Uni Med. Center - Robert Byrd Health Science, Morgantown

27514

University of North Carolina at Chapel Hill, Chapel Hill

28040

Fundación Jimenez Díaz, Madrid

28100

Azienda Ospedaliero Universitaria Maggiore della Carita di Novara, Novara

28204

Levine Cancer Institute - Clincal Trials Administration, Charlotte

28233

Hospital Quiron Madrid, Madrid

29000

Khmelnytskyi Regional Hospital, Khmelnytskyi

29010

Hospital Universitario Virgen de la Victoria, Málaga

29107

Centre Hospitalier de Quimper Cornouaille (CHIC), Quimper

29425

Medical University of South Carolina Hospital, Charleston

29615

Prisma Health ? Upstate, Greenville

30029

CHU de Nîmes - Hôpital Carémeau, Nîmes

30322

Emory University, Atlanta

31008

Complejo Hospitalario de Navarra, Pamplona

31059

Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O), Toulouse

33076

Institut Bergonie, Bordeaux

33401

Florida Cancer Specialists, West Palm Beach

33604

Hopital Haut-Leveque - Centre Francois Magendie, Pessac

33705

Florida Cancer Specialists & Research Institute, St. Petersburg

34295

CHU Montpellier - Saint ELOI, Montpellier

35033

Hopital Pontchaillou, Rennes

35100

Ege Üniversitesi Tip Fakültesi, Lzmir

35294

University of Alabama at Birmingham, Birmingham

35340

Dokuz Eylul Universitesi Tip Fakultesi, Lzmir

36526

Southern Cancer Center, Daphne

37044

CHU Bretonneau, Tours

37203

Tennessee Oncology - Nashville, Nashville

37403

Greco-Hainesworth Centers for Research, Chattanooga

38000

L'Union Mutualiste de la Gestion des Eaux Claires - Institut Daniel Hollard, Grenoble

38700

Hôpital Albert Michallon, La Tronche

40202

University of Louisville Hospital, Louisville

40447

China Medical University Hospital, Taichung

41013

Hospital Universitario Virgen del Rocio, Seville

42270

Pôle de Cancérologie ? CHU de Saint?Etienne', Saint-Priest-en-Jarez

43210

Ohio State University, Columbus

44093

CHU de Nantes - Hotel Dieu, Nantes

44106

University Hospitals Case Medical Center, Cleveland

45147

Universitätsklinikum Essen, Essen

45236

Oncology/Hematology Care Clinical Trials LLC, Cincinnati

48109

University of Michigan Health System, Ann Arbor

48149

Universitatsklinikum Munster, Münster

48201

Karmanos Cancer Center, Detroit

49241

Pusan National University Hospital, Busan

49933

CHU Angers, Angers

54511

CHU de Brabois, Vandœuvre-lès-Nancy

56017

CH Bretagne Atlantique, Vannes

56068

InVO - Institut für Versorgungsforschung in der Onkologie GbR, Koblenz

59000

Hôpital Saint Vincent de Paul, Lille

59037

Hopital Claude Huriez, Lille

60005

Illinois Cancer Specialists, Arlington Heights

63110

Washington University, St Louis

64109

Centre Hospitalier de La Cote Basque, Bayonne

66046

Hopital Saint Jean, Perpignan

67091

Chru de Strasbourg, Strasbourg

69008

Centre Leon Berard, Lyon

69120

Universitaetsklinikum Heidelberg, Heidelberg

69310

CHU Lyon Sud - Service Hématologie, Pierre-Bénite

70121

Ochsner Medical Center, New Orleans

72015

Clinique Victor Hugo - Centre Jean Bernard, Le Mans

73011

CH Metropole de Savoie, Chambéry

75475

Hôpital Saint-Louis, Paris

75702

Texas Oncology-Tyler, Tyler

75743

Gh Necker Enfants Malades, Paris

76038

Centre Henri Becquerel, Rouen

78229

Texas Oncology San Antonio Medical Center, San Antonio

78705

Texas Oncology-Austin Midtown, Austin

79007

MNE Lviv Territorial Medical Association Clinical Hospital for Palliative Care, Lviv

80012

Rocky Mountain Cancer Centers, LLP, Aurora

80054

CHU Amiens - Hopital Sud, Amiens

84112

University of Utah, Salt Lake City

85025

CHD Vendée, La Roche-sur-Yon

86021

CHU de Poitiers, Poitiers

87042

Hopital Uni Ire Dupuytren, Limoges

90095

Ronald Reagan UCLA Medical Center, Los Angeles

91010

City of Hope, Duarte

94010

Hopital Henri Mondor, Créteil

94805

Institut Gustave Roussy, Villejuif

97225

Northwest Cancer Specialists - Portland (SW Barnes Rd), Portland

97239

Oregon HSU, Portland

97401

Oncology Associates of Oregon, P.C, Eugene

98101

Seattle Cancer Care Alliance, Seattle

100142

Beijing Cancer Hospital, Beijing

130021

The First Hospital of Jilin University, Changchun

194291

Leningrad Regional Clinical Hospital, Saint Petersburg

200025

Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai

200032

Fudan University Shanghai Cancer Center, Shanghai

Shanghai East Hospital, Tongji University, Shanghai

210009

Jiangsu Cancer Hospital, Nanjing

280146

Hospital Universitario La Paz, Madrid

300020

Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences, Tianjin

300060

Tianjin Medical University Cancer Institute & Hospital, Tianjing

310003

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

350014

Fujian Provincial Cancer Hospital, Fuzhou

430022

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

450008

Henan Cancer Hospital, Zhengzhou

510060

Sun Yet-sen University Cancer Center, Guangzhou

33901-8101

Florida Cancer Specialists - Fort Myers (New Hampshire Ct), Fort Myers

02114

Massachusetts General Hospital, Boston

02115

Dana Farber Cancer Institute, Boston

07645

Memorial Sloan Kettering Bergen, Montvale

81520-060

Hospital Erasto Gaertner, Curitiba

DUMMY_VALUE

Hospital das Clinicas - UFRGS, Porto Alegre

Universita degli Studi Di Brescia - Azienda Ospedaliera Spedali Civili di Brescia, Brescia

"Universita degli Studi di Roma ''La Sapienza - Clinica Ematologica", Rome

AUSL di Reggio Emilia, IRCCS, P.O. Arcispedale Santa Maria Nuova, Reggio Emilia

Pusan National University Yangsan Hospital, Yangsan

Communal Institution 'Cherkassy Regional Oncology Dispensary' of the Cherkassy Regional Council, Cherkassy

13083-878

Centro de Hematologia e Hemoterapia - HEMOCENTRO UNICAMP, Campinas

05403-000

Hospital das Clinicas - FMUSP, São Paulo

T6G 1Z2

University of Alberta Hospital, Edmonton

V5Z 4E6

BC Cancer ? Vancouver, Vancouver

MB R3E 0V9

CancerCare Manitoba (CCMB), Winnipeg

K1H 8L6

The Ottawa Hospital, Ottawa

M4N 3M5

Sunnybrook Health Sciences Centre, Toronto

H1T 2M4

CIUSSS de l Est de l Ile de Montreal - Hopital Maisonneuve Rosemont, Montreal

G1J 1Z4

CHU de Quebec-Universite Laval, Québec

500 05

Fakultni Nemocnice Hradec Kralove (FNHK), Hradec Králové

775 20

Fakultni nemocnice Olomouc, Olomouc

708 52

Fakultni nemocnice Ostrava, Ostrava - Poruba

100 34

Fakultni Nemocnice Kralovske Vinohrady (FNKV), Prague

128 08

Všeobecná fakultní nemocnice v Praze, Prague

06189

Centre Antoine Lacassagne, Nice

06847

Städtisches Klinikum Dessau, Dessau

06120

Universitaetsklinikum Halle (Saale), Halle

00126

Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino, Turin

464-8681

Aichi Cancer Center, Aichi

260-8717

Chiba Cancer Center, Chiba

277-8577

National Cancer Center Hospital East, Chiba

260-8670

Chiba University Hospital, Chūōku

811-1395

National Hospital Organization Kyushu Cancer Center, Fukuoka

812-8582

Kyushu University Hospital, Fukuoka

734-8551

Hiroshima University Hospital, Hiroshima

060-8648

Hokkaido University Hospital, Hokkaido

650-0047

Kobe City Medical Center General Hospital, Hyōgo

259-1193

Tokai University Hospital, Isehara-shi

860-8556

Kumamoto University Hospital, Kumamoto

602-8566

University Hospital Kyoto Prefectural University of Medicine, Kyoto

980-8574

Tohoku University Hospital, Miyagi

545-8586

Osaka Metropolitan University Hospital, Osaka

565-0871

The University of Osaka Hospital, Osaka

589-8511

Kindai University Hospital, Osaka

329-0498

Jichi Medical University Hospital, Tochigi

104-0045

National Cancer Center Hospital, Tokyo

135-8550

The Cancer Institute Hospital of JFCR, Tokyo

93-510

Wojewódzki Szpital Specjalistyczny im. M. Kopernika, ?ód?

41-500

Samodzielny Publiczny Zak?ad Opieki Zdrowotnej Zespó? Szpitali Miejskich w Chorzowie, Chorzów

30-727

PRATIA MCM Kraków, Krakow

60-631

SPZOZ Ministerstwa Spraw Wewn?trznych i Administracji w Poznaniu, Późna

04-141

Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy, Warsaw

410-769

National Cancer Center, Gyeonggi-do

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

08035

Hospital Universitari Vall d'Hebron, Barcelona

08036

Hospital Clinic Barcelona, Barcelona

08041

Hospital de la Santa Creu i Sant Pau, Barcelona

08908

Institut Catala d Oncologia Hospitalet, Barcelona

06700

Ankara University Faculty of Medicine Cebeci Hospital, Ankara

03143

Feofaniya Center of Haematology and Chemotherapy of Haemoblastosis, Kyiv

CB2 0QQ

Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital, Cambridge

CT1 3NG

East Kent Hospitals University NHS Foundation Trust, Canterbury

LE1 5WW

University Hospitals of Leicester NHS Trust - Leicester Royal Infirmary, Leicester

EC1A 7BE

Barts Health NHS Trust, London

M20 4BX

The Christie NHS Foundation Trust, Manchester

NE7 7DN

The Newcastle upon Tyne Hospitals NHS Foundation Trust. Freeman Hospital, Newcastle upon Tyne

NG5 1PB

Nottingham City Hospital, Nottingham

OX3 7LE

Oxford University Hospitals NHS Foundation Trust, Oxford

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY