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 (POLARIX)

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of Polatuzumab Vedotin in Combination With Rituximab and CHP (R-CHP) Versus Rituximab and CHOP (R-CHOP) in Previously Untreated Patients With Diffuse Large B-Cell Lymphoma

This Phase III, randomized, double-blind, placebo-controlled study will compare the efficacy, safety, and pharmacokinetics of polatuzumab vedotin plus R-CHP versus R-CHOP in participants with previously untreated diffuse large B-cell lymphoma (DLBCL).

Study Overview

• Status: Completed
• Conditions: Diffuse Large B-Cell Lymphoma
• Intervention / Treatment: Drug: Polatuzumab Vedotin; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine Placebo; Drug: Prednisone; Drug: Vincristine; Drug: Polatuzumab vedotin Placebo

• Study Type: Interventional
• Enrollment (Actual): 1000
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Concord, New South Wales, Australia, 2139
      • Concord Repatriation General Hospital
    • Kogarah, New South Wales, Australia, 2217
      • St George Hospital
    • Randwick, New South Wales, Australia, 2031
      • Prince of Wales Hospital
    • Waratah, New South Wales, Australia, 2298
      • Calvary Mater Newcastle
    • Westmead, New South Wales, Australia, 2145
      • Westmead Hospital
  • Queensland
    • Woolloongabba, Queensland, Australia, 4102
      • Princess Alexandra Hospital Woolloongabba
  • South Australia
    • Kurralta Park, South Australia, Australia, 5037
      • Ashford Cancer Center Research
    • Woodville South, South Australia, Australia, 5011
      • The University of Adelaide - The Queen Elizabeth Hospital (TQEH)
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Monash Medical Centre Clayton
    • Heidelberg, Victoria, Australia, 3084
      • Austin Hospital
• Austria
  • Salzburg, Austria, 5020
    • Paracelsus Medizinischen Privatuniversitaet-Salzburger Landeskliniken (SALK)
  • Vienna, Austria, 1090
    • Medizinische Universitat Wien
  • Vienna, Austria, 1160
    • Wiener Gesundheitsverbund ? Klinik Ottakring
• Belgium
  • Ghent, Belgium, 9000
    • UZ Gent
  • Haine-Saint-Paul, Belgium, 7100
    • CH Jolimont - Lobbes (Jolimont)
  • Mont-godinne, Belgium, 5530
    • CHU UCL Mont-Godinne
• Brazil
  • Paraná
    • Curitiba, Paraná, Brazil, 81520-060
      • Hospital Erasto Gaertner
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
      • Hospital de Clinicas de Porto Alegre X
  • São Paulo
    • Campinas, São Paulo, Brazil, 13083-878
      • Centro de Hematologia e Hemoterapia - HEMOCENTRO UNICAMP
    • São Paulo, São Paulo, Brazil, 05403-000
      • Hospital das Clinicas - FMUSP
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • BC Cancer Agency Vancouver Centre
  • Manitoba
    • Winnipeg, Manitoba, Canada, MB R3E 0V9
      • CancerCare Manitoba (CCMB)
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • The Ottawa Hospital
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre
  • Quebec
    • Montreal, Quebec, Canada, H1T 2M4
      • CIUSSS de l Est de l Ile de Montreal - Hopital Maisonneuve Rosemont
    • Québec, Quebec, Canada, G1J 1Z4
      • Hôpital de l'Enfant-Jésus
• China
  • Beijing, China, 100142
    • Beijing Cancer Hospital
  • Changchun, China, 130021
    • The First Hospital of Jilin University
  • Hangzhou, China, 310003
    • The First Affiliated Hospital of College of Medicine, Zhejiang University
  • Nanjing, China, 210009
    • Jiangsu Cancer Hospital
  • Shanghai, China, 200032
    • Fudan University Shanghai Cancer Center
  • Shanghai, China, 200025
    • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
  • Shanghai, China, 200120
    • Shanghai East Hospital, Tongji University
  • Tianjin, China, 300020
    • Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
  • Wuhan, China, 430022
    • Union Hospital Tongji Medical College Huazhong University of Science and Technology
  • Zhengzhou, China, 450008
    • Henan Cancer Hospital
• Czechia
  • Hradec Králové, Czechia, 500 05
    • Fakultni Nemocnice Hradec Kralove (FNHK)
  • Olomouc, Czechia, 779 00
    • Fakultni nemocnice Olomouc
  • Prague, Czechia, 128 08
    • Vseobecna fakultni nemocnice v Praze
  • Prague, Czechia, 100 34
    • Fakultní nemocnice Královské Vinohrady (FNKV)
• France
  • Amiens, France, 80054
    • CHU Amiens - Hopital Sud
  • Angers, France, 49933
    • CHU Angers
  • Bayonne, France, 64109
    • Centre Hospitalier de La Côte Basque
  • Bordeaux, France, 33076
    • Institut Bergonie
  • Caen, France, 14000
    • Institut d'Hématologie de Basse Normandie
  • Chambéry, France, 73011
    • CH Métropole de Savoie
  • Créteil, France, 94010
    • Hopital Henri Mondor
  • Dijon, France, 21000
    • CHU de Dijon - Hôpital le Bocage
  • Grenoble, France, 38000
    • L'Union Mutualiste de la Gestion des Eaux Claires - Institut Daniel Hollard
  • La Roche-sur-Yon, France, 85025
    • CHD Vendee
  • La Tronche, France, 38700
    • Hôpital Albert Michallon
  • Le Mans, France, 72015
    • Clinique Victor Hugo - Centre Jean Bernard
  • Lille, France, 59037
    • Hopital Claude Huriez
  • Lille, France, 59000
    • Hopital Saint Vincent de Paul
  • Limoges, France, 87042
    • Hopital Uni Ire Dupuytren
  • Lyon, France, 69008
    • Centre Léon Bérard
  • Montpellier, France, 34295
    • CHU Montpellier - Saint Eloi
  • Nantes, France, 44093
    • CHU de Nantes - Hôtel Dieu
  • Nice, France, 06189
    • Centre Antoine Lacassagne
  • Nîmes, France, 30029
    • CHU de Nîmes - Hôpital Carémeau
  • Paris, France, 75475
    • Hopital Saint-Louis
  • Paris, France, 75743
    • Gh Necker Enfants Malades
  • Perpignan, France, 66046
    • Hopital Saint Jean
  • Pessac, France, 33604
    • Hopital Haut-Leveque - Centre Francois Magendie
  • Pierre-Bénite, France, 69310
    • CHU Lyon Sud - Service Hématologie
  • Poitiers, France, 86021
    • CHU De Poitiers
  • Quimper, France, 29107
    • Centre Hospitalier de Quimper Cornouaille (CHIC)
  • Rennes, France, 35033
    • Hopital Pontchaillou
  • Rouen, France, 76038
    • Centre Henri Becquerel
  • Saint-Brieuc, France, 22027
    • Centre Hospitalier de Saint Brieuc - Hôpital Yves Le Foll
  • Saint-Priest-en-Jarez, France, 42270
    • Pôle de Cancérologie ? CHU de Saint?Etienne'
  • Strasbourg, France, 67091
    • CHRU de Strasbourg
  • Toulouse, France, 31059
    • Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)
  • Tours, France, 37044
    • Chu Bretonneau
  • Vandœuvre-lès-Nancy, France, 54511
    • CHU de Brabois
  • Vannes, France, 56017
    • CH Bretagne Atlantique
  • Villejuif, France, 94805
    • Institut Gustave Roussy
• Germany
  • Berlin, Germany, 10967
    • Vivantes Klinikum Am Urban
  • Dessau, Germany, 06847
    • Städtisches Klinikum Dessau
  • Essen, Germany, 45147
    • Universitatsklinikum Essen
  • Halle, Germany, 6097
    • Universitatsklinikum Halle (Saale)
  • Heidelberg, Germany, 69120
    • Universitaetsklinikum Heidelberg
  • Koblenz, Germany, 56068
    • InVO - Institut für Versorgungsforschung in der Onkologie GbR
  • Münster, Germany, 48149
    • Universitatsklinikum Munster
• Italy
  • Abruzzo
    • Bergamo, Abruzzo, Italy, 24127
      • Asst Papa Giovanni XXIII
    • Brescia, Abruzzo, Italy, 25123
      • Asst Degli Spedali Civili Di Brescia
    • Rome, Abruzzo, Italy, DUMMY_VALUE
      • Universita degli Studi di Roma ''La Sapienza" - Clinica Ematologica
  • Emilia-Romagna
    • Reggio Emilia, Emilia-Romagna, Italy, DUMMY_VALUE
      • AUSL di Reggio Emilia, IRCCS, P.O. Arcispedale Santa Maria Nuova
  • Liguria
    • Genoa, Liguria, Italy, 16132
      • IRCCS AOU San Martino - IST
  • Lombardy
    • Monza, Lombardy, Italy, 20052
      • Istituto Nazionale dei Tumori
  • Piedmont
    • Novara, Piedmont, Italy, 28100
      • Azienda Ospedaliero Universitaria Maggiore della Carita di Novara
    • Turin, Piedmont, Italy, 10126
      • Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino
• Japan
  • Aichi, Japan, 464-8681
    • Aichi Cancer Center
  • Chiba, Japan, 260-8717
    • Chiba Cancer Center
  • Chiba, Japan, 277-8577
    • National Cancer Center Hospital East
  • Chūōku, Japan, 260-8670
    • Chiba University Hospital
  • Fukuoka, Japan, 811-1395
    • National Hospital Organization Kyushu Cancer Center
  • Fukuoka, Japan, 812-8582
    • Kyushu University Hospital
  • Hiroshima, Japan, 734-8551
    • Hiroshima University Hospital
  • Hokkaido, Japan, 060-8648
    • Hokkaido University Hospital
  • Hyōgo, Japan, 650-0047
    • Kobe City Medical Center General Hospital
  • Isehara-shi, Japan, 259-1193
    • Tokai University Hospital
  • Kumamoto, Japan, 860-8556
    • Kumamoto University Hospital
  • Kyoto, Japan, 602-8566
    • University Hospital Kyoto Prefectural University of Medicine
  • Miyagi, Japan, 980-8574
    • Tohoku University Hospital
  • Osaka, Japan, 589-8511
    • Kindai University Hospital
  • Osaka, Japan, 545-8586
    • Osaka Metropolitan University Hospital
  • Osaka, Japan, 565-0871
    • The University of Osaka Hospital
  • Tochigi, Japan, 329-0498
    • Jichi Medical University Hospital
  • Tokyo, Japan, 104-0045
    • National Cancer Center Hospital
  • Tokyo, Japan, 135-8550
    • The Cancer Institute Hospital of JFCR
• New Zealand
  • Auckland, New Zealand, 1023
    • Auckland City Hospital, Cancer and Blood Research
  • Christchurch, New Zealand, 8011
    • Canterbury Health Laboratories
  • WKO
    • Hamilton, WKO, New Zealand, 3204
      • Cancer Trials New Zealand
• Poland
  • Chorzów, Poland, 41-500
    • Samodzielny Publiczny Zak?ad Opieki Zdrowotnej Zespó? Szpitali Miejskich w Chorzowie
  • Krakow, Poland, 30-727
    • Pratia Ma?opolskie Centrum Medyczne (MCM) Kraków
  • Lodz, Poland, 93-510
    • Uniwersytet Medyczny w Lodzi
  • Późna, Poland, 60-631
    • SPZOZ Ministerstwa Spraw Wewn?trznych i Administracji w Poznaniu
  • Warsaw, Poland, 04-359
    • Wojskowy Instytut Medyczny Centralny Szpital Kliniczny MON
• Russia
  • Sankt-Peterburg
    • Saint Petersburg, Sankt-Peterburg, Russia, 194291
      • Leningrad Regional Clinical Hospital
• South Korea
  • Busan, South Korea, 49241
    • Pusan National University Hospital
  • Gyeonggi-do, South Korea, 410-769
    • National Cancer Center
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Seoul, South Korea, 06351
    • Samsung Medical Center
  • Seoul, South Korea, 03722
    • Severance Hospital
  • Yangsan, South Korea, 50612
    • Pusan National University Yangsan Hospital
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron
  • Barcelona, Spain, 08041
    • Hospital De La Santa Creu I Sant Pau
  • Barcelona, Spain, 08036
    • Hospital Clinic Barcelona
  • Cáceres, Spain, 10003
    • Hospital San Pedro de Alcántara
  • Girona, Spain, 17007
    • Hospital Universitari Dr. Josep Trueta
  • Madrid, Spain, 28040
    • Fundacion Jimenez Diaz
  • Madrid, Spain, 280146
    • Hospital Universitario La Paz
  • Madrid, Spain, 28233
    • Hospital Quiron Madrid
  • Málaga, Spain, 29010
    • Hospital Universitario Virgen de la Victoria
  • Seville, Spain, 41013
    • Hospital Universitario Virgen del Rocio
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08908
      • Institut Catala d Oncologia Hospitalet
  • Navarre
    • Pamplona, Navarre, Spain, 31008
      • Complejo Hospitalario de Navarra
• Switzerland
  • Basel, Switzerland, 4031
    • Universitatsspital Basel
• Taiwan
  • Kaohsiung City, Taiwan, 807
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Taichung, Taiwan, 40447
    • China Medical University Hospital
  • Tainan, Taiwan, 736
    • Chi-Mei Hospital, Liouying
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
  • Taipei, Taiwan, 11211
    • Taipei Veterans General Hospital
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06700
    • Ankara University Faculty of Medicine Cebeci Hospital
  • Balçova, Turkey (Türkiye), 35330
    • Dokuz Eylul Universitesi Tip Fakultesi
  • Lzmir, Turkey (Türkiye), 35100
    • Ege Universitesi Tip Fakultesi
• Ukraine
  • Chernihiv Governorate
    • Cherkassy, Chernihiv Governorate, Ukraine, DUMMY_VALUE
      • Communal Institution 'Cherkassy Regional Oncology Dispensary' of the Cherkassy Regional Council
    • Lviv, Chernihiv Governorate, Ukraine, 79007
      • MNE Lviv Territorial Medical Association Clinical Hospital for Palliative Care
  • Kharkiv Governorate
    • Khmelnytskyi, Kharkiv Governorate, Ukraine, 29000
      • Khmelnytskyi Regional Hospital
• United Kingdom
  • Cambridge, United Kingdom, CB2 0QQ
    • Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital
  • Canterbury, United Kingdom, CT1 3NG
    • East Kent Hospitals University NHS Foundation Trust
  • Leicester, United Kingdom, LE1 5WW
    • University Hospitals of Leicester NHS Trust - Leicester Royal Infirmary
  • London, United Kingdom, EC1M 6BQ
    • Barts Health NHS Trust - St Bartholomew's Hospital
  • Manchester, United Kingdom, M20 4BX
    • The Christie NHS Foundation Trust
  • Newcastle upon Tyne, United Kingdom, NE7 7DN
    • Freeman Hospital
  • Nottingham, United Kingdom, NG5 1PB
    • Nottingham University Hospitals NHS Trust - City Hospital
  • Oxford, United Kingdom, OX3 7LE
    • Oxford University Hospitals NHS Foundation Trust
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
    • Daphne, Alabama, United States, 36526
      • Southern Cancer Center
  • California
    • Duarte, California, United States, 91010
      • City of Hope
    • Los Angeles, California, United States, 90024-6997
      • Ronald Reagan UCLA Medical Center
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Rocky Mountain Cancer Centers, LLP
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20007
      • Georgetown University Medical Center
  • Florida
    • Fort Myers, Florida, United States, 33901-8101
      • Florida Cancer Specialists - Fort Myers (New Hampshire Ct)
    • St. Petersburg, Florida, United States, 33705
      • Florida Cancer Specialists & Research Institute
    • St. Petersburg, Florida, United States, 33705-1455
      • Florida Cancer Specialists & Research Institute
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
  • Illinois
    • Arlington Heights, Illinois, United States, 60005
      • Illinois Cancer Specialists
  • Kentucky
    • Louisville, Kentucky, United States, 40202-3229
      • James Graham Brown Cancer Center
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland
    • Baltimore, Maryland, United States, 21205
      • The Johns Hopkins Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02115
      • Dana Farber Cancer Institute
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Health System
    • Detroit, Michigan, United States, 48201
      • Karmanos Cancer Center
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute
    • Harrison, New York, United States, 10604-3200
      • Memorial Sloan Kettering Cancer Center at Westchester
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States, 10016
      • New York University Cancer Cen
    • New York, New York, United States, 10087-9049
      • Memorial Sloan Kettering Cancer Center - Commack
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514-4221
      • University of North Carolina School of Medicine
    • Charlotte, North Carolina, United States, 28204
      • Levine Cancer Institute - Clincal Trials Administration
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Oncology Hematology Care
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Case Medical Center
    • Cleveland, Ohio, United States, 44106
      • The Ohio State University Comprehensive Cancer Center
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Oncology Associates of Oregon, P.C
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
    • Portland, Oregon, United States, 97225
      • Northwest Cancer Specialists - Portland (SW Barnes Rd)
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232-1309
      • University of Pittsburgh Cancer Institute
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina (MUSC)
    • Greenville, South Carolina, United States, 29615
      • Prisma Health ? Upstate
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Greco-Hainesworth Centers for Research
    • Nashville, Tennessee, United States, 37203-1625
      • Tennessee Oncology
  • Texas
    • Austin, Texas, United States, 78705
      • Texas Oncology-Austin Midtown
    • San Antonio, Texas, United States, 78229
      • Texas Oncology San Antonio Medical Center
    • Tyler, Texas, United States, 75702
      • Texas Oncology-Tyler
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • University of Utah
  • Virginia
    • Blacksburg, Virginia, United States, 24060
      • Oncology Associates of Southwest Virginia, Inc.
    • Fairfax, Virginia, United States, 22031-4618
      • Virginia Cancer Specialists, PC
  • Washington
    • Seattle, Washington, United States, 98109
      • Seattle Cancer Care Alliance
  • West Virginia
    • Morgantown, West Virginia, United States, 26505
      • West Virginia Uni Med. Center - Robert Byrd Health Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Previously untreated participants with cluster of differentiation 20 (CD20)-positive DLBCL, including one of the following diagnoses by 2016 World Health Organization (WHO) classification of lymphoid neoplasms: DLBCL, not otherwise specified (NOS) including germinal center B-cell type, activated B-cell type; T-cell/histiocyte-rich large B-cell lymphoma; Epstein-Barr virus-positive DLBCL, NOS; anaplastic lymphoma kinase (ALK)-positive large B-cell lymphoma; human herpesvirus-8 (HHV8)-positive DLBCL, NOS; High-grade B-cell lymphoma with MYC and B-cell lymphoma 2 (BCL2) and/or B-cell lymphoma 6 (BCL6) rearrangements (double-hit or triple-hit lymphoma); High-grade B-cell lymphoma, NOS
• Availability of archival or freshly collected tumor tissue before study enrolment
• International Prognostic Index (IPI) score of 2-5
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
• Life expectancy greater than or equal to (>/=)12 months
• Left ventricular ejection fraction (LVEF) >/= 50 percent (%) on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO)
• Adequate hematologic function
• Female participants: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods and refrain from donating eggs.
• Male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom and agreement to refrain from donating sperm.

Exclusion Criteria:

• History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
• Contraindication to any of the individual components of CHOP, including prior receipt of anthracyclines
• Prior organ transplantation
• Current Grade greater than (>) 1 peripheral neuropathy by clinical examination
• Demyelinating form of Charcot-Marie-Tooth disease
• History of indolent lymphoma
• History of follicular lymphoma grade 3B
• B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma (grey-zone lymphoma)
• Primary mediastinal (thymic) large B-cell lymphoma
• Burkitt lymphoma
• Prior treatment with cytotoxic drugs within 5 years of screening for any condition (example [e.g.], cancer, rheumatoid arthritis) or prior use of any anti-CD20 antibody
• Prior use of any monoclonal antibody within 3 months of the start of Cycle 1
• Prior therapy for DLBCL, with the exception of nodal biopsy
• Corticosteroid use >30 mg/day of prednisone or equivalent, for purposes other than lymphoma symptom control
• Participants with central nervous system (CNS) lymphoma (primary or secondary involvement), primary effusion DLBCL, and primary cutaneous DLBCL
• Vaccination with live vaccines within 28 days prior to the start of Cycle 1
• Any investigational therapy within 28 days prior to the start of Cycle 1
• History of other malignancy that could affect compliance with the protocol or interpretation of results
• Evidence of significant, uncontrolled, concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease or pulmonary disease
• Recent major surgery (within 4 weeks prior to the start of Cycle 1), other than for diagnosis
• History or presence of an abnormal electrocardiogram (ECG) that is clinically significant in the investigator's opinion, including complete left bundle branch block, second- or third-degree heart block, or evidence of prior myocardial infarction
• Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or significant infections within 2 weeks before the start of Cycle 1
• Clinically significant liver disease, including active viral or other hepatitis, current alcohol abuse, or cirrhosis
• Prior radiotherapy to the mediastinal/pericardial region
• Participants with suspected active or latent tuberculosis
• Positive test results for chronic hepatitis B and hepatitis C infection
• Known history of human immunodeficiency virus (HIV) seropositive status
• Positive results for the human T-lymphotrophic 1 virus (HTLV-1)
• Participants with a history of progressive multifocal leukoencephalopathy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: R-CHP plus Vincristine Placebo plus Polatuzumab Vedotin; Participants will receive polatuzumab vedotin 1.8 milligrams per kilogram (mg/kg) intravenously (IV), placebo for vincristine IV, rituximab 375 milligrams per square meter (mg/m^2) IV, cyclophosphamide 750 mg/m^2 IV, and doxorubicin 50 mg/m^2 IV on Day 1 and prednisone 100 milligrams per day (mg/day) orally (PO) on Days 1-5 of every 21-day cycle for 6 cycles. Rituximab 375 mg/m^2 IV will be administered as monotherapy in Cycles 7 and 8.	Drug: Polatuzumab Vedotin; Polatuzumab vedotin IV infusion will be administered as per the schedule specified in the respective arm.; Other Names: DCDS4501A; anti-CD79b-VC-MMAE; 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 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.
Placebo Comparator: R-CHOP plus Polatuzumab Vedotin Placebo; Participants will receive placebo for polatuzumab vedotin, rituximab 375 mg/m^2 IV, cyclophosphamide 750 mg/m^2 IV, doxorubicin 50 mg/m^2 IV, and vincristine 1.4 mg/m^2 IV (maximum 2 milligrams per dose [mg/dose]) on Day 1 and prednisone 100 mg/day PO on Days 1-5 of every 21-day cycle for 6 cycles. Rituximab 375 mg/m^2 IV will be administered as monotherapy in Cycles 7 and 8.	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: Prednisone; Prednisone PO 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: Polatuzumab vedotin Placebo; Placebo matching to polatuzumab vedotin will be administered as per the schedule specified in the respective arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression-Free Survival (PFS) as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma	From randomization to the first occurrence of disease progression or relapse, or death from any cause, whichever occurs earlier (up to 38 months)

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants With Complete Response (CR) as Assessed by Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) by Blinded Independent Central Review (BICR)	End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 8 [Cycle length=21 days] [up to Week 32])
Event-Free Survival-Efficacy (EFSeff) as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma	From randomization to first occurrence of disease progression/relapse;or death from any cause;or other primary efficacy reason that leads to initiation of any non-protocol specified antilymphoma treatment(NALT);or residual disease(up to approx 65 months)
Percentage of Participants Who are Progression Free as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma	24 months after enrollment (up to approximately 65 months)
Overall Survival	From randomization until death from any cause (up to approximately 65 months)
Percentage of Participants With CR as Assessed by FDG-PET by Investigator	End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 8 [Cycle length=21 days] [up to Week 32])
Disease-Free Survival (DFS) as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma	From the date of first occurrence of a documented CR to the date of relapse or death from any cause (up to approximately 65 months)
Duration of Response as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma	From the date of first occurrence of a documented CR or partial response (PR) to the date of progression, relapse, or death from any cause (up to approximately 65 months)
Event-Free Survival-All Causes (EFSall) as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma	From randomization to disease progression or relapse, or death from any cause, or initiation of any NALT (up to approximately 65 months)
Time to Deterioration in European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30) Physical Functioning and Fatigue	Day 1 of Cycles 1, 2, 3 and 5 (Cycle length=21 days); treatment completion visit (TCV)/early treatment termination visit (ETTV) (up to approximately 32 weeks); post-treatment follow-up (FU) visit (up to approximately 65 months)
Time to Deterioration in Functional Assessment of Cancer Therapy-Lymphoma Lymphoma Subscale (FACT-Lym LymS)	Day 1 of Cycles 1, 2, 3 and 5 (Cycle length=21 days); TCV/ETTV (up to approximately 32 weeks); post-treatment FU visit (up to approximately 65 months)
Percentage of Participants Achieving Meaningful Improvement in EORTC QLQ-C30 Physical Functioning and Fatigue	Day 1 of Cycles 1, 2, 3 and 5 (Cycle length=21 days); TCV/ETTV (up to approximately 32 weeks); post-treatment FU visit (up to approximately 65 months)
Percentage of Participants Achieving Meaningful Improvement in FACT-Lym LymS	Day 1 of Cycles 1, 2, 3 and 5 (Cycle length=21 days); TCV/ETTV (up to approximately 32 weeks); post-treatment FU visit (up to approximately 65 months)
EORTC QLQ-C30 Treatment-Related Symptoms Score	Day 1 of Cycles 1, 2, 3 and 5 (Cycle length=21 days); TCV/ETTV (up to approximately 32 weeks); post-treatment FU visit (up to approximately 65 months)
Functional Assessment of Cancer Treatment/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) Peripheral Neuropathy Score	Day 1 of Cycles 1-8 (Cycle length=21 days); TCV/ETTV (up to approximately 32 weeks); post-treatment FU visit (up to approximately 65 months)
Percentage of Participants With adverse Events (AEs)	From randomization to the end of study (up to approximately 65 months)
Serum Concentration of Total Polatuzumab Vedotin	Pre-infusion (0 hour [hr]), 0.5 hr post-infusion (infusion duration=90 minutes [min]) on Day 1 of Cycle 1 and 4 (Cycle length=21 days); TCV/ETTV (up to approximately 32 weeks); post-treatment FU visit (up to approximately 65 months)
Plasma Concentration of Polatuzumab Vedotin Conjugate (Antibody-Conjugated Mono-Methyl Auristatin E [acMMAE])	0.5 hr post-infusion (infusion duration=90 min) on Day 1 of Cycle 1 and 4 (Cycle length=21 days); TCV/ETTV (up to approximately 32 weeks); post-treatment FU visit (up to approximately 65 months)
Plasma Concentration of Polatuzumab Vedotin Unconjugated MMAE	0.5 hr post-infusion (infusion duration=90 min) on Day 1 of Cycle 1 and 4 (Cycle length=21 days); TCV/ETTV (up to approximately 32 weeks); post-treatment FU visit (up to approximately 65 months)
Percentage of Participants With Anti-Drug Antibody (ADA) to Polatuzumab Vedotin	Pre-infusion (0 hr) on Day 1 of Cycle 1 and 4 (Cycle length=21 days); TCV/ETTV (up to approximately 32 weeks); post-treatment FU visit (up to approximately 65 months)

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

General Publications

• Varma G, Wang J, Diefenbach C. Polatuzumab vedotin in relapsed / refractory aggressive B-cell lymphoma. Expert Rev Anticancer Ther. 2022 Aug;22(8):795-803. doi: 10.1080/14737140.2022.2093191. Epub 2022 Jun 27.
• Tilly H, Morschhauser F, Sehn LH, Friedberg JW, Trneny M, Sharman JP, Herbaux C, Burke JM, Matasar M, Rai S, Izutsu K, Mehta-Shah N, Oberic L, Chauchet A, Jurczak W, Song Y, Greil R, Mykhalska L, Bergua-Burgues JM, Cheung MC, Pinto A, Shin HJ, Hapgood G, Munhoz E, Abrisqueta P, Gau JP, Hirata J, Jiang Y, Yan M, Lee C, Flowers CR, Salles G. Polatuzumab Vedotin in Previously Untreated Diffuse Large B-Cell Lymphoma. N Engl J Med. 2022 Jan 27;386(4):351-363. doi: 10.1056/NEJMoa2115304. Epub 2021 Dec 14.
• Hu B, Reagan PM, Sehn LH, Sharman JP, Hertzberg M, Zhang H, Kim A, Herbaux C, Molina L, Maruyama D, Stenner F, Chohan S, Kothari R, Lee Batlevi C, Hirata J, Sahin D, Lee C, Sugidono M, Tilly H. Subgroup analysis of older patients >/=60 years with diffuse large B-cell lymphoma in the phase 3 POLARIX study. Blood Adv. 2025 May 27;9(10):2489-2499. doi: 10.1182/bloodadvances.2024014707.
• Liao MZ, Deng R, Gibiansky L, Lu T, Agarwal P, Dere R, Lee C, Hirata J, Herbaux C, Salles G, Li C, Miles D. Ethnic sensitivity assessment: Polatuzumab vedotin pharmacokinetics in Asian and non-Asian patients with previously untreated diffuse large B-cell lymphoma in POLARIX. Clin Transl Sci. 2023 Dec;16(12):2744-2755. doi: 10.1111/cts.13669. Epub 2023 Oct 31.
• Song Y, Tilly H, Rai S, Zhang H, Jin J, Goto H, Terui Y, Shin HJ, Kim WS, Cao J, Feng J, Eom HS, Kim TM, Tsai XC, Gau JP, Koh H, Zhang L, Song Y, Yang Y, Li W, Huang H, Ando K, Sharman JP, Sehn LH, Bu L, Wang X, Jiang Y, Hirata J, Lee C, Zhu J, Izutsu K. Polatuzumab vedotin in previously untreated DLBCL: an Asia subpopulation analysis from the phase 3 POLARIX trial. Blood. 2023 Apr 20;141(16):1971-1981. doi: 10.1182/blood.2022017734.
• Morschhauser F, Salles G, Sehn LH, Herrera AF, Friedberg JW, Trneny M, Lenz G, Sharman JP, Herbaux C, Burke JM, Matasar M, Collins GP, Mehta-Shah N, Oberic L, Chauchet A, Jurczak W, Song Y, Pinto A, Rai S, Izutsu K, Greil R, Mykhalska L, Bergua-Burgues JM, Cheung MC, Shin HJ, Hapgood G, Munhoz E, Abrisqueta P, Gau JP, Jiang Y, McCall B, Chohan S, Sugidono M, Yan M, Batlevi CL, Tilly H, Flowers CR. Five-Year Outcomes of the POLARIX Study Comparing Pola-R-CHP and R-CHOP in Patients With Diffuse Large B-Cell Lymphoma. J Clin Oncol. 2025 Dec 10;43(35):3698-3705. doi: 10.1200/JCO-25-00925. Epub 2025 Sep 24.
• Thompson C, Trneny M, Morschhauser F, Salles G, Reagan PM, Hertzberg M, Zhang H, Thieblemont C, Hu B, Fonseca G, Kim WS, Martelli M, Mehta A, Singh A, Yan M, Hirata J, Sugidono M, Lee C, Sharman JP, Mehta-Shah N, Flowers CR, Tilly H, Chua N, Casasnovas RO, Miall F, Kim TM, Tsai XC, Nasta S, Lee ST, Friedberg JW. PROs vs clinician-reported adverse events in a large clinical trial: findings from the phase 3 POLARIX study. Blood. 2026 Jan 15;147(3):254-265. doi: 10.1182/blood.2025028848.

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2017
• Primary Completion (Actual): April 30, 2026
• Study Completion (Actual): April 30, 2026

Study Registration Dates

• First Submitted: September 5, 2017
• First Submitted That Met QC Criteria: September 5, 2017
• First Posted (Actual): September 7, 2017

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma; Hemic and Lymphatic Diseases; Lymphoma, Large B-Cell, Diffuse; Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hydrocarbons; Hydrocarbons, Cyclic; Carbohydrates; Alkaloids; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Glycosides; Indoles; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Pregnadienediols; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Indolizidines; Indolizines; Anthracyclines; Naphthacenes; Aminoglycosides; Antibodies, Monoclonal, Murine-Derived; Daunorubicin; Rituximab; Prednisone; Cyclophosphamide; Doxorubicin; Vincristine; polatuzumab vedotin
• Other Study ID Numbers: GO39942; 2017-002023-21 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No