AzTrials
AzTrials

Diffuse Large B-Cell LymphomaPhase 3POLARIXNCT03274492

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

A Phase 3 study testing Polatuzumab Vedotin, Rituximab and Cyclophosphamide in people with Diffuse Large B-Cell Lymphoma, run by Hoffmann-La Roche at 209 sites in 22 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Diffuse Large B-Cell Lymphoma
What is being tested?
Polatuzumab Vedotin, Rituximab and Cyclophosphamide
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,000 participants
Where
209 sitesin 22 countries
Study dates
16 Nov 2017to 30 Apr 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 9Show fewer
  • 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.

Who cannot join

  • 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
Show all 29Show fewer
  • 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

Trial locations and contacts

209 sites in 22 countries.

209 sites in 22 countries

United States49 sites

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109

  • Illinois Cancer Specialists

    Arlington Heights, Illinois, 60005

  • Emory University

    Atlanta, Georgia, 30322

  • Rocky Mountain Cancer Centers, LLP

    Aurora, Colorado, 80012

  • Texas Oncology-Austin Midtown

    Austin, Texas, 78705

  • University of Maryland

    Baltimore, Maryland, 21201

  • The Johns Hopkins Hospital

    Baltimore, Maryland, 21205

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Oncology Associates of Southwest Virginia, Inc.

    Blacksburg, Virginia, 24060

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • University of North Carolina School of Medicine

    Chapel Hill, North Carolina, 27514-4221

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina, 29425

  • Levine Cancer Institute - Clincal Trials Administration

    Charlotte, North Carolina, 28204

  • Greco-Hainesworth Centers for Research

    Chattanooga, Tennessee, 37403

  • Oncology Hematology Care

    Cincinnati, Ohio, 45242

  • The Ohio State University Comprehensive Cancer Center

    Cleveland, Ohio, 44106

  • University Hospitals Case Medical Center

    Cleveland, Ohio, 44106

  • Southern Cancer Center

    Daphne, Alabama, 36526

  • Karmanos Cancer Center

    Detroit, Michigan, 48201

  • City of Hope

    Duarte, California, 91010

  • Oncology Associates of Oregon, P.C

    Eugene, Oregon, 97401

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031-4618

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

    Fort Myers, Florida, 33901-8101

  • Prisma Health ? Upstate

    Greenville, South Carolina, 29615

  • Memorial Sloan Kettering Cancer Center at Westchester

    Harrison, New York, 10604-3200

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California, 90024-6997

  • James Graham Brown Cancer Center

    Louisville, Kentucky, 40202-3229

  • West Virginia Uni Med. Center - Robert Byrd Health Science

    Morgantown, West Virginia, 26505

  • Tennessee Oncology

    Nashville, Tennessee, 37203-1625

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121

  • New York University Cancer Cen

    New York, New York, 10016

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Memorial Sloan Kettering Cancer Center - Commack

    New York, New York, 10087-9049

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15232-1309

  • Northwest Cancer Specialists - Portland (SW Barnes Rd)

    Portland, Oregon, 97225

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • University of Utah

    Salt Lake City, Utah, 84112

  • Texas Oncology San Antonio Medical Center

    San Antonio, Texas, 78229

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • Washington University

    St Louis, Missouri, 63110

  • Florida Cancer Specialists & Research Institute

    St. Petersburg, Florida, 33705-1455

  • Florida Cancer Specialists & Research Institute

    St. Petersburg, Florida, 33705

  • Texas Oncology-Tyler

    Tyler, Texas, 75702

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

Other trials in United States

France37 sites

  • CHU Amiens - Hopital Sud

    Amiens, 80054

  • CHU Angers

    Angers, 49933

  • Centre Hospitalier de La Cote Basque

    Bayonne, 64109

  • Institut Bergonie

    Bordeaux, 33076

  • Institut d'Hématologie de Basse Normandie

    Caen, 14000

  • CH Metropole de Savoie

    Chambéry, 73011

  • Hopital Henri Mondor

    Créteil, 94010

  • CHU de Dijon - Hopital le Bocage

    Dijon, 21000

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

    Grenoble, 38000

  • CHD Vendée

    La Roche-sur-Yon, 85025

  • Hôpital Albert Michallon

    La Tronche, 38700

  • Clinique Victor Hugo - Centre Jean Bernard

    Le Mans, 72015

  • Hôpital Saint Vincent de Paul

    Lille, 59000

  • Hopital Claude Huriez

    Lille, 59037

  • Hopital Uni Ire Dupuytren

    Limoges, 87042

  • Centre Leon Berard

    Lyon, 69008

  • CHU Montpellier - Saint ELOI

    Montpellier, 34295

  • CHU de Nantes - Hotel Dieu

    Nantes, 44093

  • Centre Antoine Lacassagne

    Nice, 06189

  • CHU de Nîmes - Hôpital Carémeau

    Nîmes, 30029

  • Hôpital Saint-Louis

    Paris, 75475

  • Gh Necker Enfants Malades

    Paris, 75743

  • Hopital Saint Jean

    Perpignan, 66046

  • Hopital Haut-Leveque - Centre Francois Magendie

    Pessac, 33604

  • CHU Lyon Sud - Service Hématologie

    Pierre-Bénite, 69310

  • CHU de Poitiers

    Poitiers, 86021

  • Centre Hospitalier de Quimper Cornouaille (CHIC)

    Quimper, 29107

  • Hopital Pontchaillou

    Rennes, 35033

  • Centre Henri Becquerel

    Rouen, 76038

  • Centre Hospitalier de Saint Brieuc - Hôpital Yves Le Foll

    Saint-Brieuc, 22027

  • Pôle de Cancérologie ? CHU de Saint?Etienne'

    Saint-Priest-en-Jarez, 42270

  • Chru de Strasbourg

    Strasbourg, 67091

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

    Toulouse, 31059

  • CHU Bretonneau

    Tours, 37044

  • CHU de Brabois

    Vandœuvre-lès-Nancy, 54511

  • CH Bretagne Atlantique

    Vannes, 56017

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Japan19 sites

  • Aichi Cancer Center

    Aichi, 464-8681

  • Chiba Cancer Center

    Chiba, 260-8717

  • National Cancer Center Hospital East

    Chiba, 277-8577

  • Chiba University Hospital

    Chūōku, 260-8670

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 811-1395

  • Kyushu University Hospital

    Fukuoka, 812-8582

  • Hiroshima University Hospital

    Hiroshima, 734-8551

  • Hokkaido University Hospital

    Hokkaido, 060-8648

  • Kobe City Medical Center General Hospital

    Hyōgo, 650-0047

  • Tokai University Hospital

    Isehara-shi, 259-1193

  • Kumamoto University Hospital

    Kumamoto, 860-8556

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, 602-8566

  • Tohoku University Hospital

    Miyagi, 980-8574

  • Osaka Metropolitan University Hospital

    Osaka, 545-8586

  • The University of Osaka Hospital

    Osaka, 565-0871

  • Kindai University Hospital

    Osaka, 589-8511

  • Jichi Medical University Hospital

    Tochigi, 329-0498

  • National Cancer Center Hospital

    Tokyo, 104-0045

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135-8550

Other trials in Japan

Spain12 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Clinic Barcelona

    Barcelona, 08036

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

  • Hospital San Pedro de Alcantara

    Cáceres, 10003

  • Hospital Universitari Dr. Josep Trueta

    Girona, 17007

  • Institut Catala d Oncologia Hospitalet

    L'Hospitalet de Llobregat, Barcelona, 08908

  • Hospital Universitario La Paz

    Madrid, 280146

  • Fundación Jimenez Díaz

    Madrid, 28040

  • Hospital Quiron Madrid

    Madrid, 28233

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010

  • Complejo Hospitalario de Navarra

    Pamplona, Navarre, 31008

  • Hospital Universitario Virgen del Rocío

    Seville, 41013

Other trials in Spain

Australia10 sites

  • Monash Medical Centre Clayton

    Clayton, Victoria, 3168

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • Austin Hospital

    Heidelberg, Victoria, 3084

  • St George Hospital

    Kogarah, New South Wales, 2217

  • Ashford Cancer Center Research

    Kurralta Park, South Australia, 5037

  • Prince of Wales Hospital

    Randwick, New South Wales, 2031

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298

  • Westmead Hospital

    Westmead, New South Wales, 2145

  • The University of Adelaide - The Queen Elizabeth Hospital (TQEH)

    Woodville South, South Australia, 5011

  • Princess Alexandra Hospital Woolloongabba

    Woolloongabba, Queensland, 4102

Other trials in Australia

China10 sites

  • Beijing Cancer Hospital

    Beijing, 100142

  • The First Hospital of Jilin University

    Changchun, 130021

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

    Hangzhou, 310003

  • Jiangsu Cancer Hospital

    Nanjing, 210009

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, 200025

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

  • Shanghai East Hospital, Tongji University

    Shanghai, 200120

  • Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

    Tianjin, 300020

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, 430022

  • Henan Cancer Hospital

    Zhengzhou, 450008

Other trials in China

Italy8 sites

  • Asst Papa Giovanni XXIII

    Bergamo, Abruzzo, 24127

  • Asst Degli Spedali Civili Di Brescia

    Brescia, Abruzzo, 25123

  • IRCCS AOU San Martino - IST

    Genoa, Liguria, 16132

  • Istituto Nazionale dei Tumori

    Monza, Lombardy, 20052

  • Azienda Ospedaliero Universitaria Maggiore della Carita di Novara

    Novara, Piedmont, 28100

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

    Reggio Emilia, Emilia-Romagna, DUMMY_VALUE

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

    Rome, Abruzzo, DUMMY_VALUE

  • Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino

    Turin, Piedmont, 10126

Other trials in Italy

United Kingdom8 sites

  • Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital

    Cambridge, CB2 0QQ

  • East Kent Hospitals University NHS Foundation Trust

    Canterbury, CT1 3NG

  • University Hospitals of Leicester NHS Trust - Leicester Royal Infirmary

    Leicester, LE1 5WW

  • Barts Health NHS Trust - St Bartholomew's Hospital

    London, EC1M 6BQ

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

  • Freeman Hospital

    Newcastle upon Tyne, NE7 7DN

  • Nottingham University Hospitals NHS Trust - City Hospital

    Nottingham, NG5 1PB

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, OX3 7LE

Other trials in United Kingdom

Canada7 sites

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

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

    Montreal, Quebec, H1T 2M4

  • The Ottawa Hospital

    Ottawa, Ontario, K1H 8L6

  • Hôpital de l'Enfant-Jésus

    Québec, Quebec, G1J 1Z4

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • BC Cancer Agency Vancouver Centre

    Vancouver, British Columbia, V5Z 4E6

  • CancerCare Manitoba (CCMB)

    Winnipeg, Manitoba, MB R3E 0V9

Other trials in Canada

Germany7 sites

  • Vivantes Klinikum Am Urban

    Berlin, 10967

  • Städtisches Klinikum Dessau

    Dessau, 06847

  • Universitätsklinikum Essen

    Essen, 45147

  • Universitätsklinikum Halle (Saale)

    Halle, 6097

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120

  • InVO - Institut für Versorgungsforschung in der Onkologie GbR

    Koblenz, 56068

  • Universitatsklinikum Munster

    Münster, 48149

Other trials in Germany

South Korea7 sites

  • Pusan National University Hospital

    Busan, 49241

  • National Cancer Center

    Gyeonggi-do, 410-769

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • Pusan National University Yangsan Hospital

    Yangsan, 50612

Other trials in South Korea

Poland5 sites

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

    Chorzów, 41-500

  • Pratia Ma?opolskie Centrum Medyczne (MCM) Kraków

    Krakow, 30-727

  • Uniwersytet Medyczny w Lodzi

    Lodz, 93-510

  • SPZOZ Ministerstwa Spraw Wewn?trznych i Administracji w Poznaniu

    Późna, 60-631

  • Wojskowy Instytut Medyczny Centralny Szpital Kliniczny MON

    Warsaw, 04-359

Other trials in Poland

Taiwan5 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

  • China Medical University Hospital

    Taichung, 40447

  • Chi-Mei Hospital, Liouying

    Tainan, 736

  • National Taiwan University Hospital

    Taipei, 10002

  • Taipei Veterans General Hospital

    Taipei, 11211

Other trials in Taiwan

Brazil4 sites

  • Centro de Hematologia e Hemoterapia - HEMOCENTRO UNICAMP

    Campinas, São Paulo, 13083-878

  • Hospital Erasto Gaertner

    Curitiba, Paraná, 81520-060

  • Hospital de Clínicas de Porto Alegre X

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Hospital das Clinicas - FMUSP

    São Paulo, São Paulo, 05403-000

Other trials in Brazil

Czechia4 sites

  • Fakultni Nemocnice Hradec Kralove (FNHK)

    Hradec Králové, 500 05

  • Fakultní nemocnice Olomouc

    Olomouc, 779 00

  • Fakultni Nemocnice Kralovske Vinohrady (FNKV)

    Prague, 100 34

  • Všeobecná fakultní nemocnice v Praze

    Prague, 128 08

Other trials in Czechia

Austria3 sites

  • Paracelsus Medizinischen Privatuniversitaet-Salzburger Landeskliniken (SALK)

    Salzburg, 5020

  • Medizinische Universität Wien

    Vienna, 1090

  • Wiener Gesundheitsverbund ? Klinik Ottakring

    Vienna, 1160

Other trials in Austria

Belgium3 sites

  • UZ Gent

    Ghent, 9000

  • CH Jolimont - Lobbes (Jolimont)

    Haine-Saint-Paul, 7100

  • CHU UCL Mont-Godinne

    Mont-godinne, 5530

Other trials in Belgium

New Zealand3 sites

  • Auckland City Hospital, Cancer and Blood Research

    Auckland, 1023

  • Canterbury Health Laboratories

    Christchurch, 8011

  • Cancer Trials New Zealand

    Hamilton, WKO, 3204

Other trials in New Zealand

Turkey (Türkiye)3 sites

  • Ankara University Faculty of Medicine Cebeci Hospital

    Ankara, 06700

  • Dokuz Eylul Universitesi Tip Fakultesi

    Balçova, 35330

  • Ege Üniversitesi Tip Fakültesi

    Lzmir, 35100

Other trials in Turkey (Türkiye)

Ukraine3 sites

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

    Cherkassy, Chernihiv Governorate, DUMMY_VALUE

  • Khmelnytskyi Regional Hospital

    Khmelnytskyi, Kharkiv Governorate, 29000

  • MNE Lviv Territorial Medical Association Clinical Hospital for Palliative Care

    Lviv, Chernihiv Governorate, 79007

Other trials in Ukraine

Russia1 site

  • Leningrad Regional Clinical Hospital

    Saint Petersburg, Sankt-Peterburg, 194291

Other trials in Russia

Switzerland1 site

  • Universitätsspital Basel

    Basel, 4031

Other trials in Switzerland

About this study

Official title: 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).

Being tested
Polatuzumab Vedotin, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Polatuzumab VedotinDrug

    Also called DCDS4501A; anti-CD79b-VC-MMAE

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

  • RituximabDrug

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

  • CyclophosphamideDrug

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

  • DoxorubicinDrug

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

  • VincristineDrug

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

  • Vincristine PlaceboDrug

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

  • PrednisoneDrug

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

  • Polatuzumab vedotin PlaceboDrug

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

Study groups in NCT03274492
Study groupRoleWhat they receive
R-CHP plus Vincristine Placebo plus Polatuzumab VedotinExperimentalParticipants 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.
Receives: Drug: Polatuzumab Vedotin; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine Placebo; Drug: Prednisone
R-CHOP plus Polatuzumab Vedotin PlaceboPlacebo comparatorParticipants 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.
Receives: Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone; Drug: Polatuzumab vedotin Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival (PFS) as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma

    Measured: From randomization to the first occurrence of disease progression or relapse, or death from any cause, whichever occurs earlier (up to 38 months)

Secondary outcomes (19)

  1. Percentage of Participants With Complete Response (CR) as Assessed by Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) by Blinded Independent Central Review (BICR)

    Measured: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 8 [Cycle length=21 days] [up to Week 32])

  2. Event-Free Survival-Efficacy (EFSeff) as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma

    Measured: 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)

  3. Percentage of Participants Who are Progression Free as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma

    Measured: 24 months after enrollment (up to approximately 65 months)

  4. Overall Survival

    Measured: From randomization until death from any cause (up to approximately 65 months)

  5. Percentage of Participants With CR as Assessed by FDG-PET by Investigator

    Measured: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 8 [Cycle length=21 days] [up to Week 32])

  6. Disease-Free Survival (DFS) as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma

    Measured: 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)

  7. Duration of Response as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma

    Measured: 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)

  8. Event-Free Survival-All Causes (EFSall) as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma

    Measured: From randomization to disease progression or relapse, or death from any cause, or initiation of any NALT (up to approximately 65 months)

  9. 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

    Measured: 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)

  10. Time to Deterioration in Functional Assessment of Cancer Therapy-Lymphoma Lymphoma Subscale (FACT-Lym LymS)

    Measured: 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)

  11. Percentage of Participants Achieving Meaningful Improvement in EORTC QLQ-C30 Physical Functioning and Fatigue

    Measured: 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)

  12. Percentage of Participants Achieving Meaningful Improvement in FACT-Lym LymS

    Measured: 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)

  13. EORTC QLQ-C30 Treatment-Related Symptoms Score

    Measured: 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)

  14. Functional Assessment of Cancer Treatment/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) Peripheral Neuropathy Score

    Measured: 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)

  15. Percentage of Participants With adverse Events (AEs)

    Measured: From randomization to the end of study (up to approximately 65 months)

  16. Serum Concentration of Total Polatuzumab Vedotin

    Measured: 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)

  17. Plasma Concentration of Polatuzumab Vedotin Conjugate (Antibody-Conjugated Mono-Methyl Auristatin E [acMMAE])

    Measured: 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)

  18. Plasma Concentration of Polatuzumab Vedotin Unconjugated MMAE

    Measured: 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)

  19. Percentage of Participants With Anti-Drug Antibody (ADA) to Polatuzumab Vedotin

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2017
  2. Study start16 Nov 2017
  3. Primary completion30 Apr 2026
  4. Study completion30 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03274492
Sponsor's protocol ID
GO39942
Other IDs
2017-002023-21, 2017
Acronym
POLARIX
Status last verified
May 2026
First submitted
5 Sep 2017
Last updated
8 May 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • Morschhauser F, Lenz G, Herrera AF, Flowers CR, Trneny M, Burke JM, Hou JZ, Staber PB, Hawkes EA, Izutsu K, Le Gouill S, Belada D, Tucci A, Yan M, Harris W, Lu K, Bolen CR, Hirata J, Lee C, Jiang Y, Jardin F, Hatzi K. Low lymphoma macrophage infiltration predicts poor outcomes for R-CHOP- but not Pola-R-CHP-treated patients with DLBCL. Blood Neoplasia. 2026 Jul 2;3(4):100264. doi: 10.1016/j.bneo.2026.100264. eCollection 2026 Nov.

    PubMed 42699559

  • 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.

    PubMed 40997297

  • 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.

    PubMed 40991874

  • 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.

    PubMed 40085955

  • 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.

    PubMed 37864313

  • 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.

    PubMed 36626583

  • 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.

    PubMed 35726803

  • 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.

    PubMed 34904799

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Polatuzumab Vedotin, Rituximab and Cyclophosphamide in people with Diffuse Large B-Cell Lymphoma, run by Hoffmann-La Roche at 209 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 209 sites in United States, France, Japan, Spain, Australia and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma (time frame: From randomization to the first occurrence of disease progression or relapse, or death from any cause, whichever occurs earlier (up to 38 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03274492, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in