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
2 other identifiers
interventional
1,000
21 countries
212
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2017
Longer than P75 for phase_3
212 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 5, 2017
CompletedFirst Posted
Study publicly available on registry
September 7, 2017
CompletedStudy Start
First participant enrolled
November 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2026
CompletedFebruary 6, 2026
February 1, 2026
8.5 years
September 5, 2017
February 5, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (19)
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])
- +14 more secondary outcomes
Study Arms (2)
R-CHP plus Vincristine Placebo plus Polatuzumab Vedotin
EXPERIMENTALParticipants 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.
R-CHOP plus Polatuzumab Vedotin Placebo
PLACEBO 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.
Interventions
Polatuzumab vedotin IV infusion will be administered as per the schedule specified in the respective arm.
Rituximab IV infusion will be administered as per the schedule specified in the respective arm.
Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.
Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.
Vincristine IV infusion will be administered as per the schedule specified in the respective arm.
Placebo matching to vincristine will be administered as per the schedule specified in the respective arm.
Prednisone PO will be administered as per the schedule specified in the respective arm.
Placebo matching to polatuzumab vedotin will be administered as per the schedule specified in the respective arm.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (215)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Southern Cancer Center
Daphne, Alabama, 36526, United States
City of Hope
Duarte, California, 91010, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095, United States
Rocky Mountain Cancer Centers, LLP
Aurora, Colorado, 80012, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
Florida Cancer Specialists - Fort Myers (New Hampshire Ct)
Fort Myers, Florida, 33901-8101, United States
Florida Cancer Specialists & Research Institute
St. Petersburg, Florida, 33705, United States
Florida Cancer Specialists
West Palm Beach, Florida, 33401, United States
Emory University
Atlanta, Georgia, 30322, United States
Illinois Cancer Specialists
Arlington Heights, Illinois, 60005, United States
University of Louisville Hospital
Louisville, Kentucky, 40202, United States
Ochsner Medical Center
New Orleans, Louisiana, 70121, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Johns Hopkins University
Baltimore, Maryland, 21287, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
Karmanos Cancer Center
Detroit, Michigan, 48201, United States
Washington University
St Louis, Missouri, 63110, United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Memorial Sloan Kettering Cancer Center - Commack
Commack, New York, 11725, United States
Memorial Sloan Kettering Cancer Center at Westchester
Harrison, New York, 10604, United States
New York University Cancer Cen
New York, New York, 10016, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
University of North Carolina School of Medicine
Chapel Hill, North Carolina, 27514-4221, United States
Levine Cancer Institute - Clincal Trials Administration
Charlotte, North Carolina, 28204, United States
Oncology/Hematology Care Clinical Trials LLC
Cincinnati, Ohio, 45236, United States
University Hospitals Case Medical Center
Cleveland, Ohio, 44106, United States
Ohio State University
Columbus, Ohio, 43210, United States
Oncology Associates of Oregon, P.C
Eugene, Oregon, 97401, United States
Northwest Cancer Specialists - Portland (SW Barnes Rd)
Portland, Oregon, 97225, United States
Oregon HSU
Portland, Oregon, 97239, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
University of Pittsburgh Medical Center Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
Medical University of South Carolina Hospital
Charleston, South Carolina, 29425, United States
Prisma Health ? Upstate
Greenville, South Carolina, 29615, United States
Greco-Hainesworth Centers for Research
Chattanooga, Tennessee, 37403, United States
Tennessee Oncology - Nashville
Nashville, Tennessee, 37203, United States
Texas Oncology-Austin Midtown
Austin, Texas, 78705, United States
Texas Oncology San Antonio Medical Center
San Antonio, Texas, 78229, United States
Texas Oncology-Tyler
Tyler, Texas, 75702, United States
University of Utah
Salt Lake City, Utah, 84112, United States
Oncology Associates of Southwest Virginia, Inc.
Blacksburg, Virginia, 24060, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98101, United States
West Virginia Uni Med. Center - Robert Byrd Health Science
Morgantown, West Virginia, 26506, United States
Concord Repatriation General Hospital
Concord, New South Wales, 2139, Australia
St George Hospital
Kogarah, New South Wales, 2217, Australia
Prince of Wales Hospital
Randwick, New South Wales, 2031, Australia
Calvary Mater Newcastle
Waratah, New South Wales, 2298, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Princess Alexandra Hospital Woolloongabba
Woolloongabba, Queensland, 4102, Australia
Ashford Cancer Center Research
Kurralta Park, South Australia, 5037, Australia
The University of Adelaide - The Queen Elizabeth Hospital (TQEH)
Woodville South, South Australia, 5011, Australia
Monash Medical Centre
Clayton, Victoria, 3168, Australia
Austin Hospital
Heidelberg, Victoria, 3084, Australia
Paracelsus Medizinischen Privatuniversitaet-Salzburger Landeskliniken (SALK)
Salzburg, 5020, Austria
Medizinische Universität Wien
Vienna, 1090, Austria
Wiener Gesundheitsverbund ? Klinik Ottakring
Vienna, 1160, Austria
UZ Gent
Ghent, 9000, Belgium
CH Jolimont - Lobbes (Jolimont)
Haine-Saint-Paul, 7100, Belgium
CHU UCL Mont-Godinne
Mont-godinne, 5530, Belgium
Hospital Erasto Gaertner
Curitiba, Paraná, 81520-060, Brazil
Hospital das Clinicas - UFRGS
Porto Alegre, Rio Grande do Sul, DUMMY_VALUE, Brazil
Centro de Hematologia e Hemoterapia - HEMOCENTRO UNICAMP
Campinas, São Paulo, 13083-878, Brazil
Hospital das Clinicas - FMUSP
São Paulo, São Paulo, 05403-000, Brazil
University of Alberta Hospital
Edmonton, Alberta, T6G 1Z2, Canada
BC Cancer ? Vancouver
Vancouver, British Columbia, V5Z 4E6, Canada
CancerCare Manitoba (CCMB)
Winnipeg, Manitoba, MB R3E 0V9, Canada
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
CIUSSS de l Est de l Ile de Montreal - Hopital Maisonneuve Rosemont
Montreal, Quebec, H1T 2M4, Canada
CHU de Quebec-Universite Laval
Québec, G1J 1Z4, Canada
Beijing Cancer Hospital
Beijing, 100142, China
The First Hospital of Jilin University
Changchun, 130021, China
Fujian Provincial Cancer Hospital
Fuzhou, 350014, China
Sun Yet-sen University Cancer Center
Guangzhou, 510060, China
The First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, 310003, China
Jiangsu Cancer Hospital
Nanjing, 210009, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, 200025, China
Fudan University Shanghai Cancer Center
Shanghai, 200032, China
Shanghai East Hospital, Tongji University
Shanghai, 200032, China
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
Tianjin, 300020, China
Tianjin Medical University Cancer Institute & Hospital
Tianjing, 300060, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, 430022, China
Henan Cancer Hospital
Zhengzhou, 450008, China
Fakultni Nemocnice Hradec Kralove (FNHK)
Hradec Králové, 500 05, Czechia
Fakultni nemocnice Olomouc
Olomouc, 775 20, Czechia
Fakultni nemocnice Ostrava
Ostrava - Poruba, 708 52, Czechia
Fakultni Nemocnice Kralovske Vinohrady (FNKV)
Prague, 100 34, Czechia
Všeobecná fakultní nemocnice v Praze
Prague, 128 08, Czechia
CHU Amiens - Hopital Sud
Amiens, 80054, France
CHU Angers
Angers, 49933, France
Centre Hospitalier de La Cote Basque
Bayonne, 64109, France
Hopital Jean Minjoz
Besançon, 25030, France
Institut Bergonie
Bordeaux, 33076, France
Institut d'Hématologie de Basse Normandie
Caen, 14000, France
CH Metropole de Savoie
Chambéry, 73011, France
Hopital Henri Mondor
Créteil, 94010, France
CHU de Dijon - Hopital le Bocage
Dijon, 21000, France
L'Union Mutualiste de la Gestion des Eaux Claires - Institut Daniel Hollard
Grenoble, 38000, France
CHD Vendée
La Roche-sur-Yon, 85025, France
Hôpital Albert Michallon
La Tronche, 38700, France
Clinique Victor Hugo - Centre Jean Bernard
Le Mans, 72015, France
Hôpital Saint Vincent de Paul
Lille, 59000, France
Hopital Claude Huriez
Lille, 59037, France
Hopital Uni Ire Dupuytren
Limoges, 87042, France
Centre Leon Berard
Lyon, 69008, France
CHU Montpellier - Saint ELOI
Montpellier, 34295, France
CHU de Nantes - Hotel Dieu
Nantes, 44093, France
Centre Antoine Lacassagne
Nice, 06189, France
CHU de Nîmes - Hôpital Carémeau
Nîmes, 30029, France
Hôpital Saint-Louis
Paris, 75475, France
Gh Necker Enfants Malades
Paris, 75743, France
Hopital Saint Jean
Perpignan, 66046, France
Hopital Haut-Leveque - Centre Francois Magendie
Pessac, 33604, France
CHU Lyon Sud - Service Hématologie
Pierre-Bénite, 69310, France
CHU de Poitiers
Poitiers, 86021, France
Centre Hospitalier de Quimper Cornouaille (CHIC)
Quimper, 29107, France
Hopital Pontchaillou
Rennes, 35033, France
Centre Henri Becquerel
Rouen, 76038, France
Centre Hospitalier de Saint Brieuc - Hôpital Yves Le Foll
Saint-Brieuc, 22027, France
Pôle de Cancérologie ? CHU de Saint?Etienne'
Saint-Priest-en-Jarez, 42270, France
Chru de Strasbourg
Strasbourg, 67091, France
Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)
Toulouse, 31059, France
CHU Bretonneau
Tours, 37044, France
CHU de Brabois
Vandœuvre-lès-Nancy, 54511, France
CH Bretagne Atlantique
Vannes, 56017, France
Institut Gustave Roussy
Villejuif, 94805, France
Vivantes Klinikum Am Urban
Berlin, 10967, Germany
Städtisches Klinikum Dessau
Dessau, 06847, Germany
Universitätsklinikum Essen
Essen, 45147, Germany
Universitaetsklinikum Halle (Saale)
Halle, 06120, Germany
Universitaetsklinikum Heidelberg
Heidelberg, 69120, Germany
InVO - Institut für Versorgungsforschung in der Onkologie GbR
Koblenz, 56068, Germany
Universitatsklinikum Munster
Münster, 48149, Germany
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, Abruzzo, 24060, Italy
Universita degli Studi Di Brescia - Azienda Ospedaliera Spedali Civili di Brescia
Brescia, Abruzzo, DUMMY_VALUE, Italy
Universita degli Studi di Roma ''La Sapienza" - Clinica Ematologica
Rome, Abruzzo, DUMMY_VALUE, Italy
AUSL di Reggio Emilia, IRCCS, P.O. Arcispedale Santa Maria Nuova
Reggio Emilia, Emilia-Romagna, DUMMY_VALUE, Italy
IRCCS AOU San Martino - IST
Genoa, Liguria, 16132, Italy
Istituto Nazionale dei Tumori
Monza, Lombardy, 20052, Italy
Azienda Ospedaliero Universitaria Maggiore della Carita di Novara
Novara, Piedmont, 28100, Italy
Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino
Turin, Piedmont, 00126, Italy
Aichi Cancer Center
Aichi, 464-8681, Japan
Chiba Cancer Center
Chiba, 260-8717, Japan
National Cancer Center Hospital East
Chiba, 277-8577, Japan
Chiba University Hospital
Chūōku, 260-8670, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395, Japan
Kyushu University Hospital
Fukuoka, 812-8582, Japan
Hiroshima University Hospital
Hiroshima, 734-8551, Japan
Hokkaido University Hospital
Hokkaido, 060-8648, Japan
Kobe City Medical Center General Hospital
Hyōgo, 650-0047, Japan
Tokai University Hospital
Isehara-shi, 259-1193, Japan
Kumamoto University Hospital
Kumamoto, 860-8556, Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto, 602-8566, Japan
Tohoku University Hospital
Miyagi, 980-8574, Japan
Osaka Metropolitan University Hospital
Osaka, 545-8586, Japan
The University of Osaka Hospital
Osaka, 565-0871, Japan
Kindai University Hospital
Osaka, 589-8511, Japan
Jichi Medical University Hospital
Tochigi, 329-0498, Japan
National Cancer Center Hospital
Tokyo, 104-0045, Japan
The Cancer Institute Hospital of JFCR
Tokyo, 135-8550, Japan
Auckland City Hospital, Cancer and Blood Research
Auckland, 1023, New Zealand
Canterbury Health Laboratories
Christchurch, 8011, New Zealand
Waikato Hospital
Hamilton, 3204, New Zealand
Samodzielny Publiczny Zak?ad Opieki Zdrowotnej Zespó? Szpitali Miejskich w Chorzowie
Chorzów, 41-500, Poland
PRATIA MCM Kraków
Krakow, 30-727, Poland
Uniwersytet Medyczny w Lodzi
Lodz, 93-510, Poland
SPZOZ Ministerstwa Spraw Wewn?trznych i Administracji w Poznaniu
Późna, 60-631, Poland
Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy
Warsaw, 04-141, Poland
Leningrad Regional Clinical Hospital
Saint Petersburg, Sankt-Peterburg, 194291, Russia
Pusan National University Hospital
Busan, 49241, South Korea
National Cancer Center
Gyeonggi-do, 410-769, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Pusan National University Yangsan Hospital
Yangsan, DUMMY_VALUE, South Korea
Complejo Hospitalario de Navarra
Pamplona, Navarre, 31008, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Clinic Barcelona
Barcelona, 08036, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041, Spain
Institut Catala d Oncologia Hospitalet
Barcelona, 08908, Spain
Hospital San Pedro de Alcantara
Cáceres, 10003, Spain
Hospital Universitari Dr. Josep Trueta
Girona, 17007, Spain
Hospital Universitario La Paz
Madrid, 280146, Spain
Fundación Jimenez Díaz
Madrid, 28040, Spain
Hospital Quiron Madrid
Madrid, 28233, Spain
Hospital Universitario Virgen de la Victoria
Málaga, 29010, Spain
Hospital Universitario Virgen del Rocío
Seville, 41013, Spain
Universitätsspital Basel Gynäkologie - Onkologie
Basel, 4031, Switzerland
Kaohsiung Medical University Hospital, Cancer Center
Kaohsiung City, 807, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
Chi-Mei Hospital, Liouying
Tainan, 736, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Taipei Veterans General Hospital
Taipei, 11211, Taiwan
Ankara University Faculty of Medicine Cebeci Hospital
Ankara, 06700, Turkey (Türkiye)
Ege Üniversitesi Tip Fakültesi
Lzmir, 35100, Turkey (Türkiye)
Dokuz Eylul Universitesi Tip Fakultesi
Lzmir, 35340, Turkey (Türkiye)
Communal Institution 'Cherkassy Regional Oncology Dispensary' of the Cherkassy Regional Council
Cherkassy, Chernihiv Governorate, DUMMY_VALUE, Ukraine
MNE Lviv Territorial Medical Association Clinical Hospital for Palliative Care
Lviv, Chernihiv Governorate, 79007, Ukraine
Khmelnytskyi Regional Hospital
Khmelnytskyi, Kharkiv Governorate, 29000, Ukraine
Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital
Cambridge, CB2 0QQ, United Kingdom
East Kent Hospitals University NHS Foundation Trust
Canterbury, CT1 3NG, United Kingdom
University Hospitals of Leicester NHS Trust - Leicester Royal Infirmary
Leicester, LE1 5WW, United Kingdom
Barts Health NHS Trust
London, EC1A 7BE, United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust. Freeman Hospital
Newcastle upon Tyne, NE7 7DN, United Kingdom
Nottingham City Hospital
Nottingham, NG5 1PB, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, OX3 7LE, United Kingdom
Related Publications (7)
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.
PMID: 40997297DERIVEDMorschhauser 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.
PMID: 40991874DERIVEDHu 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.
PMID: 40085955DERIVEDLiao 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.
PMID: 37864313DERIVEDSong 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.
PMID: 36626583DERIVEDVarma 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.
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PMID: 34904799DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2017
First Posted
September 7, 2017
Study Start
November 16, 2017
Primary Completion
April 30, 2026
Study Completion
April 30, 2026
Last Updated
February 6, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
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