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

  • Cancer
  • Non Hodgkin Lymphoma (NHL)
  • Diffuse Large B-Cell Lymphoma (DLBCL)
Please note that the recruitment status of the study at your site may differ from the overall study status because some study sites may recruit earlier than others.
Study Status:

Active, not recruiting

This study runs in
Cities
  • Amiens
  • Angers
  • Ankara
  • Ann Arbor
  • Arlington Heights
  • Atlanta
  • Auckland
  • Austin
  • Baltimore
  • Barcelona
  • Basel
  • Bayonne
  • bei-jing-shi
  • Berlin
  • Besançon
  • Birmingham
  • Blacksburg
  • Bordeaux
  • Boston
  • Brescia
  • Buffalo
  • Busan
  • Caen
  • Cambridge
  • Canterbury
  • Cesi
  • Chambéry
  • chang-chun-shi
  • Chapel Hill
  • Charleston
  • Charlotte
  • Chattanooga
  • Cherkasy
  • Chiba
  • Chorzów
  • Christchurch
  • Chuo City
  • Clayton
  • Cleveland
  • Columbus
  • Commack
  • Concord
  • Créteil
  • Cáceres
  • Daphne
  • Dessau-Roßlau
  • Detroit
  • Dijon
  • Duarte
  • Edmonton
  • Essen
  • Eugene
  • Fairfax
  • florida
  • Fukuoka
  • Fuzhou
  • Genova
  • Gent
  • Girona
  • Goyang-si
  • Greenville
  • Grenoble
  • guang-zhou-shi
  • Halle (Saale)
  • Hamilton
  • hang-zhou-shi
  • Harrison
  • Heidelberg
  • Hiroshima
  • Hlavní město Praha
  • Isehara
  • İzmir
  • jefferson
  • Kaohsiung City
  • Kashiwa
  • khmelnytskyi-oblast
  • Kobe
  • Koblenz
  • Kogarah
  • Koto City
  • Kraków
  • Královéhradecký kraj
  • Kumamoto
  • Kurralta Park
  • Kyiv
  • Kyoto
  • L'Hospitalet de Llobregat
  • La Louvière
  • La Roche-sur-Yon
  • La Tronche
  • la-celle-guenand
  • Le Mans
  • Leicester
  • Lille
  • Limoges
  • London
  • Los Angeles
  • Louisville
  • Lviv
  • Lyon
  • Madrid
  • Manchester
  • Messina
  • Milano
  • Montpellier
  • Montréal
  • Montvale
  • Morgantown
  • Málaga
  • Münster
  • Nagoya
  • nan-jing-shi
  • Nantes
  • Nashville
  • New York
  • Newcastle upon Tyne
  • Nice
  • Nottingham
  • Novara
  • Nîmes
  • Ohio
  • Olomouc
  • Osaka
  • Osakasayama
  • ostrava-8
  • Ottawa
  • oullins-pierre-benite
  • Oxford
  • Pamplona
  • Paraná
  • Paris
  • parker
  • Perpignan
  • Pessac
  • Philadelphia
  • Pittsburgh
  • Poitiers
  • Portland
  • Poznań
  • Quimper
  • Québec
  • Randwick
  • Reggio Emilia
  • Rennes
  • Rio Grande do Sul
  • Rochester
  • Rouen
  • Saint-Brieuc
  • Saint-Priest-en-Jarez
  • Salt Lake City
  • Salzburg
  • San Antonio
  • Sankt-Peterburg
  • Sapporo
  • Seattle
  • Sendai
  • Seoul
  • Sevilla
  • shang-hai-shi
  • Shanghai
  • Shimotsuke
  • St. Louis
  • St. Petersburg
  • Strasbourg
  • Suita
  • São Paulo
  • Taichung City
  • Tainan City
  • Taipei City
  • tian-jin-shi
  • Tianjin
  • Toronto
  • Toulouse
  • Tyler
  • Vancouver
  • Vandœuvre-lès-Nancy
  • Vannes
  • Villejuif
  • Waratah
  • Warszawa
  • Washington
  • West Palm Beach
  • Westmead
  • Wien
  • Winnipeg
  • Woodville South
  • Woolloongabba
  • wu-han-shi
  • Yangsan
  • Yvoir
  • zheng-zhou-shi
  • Łódź
Trial Identifier:

NCT03274492 2017-002023-21 GO39942

  • Aichi Cancer Center

    464-8681NagoyaJapan
  • Ankara University Faculty of Medicine Cebeci Hospital

    06700AnkaraTürkiye
  • Asan Medical Center

    05505SeoulSouth Korea
  • Ashford Cancer Center Research

    5037Kurralta ParkAustralia
  • Auckland City Hospital, Cancer and Blood Research

    2 Park Rd1023AucklandNew Zealand
  • AUSL di Reggio Emilia, IRCCS, P.O. Arcispedale Santa Maria Nuova

    80 Viale Risorgimento42123Reggio EmiliaItaly
  • Austin Hospital

    145 Studley Rd3084HeidelbergAustralia
  • Azienda Ospedaliera Papa Giovanni XXIII

    24060CesiItaly
  • Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino

    00126MessinaItaly
  • Azienda Ospedaliero Universitaria Maggiore della Carita di Novara

    28100NovaraItaly
  • Barts Health NHS Trust

    E1 1BBLondonUnited Kingdom
  • BC Cancer ? Vancouver

    600 W 10th AveV5Z 4E6VancouverCanada
  • Beijing Cancer Hospital

    52 Fu Cheng Lu100142bei-jing-shiChina
  • Calvary Mater Newcastle

    2298WaratahAustralia
  • Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital

    CB2 0QQCambridgeUnited Kingdom
  • CancerCare Manitoba (CCMB)

    675 McDermot AveR3E 0V9WinnipegCanada
  • Canterbury Health Laboratories

    8011ChristchurchNew Zealand
  • Centre Antoine Lacassagne

    33 Av. de Valombrose06100NiceFrance
  • Centre Henri Becquerel

    1 Rue d'Amiens76038RouenFrance
  • Centre Hospitalier de La Cote Basque

    13 Av. de l'Interne Jacques Loeb64100BayonneFrance
  • Centre Hospitalier de Quimper Cornouaille (CHIC)

    14 Av. Yves Thépot29000QuimperFrance
  • Centre Hospitalier de Saint Brieuc - Hôpital Yves Le Foll

    10 Rue Marcel Proust22000Saint-BrieucFrance
  • Centre Leon Berard

    28 Rue Laënnec69008LyonFrance
  • Centro de Hematologia e Hemoterapia - HEMOCENTRO UNICAMP

    571 Av. Júlio de Mesquita13025-063São PauloBrazil
  • CH Bretagne Atlantique

    20 Bd Général Maurice Guillaudot56000VannesFrance
  • CH Jolimont - Lobbes (Jolimont)

    7100La LouvièreBelgium
  • CH Metropole de Savoie

    73000ChambéryFrance
  • CHD Vendée

    59 Rue Laplace85000La Roche-sur-YonFrance
  • Chi-Mei Hospital, Liouying

    736Tainan CityTaiwan
  • Chiba Cancer Center

    260-0801ChibaJapan
  • Chiba University Hospital

    260-8677ChibaJapan
  • China Medical University Hospital

    40447Taichung CityTaiwan
  • Chru de Strasbourg

    1 Pl. de l'Hôpital67000StrasbourgFrance
  • CHU Amiens - Hopital Sud

    80480AmiensFrance
  • CHU Angers

    4 Rue Larrey49100AngersFrance
  • CHU Bretonneau

    37350la-celle-guenandFrance
  • CHU de Brabois

    54500Vandœuvre-lès-NancyFrance
  • CHU de Dijon - Hopital le Bocage

    14 Rue Paul Gaffarel21000DijonFrance
  • CHU de Nantes - Hotel Dieu

    1 Pl. Alexis-Ricordeau44000NantesFrance
  • CHU de Nîmes - Hôpital Carémeau

    4 Rue du Professeur Robert Debré30900NîmesFrance
  • CHU de Poitiers

    2 Rue de la Milétrie86000PoitiersFrance
  • CHU de Quebec-Universite Laval

    11 Côte du PalaisG1R 2J6QuébecCanada
  • CHU Lyon Sud - Service Hématologie

    165 Chem. du Grand Revoyet69495oullins-pierre-beniteFrance
  • CHU Montpellier - Saint ELOI

    34090MontpellierFrance
  • CHU UCL Mont-Godinne

    1 Rue Dr Gaston Therasse5530YvoirBelgium
  • City of Hope

    1500 E Duarte Rd91010DuarteUnited States
  • CIUSSS de l Est de l Ile de Montreal - Hopital Maisonneuve Rosemont

    7400 Bd Saint-MichelH2A 2Z8MontréalCanada
  • Clinique Victor Hugo - Centre Jean Bernard

    64 Rue de Degré72015Le MansFrance
  • Communal Institution 'Cherkassy Regional Oncology Dispensary' of the Cherkassy Regional Council

    18000CherkasyUkraine
  • Complejo Hospitalario de Navarra

    3 C. de Irunlarrea31008PamplonaSpain
  • Concord Repatriation General Hospital

    2139ConcordAustralia
  • Dana Farber Cancer Institute

    02115BostonUnited States
  • Dokuz Eylul Universitesi Tip Fakultesi

    35340İzmirTürkiye
  • East Kent Hospitals University NHS Foundation Trust

    CT1 3NGCanterburyUnited Kingdom
  • Ege Üniversitesi Tip Fakültesi

    9 Ege Ünv. Ögrenci Köyü İç Yol35100İzmirTürkiye
  • Emory University

    201 Dowman Dr30322AtlantaUnited States
  • Fakultni Nemocnice Hradec Kralove (FNHK)

    581 Sokolská500 05Královéhradecký krajCzechia
  • Fakultni Nemocnice Kralovske Vinohrady (FNKV)

    100 34Hlavní město PrahaCzechia
  • Fakultni nemocnice Olomouc

    775 20OlomoucCzechia
  • Fakultni nemocnice Ostrava

    1790/5 17. listopadu708 00ostrava-8Czechia
  • Feofaniya Center of Haematology and Chemotherapy of Haemoblastosis

    02000KyivUkraine
  • Florida Cancer Specialists

    1309 N Flagler Dr33401West Palm BeachUnited States
  • Florida Cancer Specialists - Fort Myers (New Hampshire Ct)

    33908floridaUnited States
  • Florida Cancer Specialists & Research Institute

    1201 5th Ave N33705St. PetersburgUnited States
  • Fox Chase Cancer Center

    333 Cottman Ave19111PhiladelphiaUnited States
  • Fudan University Shanghai Cancer Center

    270号 Dong An Lu200032shang-hai-shiChina
  • Fujian Provincial Cancer Hospital

    350014FuzhouChina
  • Fundación Jimenez Díaz

    2 Av. de los Reyes Católicos28040MadridSpain
  • Georgetown University Medical Center

    20057WashingtonUnited States
  • Gh Necker Enfants Malades

    149 Rue de Sèvres75015ParisFrance
  • Greco-Hainesworth Centers for Research

    37403ChattanoogaUnited States
  • Henan Cancer Hospital

    127 北127450003zheng-zhou-shiChina
  • Hiroshima University Hospital

    734-0037HiroshimaJapan
  • Hokkaido University Hospital

    060-8648SapporoJapan
  • Hôpital Albert Michallon

    38700La TroncheFrance
  • Hopital Claude Huriez

    59000LilleFrance
  • Hopital Haut-Leveque - Centre Francois Magendie

    33600PessacFrance
  • Hopital Henri Mondor

    94010CréteilFrance
  • Hopital Jean Minjoz

    3 Bd Alexandre Fleming25000BesançonFrance
  • Hopital Pontchaillou

    2 Rue Henri le Guilloux35000RennesFrance
  • Hopital Saint Jean

    66000PerpignanFrance
  • Hôpital Saint Vincent de Paul

    59000LilleFrance
  • Hôpital Saint-Louis

    75010ParisFrance
  • Hopital Uni Ire Dupuytren

    2 Av. Martin Luther King87000LimogesFrance
  • Hospital Clinic Barcelona

    170 Carrer de Villarroel08036BarcelonaSpain
  • Hospital das Clinicas - FMUSP

    225 R. Dr. Ovídio Pires de Campos05403-010São PauloBrazil
  • Hospital das Clinicas - UFRGS

    297 Av. Protásio Alves90410-000Rio Grande do SulBrazil
  • Hospital de la Santa Creu i Sant Pau

    89 Carrer de Sant Quintí08025BarcelonaSpain
  • Hospital Erasto Gaertner

    201 R. Dr. Ovande do Amaral81520-060ParanáBrazil
  • Hospital of the University of Pennsylvania

    3400 Spruce St19104PhiladelphiaUnited States
  • Hospital Quiron Madrid

    28233MadridSpain
  • Hospital San Pedro de Alcantara

    s/n Av. Pablo Naranjo Porras10003CáceresSpain
  • Hospital Universitari Dr. Josep Trueta

    S/N Avinguda de França17007GironaSpain
  • Hospital Universitari Vall d'Hebron

    119 Pg. de la Vall d'Hebron08035BarcelonaSpain
  • Hospital Universitario La Paz

    261 P.º de la Castellana28046MadridSpain
  • Hospital Universitario Virgen de la Victoria

    S/N Campus de Teatinos29010MálagaSpain
  • Hospital Universitario Virgen del Rocio

    S/n Av. Manuel Siurot41013SevillaSpain
  • Illinois Cancer Specialists

    880 W Central Rd60005Arlington HeightsUnited States
  • Institut Bergonie

    33076BordeauxFrance
  • Institut Catala d Oncologia Hospitalet

    08908L'Hospitalet de LlobregatSpain
  • Institut d'Hématologie de Basse Normandie

    14000CaenFrance
  • Institut Gustave Roussy

    94800VillejuifFrance
  • Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)

    1 Av. Irène Joliot-Curie31100ToulouseFrance
  • Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

    300020TianjinChina
  • InVO - Institut für Versorgungsforschung in der Onkologie GbR

    5 Neversstraße56068KoblenzGermany
  • IRCCS AOU San Martino - IST

    16132GenovaItaly
  • Istituto Nazionale dei Tumori

    1 Via Giacomo Venezian20133MilanoItaly
  • Jiangsu Cancer Hospital

    42 百子亭210009nan-jing-shiChina
  • Jichi Medical University Hospital

    329-0431ShimotsukeJapan
  • Johns Hopkins University

    21218BaltimoreUnited States
  • Kaohsiung Medical University Hospital, Cancer Center

    100號 Ziyou 1st Rd80756Kaohsiung CityTaiwan
  • Karmanos Cancer Center

    48201DetroitUnited States
  • Khmelnytskyi Regional Hospital

    29000khmelnytskyi-oblastUkraine
  • Kindai University Hospital

    589-8511OsakasayamaJapan
  • Kobe City Medical Center General Hospital

    650-0047KobeJapan
  • Kumamoto University Hospital

    860-8556KumamotoJapan
  • Kyushu University Hospital

    812-8582FukuokaJapan
  • L'Union Mutualiste de la Gestion des Eaux Claires - Institut Daniel Hollard

    22 Bd Joseph Vallier38000GrenobleFrance
  • Leningrad Regional Clinical Hospital

    6 Ulitsa Chapygina197376Sankt-PeterburgRussia
  • Levine Cancer Institute - Clincal Trials Administration

    1021 Morehead Medical Dr28204CharlotteUnited States
  • Massachusetts General Hospital

    55 Fruit St02114BostonUnited States
  • Medical University of South Carolina Hospital

    268 Calhoun St29425CharlestonUnited States
  • Medizinische Universität Wien

    23 Spitalgasse1090WienAustria
  • Memorial Sloan Kettering Bergen

    225 Summit Ave07645MontvaleUnited States
  • Memorial Sloan Kettering Cancer Center

    10065New YorkUnited States
  • Memorial Sloan Kettering Cancer Center - Commack

    650 Commack Rd11725CommackUnited States
  • Memorial Sloan Kettering Cancer Center at Westchester

    500 Westchester Ave10604HarrisonUnited States
  • MNE Lviv Territorial Medical Association Clinical Hospital for Palliative Care

    79000LvivUkraine
  • Monash Medical Centre

    246 Clayton Rd3168ClaytonAustralia
  • National Cancer Center

    10408Goyang-siSouth Korea
  • National Cancer Center Hospital

    104-0045Chuo CityJapan
  • National Cancer Center Hospital East

    277-8577KashiwaJapan
  • National Hospital Organization Kyushu Cancer Center

    811-1395FukuokaJapan
  • National Taiwan University Hospital

    7號 Zhongshan S Rd100Taipei CityTaiwan
  • New York University Cancer Cen

    160 E 34th St10016New YorkUnited States
  • Northwest Cancer Specialists - Portland (SW Barnes Rd)

    97225PortlandUnited States
  • Nottingham City Hospital

    NG5 1PBNottinghamUnited Kingdom
  • Ochsner Medical Center

    1514 Jefferson Hwy70121jeffersonUnited States
  • Ohio State University

    281 W Lane Ave43210ColumbusUnited States
  • Oncology Associates of Oregon, P.C

    97401EugeneUnited States
  • Oncology Associates of Southwest Virginia, Inc.

    24060BlacksburgUnited States
  • Oncology/Hematology Care Clinical Trials LLC

    45236OhioUnited States
  • Oregon HSU

    3181 SW Sam Jackson Park Rd97239PortlandUnited States
  • Osaka Metropolitan University Hospital

    545-0051OsakaJapan
  • Osaka University Hospital

    565-0871SuitaJapan
  • Oxford University Hospitals NHS Foundation Trust

    OX3 7LEOxfordUnited Kingdom
  • Paracelsus Medizinischen Privatuniversitaet-Salzburger Landeskliniken (SALK)

    21 Strubergasse5020SalzburgAustria
  • Pôle de Cancérologie ? CHU de Saint?Etienne'

    42270Saint-Priest-en-JarezFrance
  • PRATIA MCM Kraków

    2 Pana Tadeusza30-727KrakówPoland
  • Prince of Wales Hospital

    320-346 Barker St2031RandwickAustralia
  • Princess Alexandra Hospital Woolloongabba

    199 Ipswich Rd4102WoolloongabbaAustralia
  • Prisma Health ? Upstate

    701 Grove Rd29605GreenvilleUnited States
  • Pusan National University Hospital

    49241BusanSouth Korea
  • Pusan National University Yangsan Hospital

    50612YangsanSouth Korea
  • Rocky Mountain Cancer Centers, LLP

    9397 Crown Crest Blvd80138parkerUnited States
  • Ronald Reagan UCLA Medical Center

    757 Westwood Plaza90095Los AngelesUnited States
  • Roswell Park Cancer Institute

    665 Elm St14203BuffaloUnited States
  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    197号 瑞金二路200031shang-hai-shiChina
  • Samodzielny Publiczny Zak?ad Opieki Zdrowotnej Zespó? Szpitali Miejskich w Chorzowie

    7 Truchana41-500ChorzówPoland
  • Samsung Medical Center

    06351SeoulSouth Korea
  • Seattle Cancer Care Alliance

    820 Yale Ave N98109SeattleUnited States
  • Seoul National University Hospital

    03080SeoulSouth Korea
  • Severance Hospital

    03722SeoulSouth Korea
  • Shanghai East Hospital, Tongji University

    200032ShanghaiChina
  • Southern Cancer Center

    29653 Anchor Cross Blvd36526DaphneUnited States
  • SPZOZ Ministerstwa Spraw Wewn?trznych i Administracji w Poznaniu

    1 Hawelańska61-001PoznańPoland
  • St George Hospital

    2217KogarahAustralia
  • Städtisches Klinikum Dessau

    06847Dessau-RoßlauGermany
  • Sun Yet-sen University Cancer Center

    135号 新港西路510275guang-zhou-shiChina
  • Sunnybrook Health Sciences Centre

    2075 Bayview AveM4N 3M5TorontoCanada
  • Taipei Veterans General Hospital

    201號 Section 2, Shipai Rd112Taipei CityTaiwan
  • Tennessee Oncology - Nashville

    250 25th Ave N37203NashvilleUnited States
  • Texas Oncology San Antonio Medical Center

    5206 Research Dr78240San AntonioUnited States
  • Texas Oncology-Austin Midtown

    901 W 38th St78705AustinUnited States
  • Texas Oncology-Tyler

    501 S Saunders Ave75702TylerUnited States
  • The Cancer Institute Hospital of JFCR

    135-8550Koto CityJapan
  • The Christie NHS Foundation Trust

    M20 4BXManchesterUnited Kingdom
  • The First Affiliated Hospital of College of Medicine, Zhejiang University

    79 Qing Chun Lu310006hang-zhou-shiChina
  • The First Hospital of Jilin University

    3808 Jie Fang Da Lu130021chang-chun-shiChina
  • The Newcastle upon Tyne Hospitals NHS Foundation Trust. Freeman Hospital

    NE7 7DNNewcastle upon TyneUnited Kingdom
  • The Ottawa Hospital

    501 Smyth RdK1H 8L6OttawaCanada
  • The University of Adelaide - The Queen Elizabeth Hospital (TQEH)

    28 Woodville Rd5011Woodville SouthAustralia
  • Tianjin Medical University Cancer Institute & Hospital

    300060tian-jin-shiChina
  • Tohoku University Hospital

    980-8574SendaiJapan
  • Tokai University Hospital

    259-1193IseharaJapan
  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    430014wu-han-shiChina
  • Universita degli Studi Di Brescia - Azienda Ospedaliera Spedali Civili di Brescia

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

    DUMMY_VALUECesiItaly
  • Universitaetsklinikum Halle (Saale)

    40 Ernst-Grube-Straße06120Halle (Saale)Germany
  • Universitaetsklinikum Heidelberg

    672 Im Neuenheimer Feld69120HeidelbergGermany
  • Universitätsklinikum Essen

    55 Hufelandstraße45147EssenGermany
  • Universitatsklinikum Munster

    1 Albert-Schweitzer-Campus48149MünsterGermany
  • Universitätsspital Basel Gynäkologie - Onkologie

    21 Spitalstrasse4056BaselSwitzerland
  • University Hospital Kyoto Prefectural University of Medicine

    602-8566KyotoJapan
  • University Hospitals Case Medical Center

    11100 Euclid Ave44106ClevelandUnited States
  • University Hospitals of Leicester NHS Trust - Leicester Royal Infirmary

    LE1 5WWLeicesterUnited Kingdom
  • University of Alabama at Birmingham

    35294BirminghamUnited States
  • University of Alberta Hospital

    8440 112 St NWT6G 2B7EdmontonCanada
  • University of Louisville Hospital

    530 S Jackson St40202LouisvilleUnited States
  • University of Maryland

    21201BaltimoreUnited States
  • University of Michigan Health System

    1500 E Medical Center Dr48109Ann ArborUnited States
  • University of North Carolina at Chapel Hill

    27514Chapel HillUnited States
  • University of Pittsburgh Medical Center Cancer Center

    600 Grant St15219PittsburghUnited States
  • University of Rochester Medical Center

    601 Elmwood Ave14642RochesterUnited States
  • University of Utah

    84112Salt Lake CityUnited States
  • Univerzita Karlova v Praze 1. Lekarska Fakulta

    32 Kateřinská120 00Hlavní město PrahaCzechia
  • UZ Gent

    10 Corneel Heymanslaan9000GentBelgium
  • Virginia Cancer Specialists, PC

    22031FairfaxUnited States
  • Vivantes Klinikum Am Urban

    1 Dieffenbachstraße10967BerlinGermany
  • Waikato Hospital

    183 Pembroke St3204HamiltonNew Zealand
  • Washington University

    4921 Parkview Pl63110St. LouisUnited States
  • West Virginia Uni Med. Center - Robert Byrd Health Science

    26506MorgantownUnited States
  • Westmead Hospital

    2145WestmeadAustralia
  • Wiener Gesundheitsverbund ? Klinik Ottakring

    37 Montleartstraße1160WienAustria
  • Wojewódzki Szpital Specjalistyczny im. M. Kopernika

    62 Pabianicka93-513ŁódźPoland
  • Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy

    128 Szaserów04-141WarszawaPoland
    Show study locations

    The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

    The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

    Results Disclaimer

    Study 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).

    Hoffmann-La Roche Sponsor
    Phase 3 Phase
    NCT03274492, GO39942, 2017-002023-21 Trial Identifier
    Polatuzumab Vedotin, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Vincristine Placebo, Prednisone, Polatuzumab vedotin Placebo Treatments
    Diffuse Large B-Cell Lymphoma Condition
    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

    Eligibility Criteria

    All Gender
    ≥ 18 Years & ≤ 80 Years Age
    No Healthy Volunteers
    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

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