A Study Comparing the Efficacy and Safety of Polatuzumab Vedotin With Rituximab-Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus... | NCT03274492 | Trialant

A Study Comparing the Efficacy and Safety of Polatuzumab Vedotin With Rituximab-Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus... | NCT03274492 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: 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

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 90024-6997, 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 33705-1455, United States

Florida Cancer Specialists & Research Institute

St. Petersburg, Florida 33705, United States

Emory University

Atlanta, Georgia 30322, United States

Illinois Cancer Specialists

Arlington Heights, Illinois 60005, United States

James Graham Brown Cancer Center

Louisville, Kentucky 40202-3229, United States

Ochsner Medical Center

New Orleans, Louisiana 70121, United States

University of Maryland

Baltimore, Maryland 21201, United States

The Johns Hopkins Hospital

Baltimore, Maryland 21205, 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

Roswell Park Cancer Institute

Buffalo, New York 14263, United States

Memorial Sloan Kettering Cancer Center at Westchester

Harrison, New York 10604-3200, 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

Memorial Sloan Kettering Cancer Center - Commack

New York, New York 10087-9049, 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

Cincinnati, Ohio 45242, United States

The Ohio State University Comprehensive Cancer Center

Cleveland, Ohio 44106, United States

University Hospitals Case Medical Center

Cleveland, Ohio 44106, 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 Health & Science University

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 Cancer Institute

Pittsburgh, Pennsylvania 15232-1309, United States

Medical University of South Carolina (MUSC)

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, Tennessee 37203-1625, 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 22031-4618, United States

Seattle Cancer Care Alliance

Seattle, Washington 98109, United States

West Virginia Uni Med. Center - Robert Byrd Health Science

Morgantown, West Virginia 26505, 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

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 de Clínicas de Porto Alegre X

Porto Alegre, Rio Grande do Sul 90035-903, 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

Cross Cancer Institute

Edmonton, Alberta T6G 1Z2, Canada

BC Cancer Agency Vancouver Centre

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

Hôpital de l'Enfant-Jésus

Québec, Quebec G1J 1Z4, Canada

Beijing Cancer Hospital

Beijing, 100142, China

The First Hospital of Jilin University

Changchun, 130021, 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, 200120, China

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

Tianjin, 300020, 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

Fakultní nemocnice Olomouc

Olomouc, 779 00, 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

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

Universitätsklinikum Halle (Saale)

Halle, 6097, Germany

Universitaetsklinikum Heidelberg

Heidelberg, 69120, Germany

InVO - Institut für Versorgungsforschung in der Onkologie GbR

Koblenz, 56068, Germany

Universitatsklinikum Munster

Münster, 48149, Germany

Asst Papa Giovanni XXIII

Bergamo, Abruzzo 24127, Italy

Asst Degli Spedali Civili Di Brescia

Brescia, Abruzzo 25123, 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 10126, 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

Cancer Trials New Zealand

Hamilton, WKO 3204, New Zealand

Auckland City Hospital, Cancer and Blood Research

Auckland, 1023, New Zealand

Canterbury Health Laboratories

Christchurch, 8011, New Zealand

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

Chorzów, 41-500, Poland

Pratia Ma?opolskie Centrum Medyczne (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 Centralny Szpital Kliniczny MON

Warsaw, 04-359, 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, 50612, South Korea

Institut Catala d Oncologia Hospitalet

L'Hospitalet de Llobregat, Barcelona 08908, Spain

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

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

Basel, 4031, Switzerland

Kaohsiung Medical University Chung-Ho Memorial Hospital

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)

Dokuz Eylul Universitesi Tip Fakultesi

Balçova, 35330, Turkey (Türkiye)

Ege Üniversitesi Tip Fakültesi

Lzmir, 35100, 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 - St Bartholomew's Hospital

London, EC1M 6BQ, United Kingdom

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

Freeman Hospital

Newcastle upon Tyne, NE7 7DN, United Kingdom

Nottingham University Hospitals NHS Trust - City Hospital

Nottingham, NG5 1PB, United Kingdom

Oxford University Hospitals NHS Foundation Trust

Oxford, OX3 7LE, United Kingdom