AzTrials
AzTrials

Large B-Cell LymphomaPhase 3NCT06047080

An Open-Label Study Comparing Glofitamab and Polatuzumab Vedotin + Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone Versus Pola-R-CHP in Previously Untreated Patients With Large B-Cell Lymphoma

A Phase 3 study testing Glofitamab, Polatuzumab vedotin and Rituximab in people with Large B-Cell Lymphoma, run by Hoffmann-La Roche at 229 sites in 21 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The purpose of this study is to compare the efficacy and safety of glofitamab in combination with polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP) vs Pola-R-CHP in participants with previously untreated CD20-positive large B-cell lymphoma (LBCL). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Large B-Cell Lymphoma
What is being tested?
Glofitamab, Polatuzumab vedotin and Rituximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,130 participants
Where
229 sitesin 21 countries
Study dates
18 Sep 2023to 30 Oct 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 CD20-positive LBCL
  • Ability to provide tumor tissue
  • International prognostic index (IPI) score 2-5
  • Eastern cooperative oncology group (ECOG) performance status of 0, 1, or 2
  • At least one bi-dimensionally measurable lesion, defined as > 1.5 cm in its longest dimension as measured by CT or MRI
  • Left ventricular ejection fraction (LVEF) >/=50% on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO)
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  • Adequate hematologic function
  • Negative HIV test at screening with exceptions as defined by the protocol
  • Negative SARS-CoV-2 antigen or PCR test

Who cannot join

  • Contraindication to any of the individual components of Pola-R-CHP or glofitamab, including prior receipt of anthracyclines, or history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, or known sensitivity or allergy to murine products
  • Prior solid organ transplantation
  • Participants receiving systemic immunosuppressive agent such as, but not limited to cyclosporin, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents within 4 weeks prior to first dose of study treatment
  • Current Grade > 1 peripheral neuropathy by clinical examination or demyelinating form of Charcot-Marie-Tooth disease
  • History of indolent lymphoma (e.g., Follicular Lymphoma, Marginal Zone Lymphoma, Waldenstrom macroglobulinemia)
  • Current diagnosis of the following: Follicular lymphoma grade 3B; transformations of indolent B-cell lymphomas (e.g., de novo transformed follicular lymphoma); mediastinal grey zone lymphoma; primary mediastinal (thymic) large B-cell lymphoma; Burkitt lymphoma; primary large B-cell lymphoma of immune-privileged sites (encompassing primary diffuse large B-cell lymphoma of the CNS, primary large B-cell lymphoma of the vitreoretina and primary large B-cell lymphoma of the testis); primary effusion DLBCL; and primary cutaneous DLBCL, leg type
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  • Primary or secondary CNS lymphoma at the time of recruitment or history of CNS lymphoma
  • Prior treatment with systemic immunotherapeutic agents
  • Prior use of any monoclonal antibody for the purposes of treating cancer within 3 months of the start of Cycle 1
  • Any investigational therapy for the purposes of treating cancer within 28 days prior to the start of Cycle 1
  • Prior radiotherapy to the mediastinal/pericardial region
  • Prior therapy for LBCL, with the exception of corticosteriods
  • Corticosteroid use > 30 mg/day of prednisone or equivalent, for purposes other than lymphoma symptom control
  • History of other malignant or non-malignant diseases that could affect compliance with the protocol or interpretation of results
  • Significant or extensive history of cardiovascular disease
  • Recent major surgery (within 4 weeks prior to the start of Cycle 1), other than for diagnosis
  • Current or past history of central nervous system (CNS) disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
  • Known or suspected chronic active Epstein-Barr viral infection
  • Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
  • Active autoimmune disease requiring treatment
  • Clinically significant liver disease
  • Live, attenuated vaccine within 4 weeks before study treatment infusion on Day 1 of Cycle 1 or anticipation that such a live, attenuated vaccine will be required during the study. Live vaccines during the study and until participants B cells recover are prohibited
  • Any active infection within 7 days prior to Cycle 1 Day 1 that would impact participant safety
  • Suspected active or latent tuberculosis
  • Positive test results for chronic hepatitis B infection, hepatitis C, or the human T-lymphotropic virus type 1 (HTLV-1)
  • History of progressive multifocal leukoencephalopathy

Trial locations and contacts

229 sites in 21 countries.

229 sites in 21 countries

United States60 sites

  • Kaiser Permanente - Anaheim (E. La Palma)

    Anaheim, California, 92806

  • Alaska Oncology & Hematology, LLC

    Anchorage, Alaska, 99508

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Boston Medical Center

    Boston, Massachusetts, 02218

  • NYU Langone Hospital?Brooklyn

    Brooklyn, New York, 11220

  • University of Vermont

    Burlington, Vermont, 05401

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27514

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • Greco-Hainesworth Tennessee Oncology Centers for Research

    Chattanooga, Tennessee, 37404

  • St. Luke's Hospital

    Chesterfield, Missouri, 63017

  • Robert H. Lurie Comprehensive Cancer Center of Northwestern University

    Chicago, Illinois, 60637-1447

  • University of California, San Francisco-Fresno

    Clovis, California, 93611

  • Texas Oncology - Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • City of Hope National Medical Center

    Duarte, California, 91010

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • West Cancer Center & Research Institute

    Germantown, Tennessee, 38138

  • Hawaii Cancer Care

    Honolulu, Hawaii, 96813

  • University of Iowa

    Iowa City, Iowa, 52242

  • City of Hope - Lennar Foundation Cancer Center

    Irvine, California, 92618

  • Rocky Mountain Cancer Center - Denver

    Littleton, Colorado, 80120

  • Valkyrie Clinical Trials

    Los Angeles, California, 90067

  • UCLA Jonsson Comprehensive Cancer Center

    Los Angeles, California, 90095

  • Univ of Wisconsin Hosp & Clin

    Madison, Wisconsin, 53792

  • Miami Cancer Institute of Baptist Health, Inc.

    Miami, Florida, 33176

  • NYU Long Island Hospital

    Mineola, New York, 11501

  • M Health Fairview University of Minnesota Medical Center

    Minneapolis, Minnesota, 55455

  • West Virginia University

    Morgantown, West Virginia, 26506

  • Tennessee Oncology

    Nashville, Tennessee, 37203

  • Yale University School Of Medicine

    New Haven, Connecticut, 06519

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121

  • New York University Medical Center PRIME

    New York, New York, 10016

  • Memorial Sloan Kettering Cancer Center David H Koch Center for Cancer Care

    New York, New York, 10021

  • Weill Cornell Medical College-New York Presbyterian Hospital

    New York, New York, 10021

  • Virginia Oncology Associates

    Newport News, Virginia, 23606

  • Henry Ford Health System

    Novi, Michigan, 48377-3600

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-0600

  • Memorial Cancer Institute at Memorial West

    Pembroke Pines, Florida, 33028

  • Illinois Cancer Care

    Peoria, Illinois, 61615

  • Kimmel Cancer Center Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • West Penn Hospital

    Pittsburgh, Pennsylvania, 15224

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • Kaiser Permanente - Roseville

    Roseville, California, 95661

  • USOR - Texas Oncology - San Antonio Northeast

    San Antonio, Texas, 78217

  • Kaiser Permanente - Santa Clara

    Santa Clara, California, 95051

  • Swedish Medical Center

    Seattle, Washington, 98104-1360

  • University of Washington - Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • North Shore Hematology Oncology Association PC

    Shirley, New York, 11967

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • Springfield Clinic

    Springfield, Illinois, 62702

  • Willamette Valley Cancer Insitute and Research Center

    Springfield, Oregon, 97477

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Stanford Univ School of Med

    Stanford, California, 94305-5821

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • New York Cancer & Blood Specialists

    The Bronx, New York, 10469

  • Kaiser Permanente Medical Ctr

    Vallejo, California, 94589

  • Medstar Franklin Square Medical Center

    Washington D.C., District of Columbia, 20010

  • Ascension Via Christi Research

    Wichita, Kansas, 67214

Other trials in United States

China26 sites

  • Beijing Cancer Hospital

    Beijing, 100142

  • Peking University Third Hospital

    Beijing, 100191

  • The First Hospital of Jilin University

    Changchun, 130021

  • Hunan Cancer Hospital

    Changsha, 410013

  • West China Hospital, Sichuan University

    Chengdu, 610041

  • Sichuan Provincial People's Hospital

    Chengdu, 610072

  • Second Affiliated Hospital of Third Military Medical University

    Chongqing, 400030

  • Fujian Cancer Hospital

    Fuzhou, 350014

  • Southern Medical University Nanfang Hospital

    Guangdong Province Guangzhou City, 510515

  • Sun yat-sen University Cancer Center

    Guangzhou, 510060

  • Zhujiang Hospital, Southern Medical University

    Guangzhou, 510280

  • Harbin Medical University Cancer Hospital

    Harbin, 150081

  • Anhui Province Cancer Hospital

    Hefei, 230031

  • Shandong Cancer Hospital

    Jinan, 250117

  • Jiangxi Cancer Hospital

    Nanchang, 330029

  • Guangxi Cancer Hospital of Guangxi Medical University

    Nanning, 530021

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

  • First Hospital of China Medical University

    Shenyang, 110001

  • Shengjing Hospital of China Medical University

    Shenyang, 110004

  • First Affiliated Hospital of Soochow University

    Suzhou, 215006

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

    Tianjin, 300020

  • Tianjin Cancer Hospital

    Tianjin, 300060

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

    Wuhan, 430022

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

    Wuhan, 430030

  • The First Affiliated Hospital of Xiamen University

    Xiamen, 361003

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, 450052

Other trials in China

Japan23 sites

  • Anjo Kosei Hospital

    Aichi, 446-8602

  • Aichi Cancer Center

    Aichi, 464-8681

  • Nagoya University Hospital

    Aichi, 466-8560

  • Chiba Cancer Center

    Chiba, 260-8717

  • National Cancer Center Hospital East

    Chiba, 277-8577

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 811-1395

  • Kyushu University Hospital

    Fukuoka, 812-8582

  • Gifu University Hospital

    Gifu, 501-1194

  • Hokkaido University Hospital

    Hokkaido, 060-8648

  • Kobe City Medical Center General Hospital

    Hyōgo, 650-0047

  • Kanagawa Cancer Center

    Kanagawa, 241-8515

  • Tokai University Hospital

    Kanagawa, 259-1193

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, 602-8566

  • Tohoku University Hospital

    Miyagi, 980-8574

  • Okayama University Hospital

    Okayama, 700-8558

  • Osaka Metropolitan University Hospital

    Osaka, 545-8586

  • Kansai Medical University Hospital

    Osaka, 573-1191

  • Kindai University Hospital

    Osaka, 589-8511

  • National Cancer Center Hospital

    Tokyo, 104-0045

  • Komagome Hospital

    Tokyo, 113-8677

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135-8550

  • Keio University Hospital

    Tokyo, 160-8582

  • Yamagata University Hospital

    Yamagata, 990-9585

Other trials in Japan

Germany17 sites

  • Charité Universitätsmedizin Berlin

    Berlin, 13353

  • Staedisches Klinikum Brandenburg

    Brandenburg an der Havel, 14770

  • Klinikum Chemnitz gGmbH, Klinik f. Innere Medizin III

    Chemnitz, 09116

  • Universitätsklinikum Köln

    Cologne, 50937

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40225

  • Universitätsklinikum Erlangen, Medizinische Klinik 5, Hämatologie und Internistische Onkologie

    Erlangen, 91054

  • Universitätsklinikum Essen

    Essen, 45122

  • Universitätsklinikum Frankfurt

    Frankfurt, 60596

  • UKE Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20251

  • Universitaetsklinikum Schleswig Holstein - Campus Luebeck

    Lübeck, 23538

  • Otto von Guericke Uni Magdeburg Uniklinik

    Magdeburg, 39120

  • Klinikum rechts der Isar der TU München, III. Medizinische Klinik

    München, 81675

  • Universitätsklinikum Münster

    Münster, 48149

  • Klinikum Ernst von Bergman

    Potsdam, 14467

  • Klinikum Stuttgart Katharinenhospital

    Stuttgart, 70174

  • Universitätsklinikum Ulm

    Ulm, 89081

  • Universitätsklinikum Würzburg

    Würzburg, 97080

Other trials in Germany

South Korea13 sites

  • Inje university Haeundae Paik Hospital

    Busan, 48108

  • Pusan National University Hospital

    Busan, 602-739

  • Keimyung University Dongsan Medical Center

    Daegu, 41931

  • Chungnam National University Hospital

    Daejeon, 35015

  • National Cancer Center

    Goyang-si, 10408

  • Chonnam National University Hwasun Hospital

    Jeollanam-do, 58128

  • Korea University Anam Hospital

    Seoul, 02841

  • Seoul National University Hospital

    Seoul, 03080

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • Seoul St Mary's Hospital

    Seoul, 06591

  • Yeouido St. Mary's Hospital

    Seoul, 07345

  • Severance Hospital, Yonsei University Health System

    Seoul, 3722

Other trials in South Korea

Australia11 sites

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

  • Eastern Health

    Box Hill, Victoria, 3128

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • Townsville Hospital

    Douglas, Queensland, 4812

  • St Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065

  • Barwon Health

    Geelong, Victoria, 3220

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000

  • Peter Maccallum Cancer Centre

    Melbourne, Victoria, 3000

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009

  • Prince of Wales Hospital- Department of Hematology

    Randwick, New South Wales, 2031

  • Princess Alexandra Hospital Woolloongabba

    Woolloongabba, Queensland, 4102

Other trials in Australia

United Kingdom11 sites

  • Barnet Hospital

    Barnet, EN5 3DJ

  • Blackpool Victoria Hospital

    Blackpool, FY3 8NR

  • East Kent Hospitals University NHS Foundation Trust

    Canterbury, CT1 3NG

  • Royal Devon and Exeter Hospital

    Exeter, EX2 5DW

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN

  • Leeds Teaching Hosp NHS Trust

    Leeds, LS9 7TF

  • University College London Hospitals NHS Foundation Trust - University College Hospital

    London, NW1 2PG

  • Guy'S Hospital

    London, SE1 9RT

  • Newcastle University

    Newcastle, NE1 4LP

  • Nottingham University Hospitals NHS Trust

    Nottingham, NG7 2UH

  • Churchill Hospital - Oxford Cancer & Haematology Centre

    Oxford, OX3 7LE

Other trials in United Kingdom

France10 sites

  • CHRU de Lille - Hopital Claude Huriez

    Lille, 59037

  • Hospices Civils de Lyon

    Lyon, 69004

  • Institut Paoli Calmettes

    Marseille, 13009

  • CHU Montpellier

    Montpellier, 34295

  • CHU de Nantes - Hotel Dieu

    Nantes, 44093

  • CHU de Bordeaux

    Pessac, 33600

  • CHU DE RENNES - CHU Pontchaillou

    Rennes, 35033

  • Centre Henri Becquerel

    Rouen, 76038

  • CHU Strasbourg Hpital Hautepierre

    Strasbourg, 67098

  • IUCT Oncopole

    Toulouse, 31100

Other trials in France

Italy9 sites

  • Asst Papa Giovanni Xxiii

    Bergamo, Lombardy, 24127

  • Policlinico S.Orsola-Malpighi

    Bologna, Emilia-Romagna, 40138

  • A. O. U. Policlinico G. Rodolico

    Catania, Sicily, 95123

  • A.O. Universitaria S. Martino Di Genova

    Genoa, Liguria, 16132

  • Fond. IRCCS Istituto Nazionale Tumori

    Milan, Lombardy, 20133

  • A.O. Universitaria Policlinico Di Modena

    Modena, Emilia-Romagna, 41124

  • Istituto Nazionale Tumori Irccs Fondazione g. Pascale

    Naples, Campania, 80131

  • Istituto Clinico Humanitas

    Rozzano, Lombardy, 20089

  • Ospedale San Bortolo

    Vicenza, Veneto, 36100

Other trials in Italy

Spain8 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

  • Clinica Universidad de Navarra Madrid

    Madrid, 28027

  • Clinica Universitaria de Navarra

    Pamplona, Navarre, 31008

  • Hospital Quiron de Madrid

    Pozuelo de Alarcón, Madrid, 28223

  • Complejo Hospitalario Universitario de Santiago (CHUS)

    Santiago de Compostela, LA Coruna, 15706

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

Other trials in Spain

Poland6 sites

  • Szpital Specjalistyczny Podkarpacki O?rodek Onkologiczny

    Brzozów, 36-200

  • Uniwersyteckie Centrum Kliniczne

    Gda?sk, 80-214

  • Pratia Onkologia Katowice

    Katowice, 41-500

  • ?wi?tokrzyskie Centrum Onkologii SPZOZ

    Kielce, 25-734

  • PRATIA MCM Kraków

    Krakow, 30-727

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

    Wroc?aw, 50-367

Other trials in Poland

Taiwan6 sites

  • Chang Gung Medical Foundation - Chai Yi

    Chai Yi, 613

  • Chang Gung Medical Foundation - Kaohsiung;Oncology

    Kaoisung, 833

  • E-Da Cancer Hospital

    Kaoshiung, 824

  • China Medical University Hospital

    Taichung, 404

  • Chi-Mei Hospital, Liouying

    Tainan, 736

  • National Taiwan University Hospital

    Taipei, 00100

Other trials in Taiwan

Canada5 sites

  • William Osler Health Centre - Brampton Civic Hospital

    Brampton, Ontario, L6R 3J7

  • Health Sciences North

    Greater Sudbury, Ontario, P3E 5J1

  • Queen Elizabeth II Health Sciences Centre

    Halifax, Nova Scotia, B3H 2Y9

  • Centre Hospitalier de l'Universite de Montreal (CHUM)

    Montreal, Quebec, H2X 0C2

  • CHA Hopital de I enfant-Jesus

    Québec, Quebec, G1J 1Z4

Other trials in Canada

Turkey (Türkiye)5 sites

  • Abdurrahman Yurtarslan Onkoloji Training and Research Hospital

    Ankara, 06200

  • Ankara Universitesi Tip Fakultesi Hastaneleri - Cebeci Hastanesi

    Ankara, 06620

  • Istanbul VKV American Hospital

    Istanbul, 34365

  • Marmara University Pendik Training and Research Hospital

    Istanbul, 34890

  • Kocaeli Univesity Medical Faculty

    İzmit, 41380

Other trials in Turkey (Türkiye)

Argentina4 sites

  • Instituto Alexander Fleming

    Buenos Aires, 1426

  • FUNDALEU

    Buenos Aires, C1114AAN

  • Hospital Aleman de Buenos Aires

    Buenos Aires, C1118AAT

  • Sanatorio Allende

    Córdoba, X5000JHQ

Other trials in Argentina

Belgium4 sites

  • Institut Jules Bordet

    Anderlecht, 1070

  • UZ Brussel

    Brussels, 1090

  • AZ Groeninge

    Kortrijk, 8500

  • CHU de Liège (Sart Tilman)

    Liège, 4000

Other trials in Belgium

Brazil3 sites

  • Hospital Erasto Gaertner

    Curitiba, Paraná, 81520-060

  • Instituto D'Or Pesquisa e Ensino

    São Paulo, São Paulo, 04502-001

  • Hospital das Clinicas - FMUSP, Oncologia

    São Paulo, São Paulo, 05403-000

Other trials in Brazil

Denmark3 sites

  • Aalborg Universitetshospital

    Aalborg, 9000

  • Aarhus Universitetshospital Skejby

    Aarhus N, 8200

  • Regionshospitalet Gødstrup

    Herning, 7400

Other trials in Denmark

Mexico3 sites

  • Hospital General de Mexico

    Mexico, Tlaxcala, 06726

  • Health Pharma Professional Research

    Mexico City, Mexico CITY (federal District), 03100

  • Inst. Nacional de Cancerologia

    Mexico City, Mexico CITY (federal District), 14000

Other trials in Mexico

Puerto Rico1 site

  • Auxilio Mutuo Cancer Center

    San Juan, 00918

Other trials in Puerto Rico

Switzerland1 site

  • Universitaetsspital Basel

    Basel, 4031

Other trials in Switzerland

About this study

Official title: A Phase III, Multicenter, Randomized, Open-Label Study Comparing the Efficacy and Safety of Glofitamab (RO7082859) in Combination With Polatuzumab Vedotin Plus Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (Pola-R-CHP) Versus Pola-R-CHP in Previously Untreated Patients With Large B-Cell Lymphoma

The purpose of this study is to compare the efficacy and safety of glofitamab in combination with polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP) vs Pola-R-CHP in participants with previously untreated CD20-positive large B-cell lymphoma (LBCL).

Being tested
Glofitamab, Polatuzumab vedotin, Rituximab, Cyclophosphamide, Doxorubicin

What participants receive

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

  • GlofitamabDrug

    Participants will receive intravenous (IV) glofitamab

  • Polatuzumab vedotinDrug

    Participants will receive IV polatuzumab vedotin in combination with R-CHP

  • RituximabDrug

    Participants will receive IV rituximab

  • CyclophosphamideDrug

    Participants will receive cyclophosphamide as part of CHP chemotherapy

  • DoxorubicinDrug

    Participants will receive IV doxorubicin

  • PrednisoneDrug

    Participants will receive oral prednisone as part of CHP chemotherapy

Study groups in NCT06047080
Study groupRoleWhat they receive
Glofitamab + Pola-R-CHPExperimentalParticipants will receive glofitamab in combination with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP).
Receives: Drug: Glofitamab; Drug: Polatuzumab vedotin; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Prednisone
Pola-R-CHPActive comparatorParticipants will receive Pola-R-CHP.
Receives: Drug: Polatuzumab vedotin; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Prednisone

What is being measured

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

  1. Progression-free survival (PFS) as determined by Independent Review Facility (IRF)

    Measured: From randomization to the first occurrence of disease progression or relapse, or death due to any cause, whichever occurs first (up to approximately 65 months)

Secondary outcomes (14)

  1. PFS as determined by the investigator

    Measured: From randomization to the first occurrence of disease progression or relapse or death from any cause, whichever occurs first (up to approximately 65 months)

  2. PFS as determined by the investigator and IRF for participants with international prognostic index (IPI) 3-5

    Measured: From randomization to the first occurrence of disease progression or relapse or death from any cause, whichever occurs first (up to 65 months)

  3. Event-free survival efficacy causes (EFSeff)

    Measured: From randomization to the earliest occurrence of disease progression or relapse; death due to any cause; initiation of new anti-lymphoma treatment; or positive biopsy for residual disease after treatment completion (up to approximately 65 months)

  4. Complete response (CR) rate

    Measured: At the end of treatment (up to approximately 65 months)

  5. Objective response rate (ORR)

    Measured: At treatment completion or discontinuation (up to approximately 65 months)

  6. Overall survival (OS)

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

  7. Duration of response (DOR)

    Measured: From the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to approximately 65 months)

  8. Duration of complete response (DOCR)

    Measured: From the first occurrence of a documented complete response (CR) to disease progression or death, whichever occurs first (up to approximately 65 months)

  9. Disease-free survival (DFS)

    Measured: From a documented CR at the end of treatment to disease progression or death, whichever occurs first (up to approximately 65 months)

  10. Serum concentration of glofitamab

    Measured: Up to approximately 65 months

  11. Incidence of anti-drug antibodies (ADAs)

    Measured: Baseline up to approximately 65 months

  12. Proportion of participants experiencing a clinically meaningful improvement in physical functioning and fatigue (EORTC QLQ-C30) and lymphoma symptoms (FACT-Lym LymS)

    Measured: Up to approximately 65 months

  13. Time to deterioration in physical functioning and fatigue (EORTC QLQ-C30) and lymphoma symptoms (FACT-Lym LymS)

    Measured: Up to approximately 65 months

  14. Percentage of Participants with Adverse Events (AEs)

    Measured: From randomization to the end of study (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 posted21 Sep 2023
  2. Study start18 Sep 2023
  3. Primary completion1 Oct 2027 (estimated)
  4. Study completion30 Oct 2030 (estimated)

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
None (open label)
Enrolment
1,130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06047080
Sponsor's protocol ID
GO44145
Status last verified
Sep 2026
First submitted
14 Sep 2023
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
Yes
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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Glofitamab, Polatuzumab vedotin and Rituximab in people with Large B-Cell Lymphoma, run by Hoffmann-La Roche at 229 sites in 21 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 26 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: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 229 sites in United States, China, Japan, Germany, South Korea and 16 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. 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?

This study is still under way. Results are not available in the source record yet.

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 determined by Independent Review Facility (IRF) (time frame: From randomization to the first occurrence of disease progression or relapse, or death due to any cause, whichever occurs first (up to approximately 65 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 NCT06047080.

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 11 Sep 2026.

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