Back to resultsA 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)
Primary Purpose
Diffuse Large B-Cell Lymphoma
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Polatuzumab Vedotin
Rituximab
Cyclophosphamide
Doxorubicin
Vincristine
Vincristine Placebo
Prednisone
Polatuzumab vedotin Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diffuse Large B-Cell Lymphoma
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
Sites / Locations
- University of Alabama at Birmingham
- Southern Cancer Center
- City of Hope
- Ronald Reagan UCLA Medical Center; Drug Information Center
- Georgetown University Medical Center
- Florida Cancer Specialists - Fort Myers (New Hampshire Ct)
- Florida Cancer Specialists & Research Institute
- Florida Cancer Specialists
- Emory University; Investigational Drug Service
- Illinois Cancer Specialists
- University of Louisville Hospital; The James Graham Brown Cancer Center
- Ochsner Medical Center
- University of Maryland
- Johns Hopkins University
- Massachusetts General Hospital
- Dana Farber Cancer Institute; Lymphoma Program
- Beth Israel Deaconess Medical Center
- University of Michigan Health System; UMH Internal Medicine/Hematology-Oncology
- Karmanos Cancer Center
- HCA Midwest Division
- Washington University; Wash Uni. Sch. Of Med
- Memorial Sloan Kettering Bergen
- Roswell Park Cancer Institute; Grace Cancer Drug Center
- Memorial Sloan Kettering Cancer Center - Commack
- Memorial Sloan Kettering Cancer Center at Westchester
- New York University Cancer Cen
- Memorial Sloan Kettering Cancer Center
- University of Rochester Medical Center
- University of North Carolina at Chapel Hill
- Levine Cancer Institute - Clincal Trials Administration
- University Hospitals Case Medical Center
- Ohio State University; B406 Starling-Loving Hall
- Oncology/Hematology Care Clinical Trials LLC
- Oncology Associates of Oregon, P.C
- Oregon HSU; Bld-Brain Barr/Neuro-Onc
- Northwest Cancer Specialists - Portland (SW Barnes Rd)
- Hospital of the University of Pennsylvania
- Fox Chase Cancer Center; Hematology/Oncology
- University of Pittsburgh Medical Center Cancer Center; Pharmacy
- Medical University of South Carolina Hospital
- Prisma Health ? Upstate
- Tennessee Oncology - Chattanooga; Tennessee Oncology - East Third Street
- Sarah Cannon Research Institute
- Texas Oncology-Austin Midtown
- Rocky Mountain Cancer Centers, LLP
- Texas Oncology-Tyler
- Texas Oncology San Antonio Medical Center
- University of Utah; Huntsman Cancer Hospital
- Oncology Associates of Southwest Virginia, Inc.
- Virginia Cancer Specialists, PC
- Shenandoah Oncology Associates
- Seattle Cancer Care Alliance; Investigational Drug Service
- North Star Lodge
- West Virginia Uni Med. Center - Robert Byrd Health Science
- Concord Repatriation General Hospital
- St George Hospital
- Prince of Wales Hospital; Haematology
- Calvary Mater Newcastle
- Westmead Hospital; Outpatient Pharmacy University Clinic
- Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology
- Ashford Cancer Center Research
- The University of Adelaide - The Queen Elizabeth Hospital (TQEH)
- Monash Medical Centre
- Austin Hospital; Cancer Clinical Trials Centre
- Medizinische Universitaet Innsbruck - Universitaetsklinik fuer Innere Medizin III
- Landesklinikum Krems
- Paracelsus Medizinischen Privatuniversitaet-Salzburger Landeskliniken (SALK)
- Medizinische Universität Wien
- Wiener Gesundheitsverbund ? Klinik Ottakring
- UZ Gent
- CH Jolimont - Lobbes (Jolimont)
- CHU UCL Mont-Godinne
- Hospital Erasto Gaertner
- Hospital Sao Vicente de Paulo
- Hospital das Clinicas - UFRGS
- Centro de Hematologia e Hemoterapia - HEMOCENTRO UNICAMP
- Hospital das Clinicas - FMUSP
- University of Alberta Hospital
- BC Cancer ? Vancouver
- CancerCare Manitoba (CCMB)
- McMaster University Medical Center, Juravinski Cancer Centre, Hamilton Health Sciences
- The Ottawa Hospital
- Sunnybrook Health Sciences Centre
- University Health Network; Princess Margaret Hospital; Medical Oncology Dept
- CIUSSS de l'Est-de-l'Ile-de-Montréal - Hôpital Maisonneuve-Rosemont
- Centre Hospitalier de l'Universite de Montreal - Pavillon E (PEA)
- CHU de Quebec-Universite Laval
- Peking Union Medical College Hospital
- Beijing Cancer Hospital
- The First Hospital of Jilin University
- Fujian Provincial Cancer Hospital
- Sun Yet-sen University Cancer Center
- The First Affiliated Hospital of College of Medicine, Zhejiang University
- Jiangsu Cancer Hospital
- Jiangsu Province Hospital
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine
- Shanghai East Hospital, Tongji University
- Fudan University Shanghai Cancer Center
- Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
- Tianjin Medical University Cancer Institute & Hospital
- Union Hospital Tongji Medical College Huazhong University of Science and Technology
- Henan Cancer Hospital
- Fakultni Nemocnice Hradec Kralove (FNHK); IV. Interni Hematologicka Klinika
- Fakultni Nemocnice Kralovske Vinohrady (FNKV); Interni Hematologicka Klinika
- Fakultni nemocnice Olomouc
- Fakultni nemocnice Ostrava
- Univerzita Karlova v Praze 1. Lekarska Fakulta
- CHU Amiens - Hopital Sud; Hematologie Clinique et Therapie Cellulaire
- CHU Angers
- Centre Hospitalier de La Cote Basque; Hematologie
- Hopital Jean Minjoz; Hematologie
- Institut Bergonie
- Institut d'Hématologie de Basse Normandie
- CH Metropole de Savoie
- Hopital Henri Mondor; Hematologie Clinique
- CHU de Dijon - Hopital le Bocage
- L'Union Mutualiste de la Gestion des Eaux Claires - Institut Daniel Hollard
- CHD Vendée
- Hôpital Albert Michallon; Hematologie Clinique
- Clinique Victor Hugo - Centre Jean Bernard
- Hôpital Saint Vincent de Paul
- Hopital Claude Huriez; Hematologie
- Hopital Uni Ire Dupuytren; Hematologie
- Centre Leon Berard
- CHU Montpellier - Saint ELOI
- CHU de Nantes - Hotel Dieu
- Centre Antoine Lacassagne
- CHU de Nîmes - Hôpital Carémeau
- Hôpital Saint-Louis; Service d'Hématologie
- Gh Necker Enfants Malades; Hematologie Clinique
- Hopital Saint Jean; Hematologie
- Hopital Haut-Leveque - Centre Francois Magendie; Service d'Hematologie Clinique
- CHU Lyon Sud - Service Hématologie
- CHU de Poitiers
- Centre Hospitalier de Quimper Cornouaille (CHIC); Médecine interne-Maladies du sang
- Hopital Pontchaillou; Hematologie Clinique
- Centre Henri Becquerel; Hematologie
- Centre Hospitalier de Saint Brieuc - Hôpital Yves Le Foll
- Pôle de Cancérologie ? CHU de Saint?Etienne'
- CHRU DE STRASBOURG; Département d?Hématologie et Oncologie
- Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)
- CHU Bretonneau
- CHU de Brabois
- CH Bretagne Atlantique; Médecine interne
- Institut Gustave Roussy; Unite D'Hematologie
- Vivantes Klinikum Am Urban
- Städtisches Klinikum Dessau
- Universitätsklinikum Essen
- Universitaetsklinikum Halle (Saale)
- Universitaetsklinikum Heidelberg
- InVO - Institut für Versorgungsforschung in der Onkologie GbR
- University of Munich
- Universitatsklinikum Munster
- Queen Mary Hospital
- Queen Elizabeth Hospital
- Azienda Ospedaliera Papa Giovanni XXIII
- Universita degli Studi Di Brescia - Azienda Ospedaliera Spedali Civili di Brescia
- Universita degli Studi di Roma ''La Sapienza" - Clinica Ematologica
- Azienda Ospedaliera Universitaria Senese
- AUSL di Reggio Emilia, IRCCS, P.O. Arcispedale Santa Maria Nuova
- IRCCS AOU San Martino - IST
- Fondazione IRCCS Istituto Nazionale dei Tumori - s.c. Ematologia
- Istituto Nazionale dei Tumori
- Azienda Ospedaliero Universitaria Maggiore della Carita di Novara
- Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino; Ospedale Molinette
- Aichi Cancer Center
- Chiba University Hospital
- Chiba Cancer Center
- National Cancer Center Hospital East
- National Hospital Organization Kyushu Cancer Center
- Kyushu University Hospital
- Hiroshima University Hospital
- Hokkaido University Hospital
- Kobe City Medical Center General Hospital
- Tokai University Hospital
- Kumamoto University Hospital
- University Hospital Kyoto Prefectural University of Medicine
- Tohoku University Hospital
- Osaka Metropolitan University Hospital
- Osaka University Hospital
- Kindai University Hospital
- Jichi Medical University Hospital
- National Cancer Center Hospital
- The Cancer Institute Hospital of JFCR
- Inje University Busan Paik Hospital
- Pusan National University Hospital
- National Cancer Center; Medical Oncology
- Seoul National University Hospital
- Severance Hospital
- Asan Medical Center
- Samsung Medical Center
- Pusan National University Yangsan Hospital; hemato-oncology
- Auckland City Hospital, Cancer and Blood Research
- Canterbury Health Laboratories; Immunology/Rheumatology
- Waikato Hospital
- Palmerston North Hospital
- Wojewódzki Szpital Specjalistyczny im. M. Kopernika; Klinika Hematologii UM w ?odzi
- Samodzielny Publiczny Zak?ad Opieki Zdrowotnej Zespó? Szpitali Miejskich w Chorzowie
- PRATIA MCM Kraków
- SPZOZ Ministerstwa Spraw Wewn?trznych i Administracji w Poznaniu; Oddzia? Hematologii
- Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
- Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy
- Leningrad Regional Clinical Hospital
- Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
- Penza Regional Oncology Dispensary
- Institut Catala d Oncologia Hospitalet
- Hospital Universitario Puerta de Hierro - Majadahonda
- Complejo Hospitalario de Navarra
- Hospital de la Santa Creu i Sant Pau
- Hospital Universitari Vall d'Hebron
- Hospital Clinic Barcelona
- Hospital San Pedro de Alcantara
- Hospital Universitari Dr. Josep Trueta
- Hospital Universitario La Paz
- Hospital Quiron Madrid
- Fundación Jimenez Díaz
- Hospital Universitario Virgen de la Victoria
- Hospital Universitario Virgen del Rocio
- Hirslanden Medical Center - Tumorzentrum
- Universitätsspital Basel Gynäkologie - Onkologie
- Hopital Cantonal Universitaire De Geneve
- Kaohsiung Medical University Hospital, Cancer Center
- China Medical University Hospital; Clinical Research Center Clinical Pharmacy
- Chi-Mei Hospital, Liouying
- Taipei Veterans General Hospital
- National Taiwan University Hospital
- Ankara University Faculty of Medicine Cebeci Hospital
- Ege Üniversitesi Tip Fakültesi
- Dokuz Eylul Universitesi Tip Fakultesi
- Vehbi Koc Vakfi (VKV) - Amerikan Hastanesi
- Communal Institution 'Cherkassy Regional Oncology Dispensary' of the Cherkassy Regional Council
- MNE Lviv Territorial Medical Association Clinical Hospital for Palliative Care
- Khmelnytskyi Regional Hospital; Department of Hemathology
- Feofaniya Center of Haematology and Chemotherapy of Haemoblastosis
- Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital
- East Kent Hospitals University NHS Foundation Trust
- University Hospitals of Leicester NHS Trust - Leicester Royal Infirmary
- Barts Health NHS Trust; Bartholomew's H., King George V Building
- The Christie NHS Foundation Trust
- The Newcastle upon Tyne Hospitals NHS Foundation Trust. Freeman Hospital
- Nottingham City Hospital; Dept of Haematology
- Oxford University Hospitals NHS Foundation Trust
- University Hospital Southampton NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
R-CHP plus Vincristine Placebo plus Polatuzumab Vedotin
R-CHOP plus Polatuzumab Vedotin Placebo
Arm Description
Participants 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.
Participants 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.
Outcomes
Primary Outcome Measures
Progression-Free Survival (PFS) as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma
Secondary Outcome Measures
Percentage of Participants With Complete Response (CR) as Assessed by Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) by Blinded Independent Central Review (BICR)
Event-Free Survival-Efficacy (EFSeff) as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma
Percentage of Participants Who are Progression Free as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma
Overall Survival
Percentage of Participants With CR as Assessed by FDG-PET by Investigator
Disease-Free Survival (DFS) as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma
Duration of Response as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma
Event-Free Survival-All Causes (EFSall) as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma
Time to Deterioration in European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30) Physical Functioning and Fatigue
Time to Deterioration in Functional Assessment of Cancer Therapy-Lymphoma Lymphoma Subscale (FACT-Lym LymS)
Percentage of Participants Achieving Meaningful Improvement in EORTC QLQ-C30 Physical Functioning and Fatigue
Percentage of Participants Achieving Meaningful Improvement in FACT-Lym LymS
EORTC QLQ-C30 Treatment-Related Symptoms Score
Functional Assessment of Cancer Treatment/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) Peripheral Neuropathy Score
Percentage of Participants With adverse Events (AEs)
Serum Concentration of Total Polatuzumab Vedotin
Plasma Concentration of Polatuzumab Vedotin Conjugate (Antibody-Conjugated Mono-Methyl Auristatin E [acMMAE])
Plasma Concentration of Polatuzumab Vedotin Unconjugated MMAE
Percentage of Participants With Anti-Drug Antibody (ADA) to Polatuzumab Vedotin
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03274492
Brief Title
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
Acronym
POLARIX
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 16, 2017 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B-Cell Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
R-CHP plus Vincristine Placebo plus Polatuzumab Vedotin
Arm Type
Experimental
Arm Description
Participants 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.
Arm Title
R-CHOP plus Polatuzumab Vedotin Placebo
Arm Type
Placebo Comparator
Arm Description
Participants 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.
Intervention Type
Drug
Intervention Name(s)
Polatuzumab Vedotin
Other Intervention Name(s)
DCDS4501A; anti-CD79b-VC-MMAE
Intervention Description
Polatuzumab vedotin IV infusion will be administered as per the schedule specified in the respective arm.
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
Rituximab IV infusion will be administered as per the schedule specified in the respective arm.
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Intervention Description
Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.
Intervention Type
Drug
Intervention Name(s)
Vincristine
Intervention Description
Vincristine IV infusion will be administered as per the schedule specified in the respective arm.
Intervention Type
Drug
Intervention Name(s)
Vincristine Placebo
Intervention Description
Placebo matching to vincristine will be administered as per the schedule specified in the respective arm.
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
Prednisone PO will be administered as per the schedule specified in the respective arm.
Intervention Type
Drug
Intervention Name(s)
Polatuzumab vedotin Placebo
Intervention Description
Placebo matching to polatuzumab vedotin will be administered as per the schedule specified in the respective arm.
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS) as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma
Time Frame
From randomization to the first occurrence of disease progression or relapse, or death from any cause, whichever occurs earlier (up to 38 months)
Secondary Outcome Measure Information:
Title
Percentage of Participants With Complete Response (CR) as Assessed by Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) by Blinded Independent Central Review (BICR)
Time Frame
End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 8 [Cycle length=21 days] [up to Week 32])
Title
Event-Free Survival-Efficacy (EFSeff) as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma
Time Frame
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)
Title
Percentage of Participants Who are Progression Free as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma
Time Frame
24 months after enrollment (up to approximately 65 months)
Title
Overall Survival
Time Frame
From randomization until death from any cause (up to approximately 65 months)
Title
Percentage of Participants With CR as Assessed by FDG-PET by Investigator
Time Frame
End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 8 [Cycle length=21 days] [up to Week 32])
Title
Disease-Free Survival (DFS) as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma
Time Frame
From the date of first occurrence of a documented CR to the date of relapse or death from any cause (up to approximately 65 months)
Title
Duration of Response as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma
Time Frame
From the date of first occurrence of a documented CR or partial response (PR) to the date of progression, relapse, or death from any cause (up to approximately 65 months)
Title
Event-Free Survival-All Causes (EFSall) as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma
Time Frame
From randomization to disease progression or relapse, or death from any cause, or initiation of any NALT (up to approximately 65 months)
Title
Time to Deterioration in European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30) Physical Functioning and Fatigue
Time Frame
Day 1 of Cycles 1, 2, 3 and 5 (Cycle length=21 days); treatment completion visit (TCV)/early treatment termination visit (ETTV) (up to approximately 32 weeks); post-treatment follow-up (FU) visit (up to approximately 65 months)
Title
Time to Deterioration in Functional Assessment of Cancer Therapy-Lymphoma Lymphoma Subscale (FACT-Lym LymS)
Time Frame
Day 1 of Cycles 1, 2, 3 and 5 (Cycle length=21 days); TCV/ETTV (up to approximately 32 weeks); post-treatment FU visit (up to approximately 65 months)
Title
Percentage of Participants Achieving Meaningful Improvement in EORTC QLQ-C30 Physical Functioning and Fatigue
Time Frame
Day 1 of Cycles 1, 2, 3 and 5 (Cycle length=21 days); TCV/ETTV (up to approximately 32 weeks); post-treatment FU visit (up to approximately 65 months)
Title
Percentage of Participants Achieving Meaningful Improvement in FACT-Lym LymS
Time Frame
Day 1 of Cycles 1, 2, 3 and 5 (Cycle length=21 days); TCV/ETTV (up to approximately 32 weeks); post-treatment FU visit (up to approximately 65 months)
Title
EORTC QLQ-C30 Treatment-Related Symptoms Score
Time Frame
Day 1 of Cycles 1, 2, 3 and 5 (Cycle length=21 days); TCV/ETTV (up to approximately 32 weeks); post-treatment FU visit (up to approximately 65 months)
Title
Functional Assessment of Cancer Treatment/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) Peripheral Neuropathy Score
Time Frame
Day 1 of Cycles 1-8 (Cycle length=21 days); TCV/ETTV (up to approximately 32 weeks); post-treatment FU visit (up to approximately 65 months)
Title
Percentage of Participants With adverse Events (AEs)
Time Frame
From randomization to the end of study (up to approximately 65 months)
Title
Serum Concentration of Total Polatuzumab Vedotin
Time Frame
Pre-infusion (0 hour [hr]), 0.5 hr post-infusion (infusion duration=90 minutes [min]) on Day 1 of Cycle 1 and 4 (Cycle length=21 days); TCV/ETTV (up to approximately 32 weeks); post-treatment FU visit (up to approximately 65 months)
Title
Plasma Concentration of Polatuzumab Vedotin Conjugate (Antibody-Conjugated Mono-Methyl Auristatin E [acMMAE])
Time Frame
0.5 hr post-infusion (infusion duration=90 min) on Day 1 of Cycle 1 and 4 (Cycle length=21 days); TCV/ETTV (up to approximately 32 weeks); post-treatment FU visit (up to approximately 65 months)
Title
Plasma Concentration of Polatuzumab Vedotin Unconjugated MMAE
Time Frame
0.5 hr post-infusion (infusion duration=90 min) on Day 1 of Cycle 1 and 4 (Cycle length=21 days); TCV/ETTV (up to approximately 32 weeks); post-treatment FU visit (up to approximately 65 months)
Title
Percentage of Participants With Anti-Drug Antibody (ADA) to Polatuzumab Vedotin
Time Frame
Pre-infusion (0 hr) on Day 1 of Cycle 1 and 4 (Cycle length=21 days); TCV/ETTV (up to approximately 32 weeks); post-treatment FU visit (up to approximately 65 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Southern Cancer Center
City
Daphne
State/Province
Alabama
ZIP/Postal Code
36526
Country
United States
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Ronald Reagan UCLA Medical Center; Drug Information Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Florida Cancer Specialists - Fort Myers (New Hampshire Ct)
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901-8101
Country
United States
Facility Name
Florida Cancer Specialists & Research Institute
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Florida Cancer Specialists
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Emory University; Investigational Drug Service
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Illinois Cancer Specialists
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
University of Louisville Hospital; The James Graham Brown Cancer Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Ochsner Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana Farber Cancer Institute; Lymphoma Program
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Michigan Health System; UMH Internal Medicine/Hematology-Oncology
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Karmanos Cancer Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
HCA Midwest Division
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Washington University; Wash Uni. Sch. Of Med
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Memorial Sloan Kettering Bergen
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Facility Name
Roswell Park Cancer Institute; Grace Cancer Drug Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center - Commack
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center at Westchester
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
New York University Cancer Cen
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
11101
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Levine Cancer Institute - Clincal Trials Administration
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Ohio State University; B406 Starling-Loving Hall
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Oncology/Hematology Care Clinical Trials LLC
City
Fairfield
State/Province
Ohio
ZIP/Postal Code
45014
Country
United States
Facility Name
Oncology Associates of Oregon, P.C
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Oregon HSU; Bld-Brain Barr/Neuro-Onc
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Northwest Cancer Specialists - Portland (SW Barnes Rd)
City
Tigard
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Fox Chase Cancer Center; Hematology/Oncology
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
University of Pittsburgh Medical Center Cancer Center; Pharmacy
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Medical University of South Carolina Hospital
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Prisma Health ? Upstate
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Tennessee Oncology - Chattanooga; Tennessee Oncology - East Third Street
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Texas Oncology-Austin Midtown
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Rocky Mountain Cancer Centers, LLP
City
Irving
State/Province
Texas
ZIP/Postal Code
75063
Country
United States
Facility Name
Texas Oncology-Tyler
City
Irving
State/Province
Texas
ZIP/Postal Code
75063
Country
United States
Facility Name
Texas Oncology San Antonio Medical Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
University of Utah; Huntsman Cancer Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Oncology Associates of Southwest Virginia, Inc.
City
Blacksburg
State/Province
Virginia
ZIP/Postal Code
24060
Country
United States
Facility Name
Virginia Cancer Specialists, PC
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Shenandoah Oncology Associates
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
Facility Name
Seattle Cancer Care Alliance; Investigational Drug Service
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
North Star Lodge
City
Yakima
State/Province
Washington
ZIP/Postal Code
98902
Country
United States
Facility Name
West Virginia Uni Med. Center - Robert Byrd Health Science
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Concord Repatriation General Hospital
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
St George Hospital
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Prince of Wales Hospital; Haematology
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Calvary Mater Newcastle
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
Westmead Hospital; Outpatient Pharmacy University Clinic
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Ashford Cancer Center Research
City
Kurralta Park
State/Province
South Australia
ZIP/Postal Code
5037
Country
Australia
Facility Name
The University of Adelaide - The Queen Elizabeth Hospital (TQEH)
City
Woodville South
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
Monash Medical Centre
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Austin Hospital; Cancer Clinical Trials Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Medizinische Universitaet Innsbruck - Universitaetsklinik fuer Innere Medizin III
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Landesklinikum Krems
City
Krems
ZIP/Postal Code
3500
Country
Austria
Facility Name
Paracelsus Medizinischen Privatuniversitaet-Salzburger Landeskliniken (SALK)
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Medizinische Universität Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Wiener Gesundheitsverbund ? Klinik Ottakring
City
Wien
ZIP/Postal Code
1160
Country
Austria
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
CH Jolimont - Lobbes (Jolimont)
City
Haine-Saint-Paul
ZIP/Postal Code
7100
Country
Belgium
Facility Name
CHU UCL Mont-Godinne
City
Mont-godinne
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Hospital Erasto Gaertner
City
Curitiba
State/Province
PR
ZIP/Postal Code
81520-060
Country
Brazil
Facility Name
Hospital Sao Vicente de Paulo
City
Passo Fundo
State/Province
RS
ZIP/Postal Code
99010-090
Country
Brazil
Facility Name
Hospital das Clinicas - UFRGS
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Centro de Hematologia e Hemoterapia - HEMOCENTRO UNICAMP
City
Campinas
State/Province
SP
ZIP/Postal Code
13083-878
Country
Brazil
Facility Name
Hospital das Clinicas - FMUSP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-010
Country
Brazil
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
BC Cancer ? Vancouver
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
CancerCare Manitoba (CCMB)
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
MB R3E 0V9
Country
Canada
Facility Name
McMaster University Medical Center, Juravinski Cancer Centre, Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
University Health Network; Princess Margaret Hospital; Medical Oncology Dept
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
CIUSSS de l'Est-de-l'Ile-de-Montréal - Hôpital Maisonneuve-Rosemont
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Centre Hospitalier de l'Universite de Montreal - Pavillon E (PEA)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 1P1
Country
Canada
Facility Name
CHU de Quebec-Universite Laval
City
Quebec
ZIP/Postal Code
G1S 4L8
Country
Canada
Facility Name
Peking Union Medical College Hospital
City
Beijing City
ZIP/Postal Code
100032
Country
China
Facility Name
Beijing Cancer Hospital
City
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
The First Hospital of Jilin University
City
Changchun City
ZIP/Postal Code
130021
Country
China
Facility Name
Fujian Provincial Cancer Hospital
City
Fuzhou City
ZIP/Postal Code
350014
Country
China
Facility Name
Sun Yet-sen University Cancer Center
City
Guangzhou City
ZIP/Postal Code
510663
Country
China
Facility Name
The First Affiliated Hospital of College of Medicine, Zhejiang University
City
Hangzhou
ZIP/Postal Code
310003
Country
China
Facility Name
Jiangsu Cancer Hospital
City
Nanjing City
ZIP/Postal Code
211100
Country
China
Facility Name
Jiangsu Province Hospital
City
Nanjing
ZIP/Postal Code
210008
Country
China
Facility Name
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
City
Shanghai City
ZIP/Postal Code
200025
Country
China
Facility Name
Shanghai East Hospital, Tongji University
City
Shanghai City
ZIP/Postal Code
200032
Country
China
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai City
ZIP/Postal Code
200120
Country
China
Facility Name
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
City
Tianjin City
ZIP/Postal Code
300020
Country
China
Facility Name
Tianjin Medical University Cancer Institute & Hospital
City
Tianjing
ZIP/Postal Code
300060
Country
China
Facility Name
Union Hospital Tongji Medical College Huazhong University of Science and Technology
City
Wuhan City
ZIP/Postal Code
430022
Country
China
Facility Name
Henan Cancer Hospital
City
Zhengzhou
ZIP/Postal Code
450008
Country
China
Facility Name
Fakultni Nemocnice Hradec Kralove (FNHK); IV. Interni Hematologicka Klinika
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Fakultni Nemocnice Kralovske Vinohrady (FNKV); Interni Hematologicka Klinika
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Fakultni nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Fakultni nemocnice Ostrava
City
Ostrava - Poruba
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Univerzita Karlova v Praze 1. Lekarska Fakulta
City
Prague
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
CHU Amiens - Hopital Sud; Hematologie Clinique et Therapie Cellulaire
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
CHU Angers
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
Centre Hospitalier de La Cote Basque; Hematologie
City
Bayonne
ZIP/Postal Code
64109
Country
France
Facility Name
Hopital Jean Minjoz; Hematologie
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Institut d'Hématologie de Basse Normandie
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
CH Metropole de Savoie
City
CHAMBERY Cedex
ZIP/Postal Code
73011
Country
France
Facility Name
Hopital Henri Mondor; Hematologie Clinique
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
CHU de Dijon - Hopital le Bocage
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
L'Union Mutualiste de la Gestion des Eaux Claires - Institut Daniel Hollard
City
Grenoble
ZIP/Postal Code
38000
Country
France
Facility Name
CHD Vendée
City
La Roche Sur Yon
ZIP/Postal Code
85025
Country
France
Facility Name
Hôpital Albert Michallon; Hematologie Clinique
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
Clinique Victor Hugo - Centre Jean Bernard
City
Le Mans Cedex 02
ZIP/Postal Code
72015
Country
France
Facility Name
Hôpital Saint Vincent de Paul
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Hopital Claude Huriez; Hematologie
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hopital Uni Ire Dupuytren; Hematologie
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
CHU Montpellier - Saint ELOI
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
CHU de Nantes - Hotel Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
Facility Name
CHU de Nîmes - Hôpital Carémeau
City
Nimes
ZIP/Postal Code
30029
Country
France
Facility Name
Hôpital Saint-Louis; Service d'Hématologie
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Gh Necker Enfants Malades; Hematologie Clinique
City
Paris
ZIP/Postal Code
75743
Country
France
Facility Name
Hopital Saint Jean; Hematologie
City
Perpignan
ZIP/Postal Code
66046
Country
France
Facility Name
Hopital Haut-Leveque - Centre Francois Magendie; Service d'Hematologie Clinique
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
CHU Lyon Sud - Service Hématologie
City
Pierre Benite
ZIP/Postal Code
69310
Country
France
Facility Name
CHU de Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Centre Hospitalier de Quimper Cornouaille (CHIC); Médecine interne-Maladies du sang
City
Quimper Cedex
ZIP/Postal Code
29107
Country
France
Facility Name
Hopital Pontchaillou; Hematologie Clinique
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Centre Henri Becquerel; Hematologie
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Centre Hospitalier de Saint Brieuc - Hôpital Yves Le Foll
City
St Brieuc
ZIP/Postal Code
22027
Country
France
Facility Name
Pôle de Cancérologie ? CHU de Saint?Etienne'
City
St Priest en Jarez
ZIP/Postal Code
42270
Country
France
Facility Name
CHRU DE STRASBOURG; Département d?Hématologie et Oncologie
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
CHU Bretonneau
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
CHU de Brabois
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
CH Bretagne Atlantique; Médecine interne
City
Vannes Cedex
ZIP/Postal Code
56017
Country
France
Facility Name
Institut Gustave Roussy; Unite D'Hematologie
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Vivantes Klinikum Am Urban
City
Berlin
ZIP/Postal Code
10967
Country
Germany
Facility Name
Städtisches Klinikum Dessau
City
Dessau-Roßlau
ZIP/Postal Code
06847
Country
Germany
Facility Name
Universitätsklinikum Essen
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Universitaetsklinikum Halle (Saale)
City
Halle
ZIP/Postal Code
06120
Country
Germany
Facility Name
Universitaetsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
InVO - Institut für Versorgungsforschung in der Onkologie GbR
City
Koblenz
ZIP/Postal Code
56068
Country
Germany
Facility Name
University of Munich
City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
Universitatsklinikum Munster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Queen Elizabeth Hospital
City
Kowloon
Country
Hong Kong
Facility Name
Azienda Ospedaliera Papa Giovanni XXIII
City
Bergamo
State/Province
Abruzzo
ZIP/Postal Code
24060
Country
Italy
Facility Name
Universita degli Studi Di Brescia - Azienda Ospedaliera Spedali Civili di Brescia
City
Brescia
State/Province
Abruzzo
Country
Italy
Facility Name
Universita degli Studi di Roma ''La Sapienza" - Clinica Ematologica
City
Rome
State/Province
Abruzzo
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Senese
City
Siena
State/Province
Abruzzo
ZIP/Postal Code
53100
Country
Italy
Facility Name
AUSL di Reggio Emilia, IRCCS, P.O. Arcispedale Santa Maria Nuova
City
Reggio Emilia
State/Province
Emilia-Romagna
ZIP/Postal Code
42100
Country
Italy
Facility Name
IRCCS AOU San Martino - IST
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori - s.c. Ematologia
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Facility Name
Istituto Nazionale dei Tumori
City
Monza
State/Province
Lombardia
ZIP/Postal Code
20052
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Maggiore della Carita di Novara
City
Novara
State/Province
Piemonte
ZIP/Postal Code
28100
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino; Ospedale Molinette
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10026
Country
Italy
Facility Name
Aichi Cancer Center
City
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Chiba University Hospital
City
Chiba
ZIP/Postal Code
260-8677
Country
Japan
Facility Name
Chiba Cancer Center
City
Chiba
ZIP/Postal Code
260-8717
Country
Japan
Facility Name
National Cancer Center Hospital East
City
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
National Hospital Organization Kyushu Cancer Center
City
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
Kyushu University Hospital
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Hiroshima University Hospital
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
Hokkaido University Hospital
City
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Kobe City Medical Center General Hospital
City
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
Tokai University Hospital
City
Kanagawa
ZIP/Postal Code
259-1193
Country
Japan
Facility Name
Kumamoto University Hospital
City
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Facility Name
University Hospital Kyoto Prefectural University of Medicine
City
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
Tohoku University Hospital
City
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Osaka Metropolitan University Hospital
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Osaka University Hospital
City
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Kindai University Hospital
City
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Jichi Medical University Hospital
City
Tochigi
ZIP/Postal Code
329-0498
Country
Japan
Facility Name
National Cancer Center Hospital
City
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
The Cancer Institute Hospital of JFCR
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Inje University Busan Paik Hospital
City
Busan
ZIP/Postal Code
47392
Country
Korea, Republic of
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
602-739
Country
Korea, Republic of
Facility Name
National Cancer Center; Medical Oncology
City
Gyeonggi-do
ZIP/Postal Code
410-769
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Pusan National University Yangsan Hospital; hemato-oncology
City
Yangsan
Country
Korea, Republic of
Facility Name
Auckland City Hospital, Cancer and Blood Research
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Canterbury Health Laboratories; Immunology/Rheumatology
City
Christchurch
ZIP/Postal Code
8140
Country
New Zealand
Facility Name
Waikato Hospital
City
Hamilton
ZIP/Postal Code
3248
Country
New Zealand
Facility Name
Palmerston North Hospital
City
Palmerston North
ZIP/Postal Code
4410
Country
New Zealand
Facility Name
Wojewódzki Szpital Specjalistyczny im. M. Kopernika; Klinika Hematologii UM w ?odzi
City
?ód?
ZIP/Postal Code
93-510
Country
Poland
Facility Name
Samodzielny Publiczny Zak?ad Opieki Zdrowotnej Zespó? Szpitali Miejskich w Chorzowie
City
Chorzów
ZIP/Postal Code
41-500
Country
Poland
Facility Name
PRATIA MCM Kraków
City
Kraków
ZIP/Postal Code
30-727
Country
Poland
Facility Name
SPZOZ Ministerstwa Spraw Wewn?trznych i Administracji w Poznaniu; Oddzia? Hematologii
City
Pozna?
ZIP/Postal Code
60-631
Country
Poland
Facility Name
Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy
City
Warszawa
ZIP/Postal Code
04-141
Country
Poland
Facility Name
Leningrad Regional Clinical Hospital
City
St Petersburg
State/Province
Sankt Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
City
Kazan
State/Province
Tatarstan
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
Penza Regional Oncology Dispensary
City
Penza
ZIP/Postal Code
440071
Country
Russian Federation
Facility Name
Institut Catala d Oncologia Hospitalet
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro - Majadahonda
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28220
Country
Spain
Facility Name
Complejo Hospitalario de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital San Pedro de Alcantara
City
Caceres
ZIP/Postal Code
10003
Country
Spain
Facility Name
Hospital Universitari Dr. Josep Trueta
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
280146
Country
Spain
Facility Name
Hospital Quiron Madrid
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Facility Name
Fundación Jimenez Díaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario Virgen de la Victoria
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hirslanden Medical Center - Tumorzentrum
City
Aarau
ZIP/Postal Code
5000
Country
Switzerland
Facility Name
Universitätsspital Basel Gynäkologie - Onkologie
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Hopital Cantonal Universitaire De Geneve
City
Genève
ZIP/Postal Code
1211
Country
Switzerland
Facility Name
Kaohsiung Medical University Hospital, Cancer Center
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
China Medical University Hospital; Clinical Research Center Clinical Pharmacy
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Chi-Mei Hospital, Liouying
City
Tainan
ZIP/Postal Code
736
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei City
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Ankara University Faculty of Medicine Cebeci Hospital
City
Ankara
ZIP/Postal Code
06700
Country
Turkey
Facility Name
Ege Üniversitesi Tip Fakültesi
City
Lzmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Dokuz Eylul Universitesi Tip Fakultesi
City
Lzmir
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Vehbi Koc Vakfi (VKV) - Amerikan Hastanesi
City
Te?v?k?ye
ZIP/Postal Code
34365
Country
Turkey
Facility Name
Communal Institution 'Cherkassy Regional Oncology Dispensary' of the Cherkassy Regional Council
City
Cherkassy
State/Province
Chernihiv Governorate
Country
Ukraine
Facility Name
MNE Lviv Territorial Medical Association Clinical Hospital for Palliative Care
City
Lviv
State/Province
Chernihiv Governorate
ZIP/Postal Code
79007
Country
Ukraine
Facility Name
Khmelnytskyi Regional Hospital; Department of Hemathology
City
Khmelnytskyi
State/Province
Kharkiv Governorate
ZIP/Postal Code
29000
Country
Ukraine
Facility Name
Feofaniya Center of Haematology and Chemotherapy of Haemoblastosis
City
Kyiv
State/Province
Volhynian Governorate
ZIP/Postal Code
03143
Country
Ukraine
Facility Name
Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
East Kent Hospitals University NHS Foundation Trust
City
Canterbury
ZIP/Postal Code
CT1 3NG
Country
United Kingdom
Facility Name
University Hospitals of Leicester NHS Trust - Leicester Royal Infirmary
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Barts Health NHS Trust; Bartholomew's H., King George V Building
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
The Newcastle upon Tyne Hospitals NHS Foundation Trust. Freeman Hospital
City
Newcastle upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Nottingham City Hospital; Dept of Haematology
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Oxford University Hospitals NHS Foundation Trust
City
Oxford
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Facility Name
University Hospital Southampton NHS Foundation Trust
City
Southhampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
35726803
Citation
Varma G, Wang J, Diefenbach C. Polatuzumab vedotin in relapsed / refractory aggressive B-cell lymphoma. Expert Rev Anticancer Ther. 2022 Aug;22(8):795-803. doi: 10.1080/14737140.2022.2093191. Epub 2022 Jun 27.
Results Reference
derived
PubMed Identifier
34904799
Citation
Tilly H, Morschhauser F, Sehn LH, Friedberg JW, Trneny M, Sharman JP, Herbaux C, Burke JM, Matasar M, Rai S, Izutsu K, Mehta-Shah N, Oberic L, Chauchet A, Jurczak W, Song Y, Greil R, Mykhalska L, Bergua-Burgues JM, Cheung MC, Pinto A, Shin HJ, Hapgood G, Munhoz E, Abrisqueta P, Gau JP, Hirata J, Jiang Y, Yan M, Lee C, Flowers CR, Salles G. Polatuzumab Vedotin in Previously Untreated Diffuse Large B-Cell Lymphoma. N Engl J Med. 2022 Jan 27;386(4):351-363. doi: 10.1056/NEJMoa2115304. Epub 2021 Dec 14.
Results Reference
derived
Learn more about this trial
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
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