Clinical trial NCT03274492: 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
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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Diffuse Large B-Cell Lymphoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2017-09-07
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Progression-Free Survival (PFS) as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma
timeFrame: From randomization to the first occurrence of disease progression or relapse, or death from any cause, whichever occurs earlier (up to 38 months)
Secondary outcomes:
measure: Percentage of Participants With Complete Response (CR) as Assessed by Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) by Blinded Independent Central Review (BICR)
timeFrame: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 8 [Cycle length=21 days] [up to Week 32])
measure: Event-Free Survival-Efficacy (EFSeff) as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma
timeFrame: 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)
measure: Percentage of Participants Who are Progression Free as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma
timeFrame: 24 months after enrollment (up to approximately 65 months)
measure: Overall Survival
timeFrame: From randomization until death from any cause (up to approximately 65 months)
measure: Percentage of Participants With CR as Assessed by FDG-PET by Investigator
timeFrame: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 8 [Cycle length=21 days] [up to Week 32])
measure: Disease-Free Survival (DFS) as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma
timeFrame: 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)
measure: Duration of Response as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma
timeFrame: 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)
measure: Event-Free Survival-All Causes (EFSall) as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma
timeFrame: From randomization to disease progression or relapse, or death from any cause, or initiation of any NALT (up to approximately 65 months)
measure: 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
timeFrame: 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)
measure: Time to Deterioration in Functional Assessment of Cancer Therapy-Lymphoma Lymphoma Subscale (FACT-Lym LymS)
timeFrame: 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)
measure: Percentage of Participants Achieving Meaningful Improvement in EORTC QLQ-C30 Physical Functioning and Fatigue
timeFrame: 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)
measure: Percentage of Participants Achieving Meaningful Improvement in FACT-Lym LymS
timeFrame: 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)
measure: EORTC QLQ-C30 Treatment-Related Symptoms Score
timeFrame: 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)
measure: Functional Assessment of Cancer Treatment/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) Peripheral Neuropathy Score
timeFrame: 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)
measure: Percentage of Participants With adverse Events (AEs)
timeFrame: From randomization to the end of study (up to approximately 65 months)
measure: Serum Concentration of Total Polatuzumab Vedotin
timeFrame: 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)
measure: Plasma Concentration of Polatuzumab Vedotin Conjugate (Antibody-Conjugated Mono-Methyl Auristatin E [acMMAE])
timeFrame: 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)
measure: Plasma Concentration of Polatuzumab Vedotin Unconjugated MMAE
timeFrame: 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)
measure: Percentage of Participants With Anti-Drug Antibody (ADA) to Polatuzumab Vedotin
timeFrame: 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)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Daphne
country: United States
facility: Southern Cancer Center
state: Alabama
city: Duarte
country: United States
facility: City of Hope
state: California
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
city: Aurora
country: United States
facility: Rocky Mountain Cancer Centers, LLP
state: Colorado
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Fort Myers
country: United States
facility: Florida Cancer Specialists - Fort Myers (New Hampshire Ct)
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists & Research Institute
state: Florida
city: West Palm Beach
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Arlington Heights
country: United States
facility: Illinois Cancer Specialists
state: Illinois
city: Louisville
country: United States
facility: University of Louisville Hospital
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Detroit
country: United States
facility: Karmanos Cancer Center
state: Michigan
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen
state: New Jersey
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center - Commack
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Cancer Center at Westchester
state: New York
city: New York
country: United States
facility: New York University Cancer Cen
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: Levine Cancer Institute - Clincal Trials Administration
state: North Carolina
city: Cincinnati
country: United States
facility: Oncology/Hematology Care Clinical Trials LLC
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Eugene
country: United States
facility: Oncology Associates of Oregon, P.C
state: Oregon
city: Portland
country: United States
facility: Northwest Cancer Specialists - Portland (SW Barnes Rd)
state: Oregon
city: Portland
country: United States
facility: Oregon HSU
state: Oregon
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center Cancer Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina Hospital
state: South Carolina
city: Greenville
country: United States
facility: Prisma Health ? Upstate
state: South Carolina
city: Chattanooga
country: United States
facility: Greco-Hainesworth Centers for Research
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology - Nashville
state: Tennessee
city: Austin
country: United States
facility: Texas Oncology-Austin Midtown
state: Texas
city: San Antonio
country: United States
facility: Texas Oncology San Antonio Medical Center
state: Texas
city: Tyler
country: United States
facility: Texas Oncology-Tyler
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Blacksburg
country: United States
facility: Oncology Associates of Southwest Virginia, Inc.
state: Virginia
city: Fairfax
country: United States
facility: Virginia Cancer Specialists, PC
state: Virginia
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Morgantown
country: United States
facility: West Virginia Uni Med. Center - Robert Byrd Health Science
state: West Virginia
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
state: New South Wales
city: Kigarah
country: Australia
facility: St George Hospital
state: New South Wales
city: Randwick
country: Australia
facility: Prince of Wales Hospital
state: New South Wales
city: Waratah
country: Australia
facility: Calvary Mater Newcastle
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital Woolloongabba
state: Queensland
city: Kurralta Park
country: Australia
facility: Ashford Cancer Center Research
state: South Australia
city: Woodville South
country: Australia
facility: The University of Adelaide - The Queen Elizabeth Hospital (TQEH)
state: South Australia
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Hospital
state: Victoria
city: Salzburg
country: Austria
facility: Paracelsus Medizinischen Privatuniversitaet-Salzburger Landeskliniken (SALK)
city: Wien
country: Austria
facility: Medizinische Universität Wien
city: Wien
country: Austria
facility: Wiener Gesundheitsverbund ? Klinik Ottakring
city: Gent
country: Belgium
facility: UZ Gent
city: Haine-Saint-Paul
country: Belgium
facility: CH Jolimont - Lobbes (Jolimont)
city: Mont-godinne
country: Belgium
facility: CHU UCL Mont-Godinne
city: Curitiba
country: Brazil
facility: Hospital Erasto Gaertner
state: Paraná
city: Porto Alegre
country: Brazil
facility: Hospital das Clinicas - UFRGS
state: Rio Grande Do Sul
city: Campinas
country: Brazil
facility: Centro de Hematologia e Hemoterapia - HEMOCENTRO UNICAMP
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas - FMUSP
state: São Paulo
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Vancouver
country: Canada
facility: BC Cancer ? Vancouver
state: British Columbia
city: Winnipeg
country: Canada
facility: CancerCare Manitoba (CCMB)
state: Manitoba
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Montreal
country: Canada
facility: CIUSSS de l Est de l Ile de Montreal - Hopital Maisonneuve Rosemont
state: Quebec
city: Quebec
country: Canada
facility: CHU de Quebec-Universite Laval
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Changchun City
country: China
facility: The First Hospital of Jilin University
city: Fuzhou City
country: China
facility: Fujian Provincial Cancer Hospital
city: Guangzhou
country: China
facility: Sun Yet-sen University Cancer Center
city: Hangzhou
country: China
facility: The First Affiliated Hospital of College of Medicine, Zhejiang University
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital
city: Shanghai City
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine
city: Shanghai City
country: China
facility: Shanghai East Hospital, Tongji University
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Tianjin City
country: China
facility: Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
city: Tianjing
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
city: Wuhan City
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
city: Hradec Kralove
country: Czechia
facility: Fakultni Nemocnice Hradec Kralove (FNHK)
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Ostrava - Poruba
country: Czechia
facility: Fakultni nemocnice Ostrava
city: Prague
country: Czechia
facility: Fakultni Nemocnice Kralovske Vinohrady (FNKV)
city: Prague
country: Czechia
facility: Univerzita Karlova v Praze 1. Lekarska Fakulta
city: Amiens
country: France
facility: CHU Amiens - Hopital Sud
city: Angers
country: France
facility: CHU Angers
city: Bayonne
country: France
facility: Centre Hospitalier de La Cote Basque
city: Besancon
country: France
facility: Hopital Jean Minjoz
city: Bordeaux
country: France
facility: Institut Bergonie
city: Caen
country: France
facility: Institut d'Hématologie de Basse Normandie
city: CHAMBERY Cedex
country: France
facility: CH Metropole de Savoie
city: Creteil
country: France
facility: Hopital Henri Mondor
city: Dijon
country: France
facility: CHU de Dijon - Hopital le Bocage
city: Grenoble
country: France
facility: L'Union Mutualiste de la Gestion des Eaux Claires - Institut Daniel Hollard
city: La Roche Sur Yon
country: France
facility: CHD Vendée
city: La Tronche
country: France
facility: Hôpital Albert Michallon
city: Le Mans Cedex 02
country: France
facility: Clinique Victor Hugo - Centre Jean Bernard
city: Lille
country: France
facility: Hôpital Saint Vincent de Paul
city: Lille
country: France
facility: Hopital Claude Huriez
city: Limoges
country: France
facility: Hopital Uni Ire Dupuytren
city: Lyon
country: France
facility: Centre Leon Berard
city: Montpellier
country: France
facility: CHU Montpellier - Saint ELOI
city: Nantes
country: France
facility: CHU de Nantes - Hotel Dieu
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Nimes
country: France
facility: CHU de Nîmes - Hôpital Carémeau
city: Paris
country: France
facility: Hôpital Saint-Louis
city: Paris
country: France
facility: Gh Necker Enfants Malades
city: Perpignan
country: France
facility: Hopital Saint Jean
city: Pessac
country: France
facility: Hopital Haut-Leveque - Centre Francois Magendie
city: Pierre Benite
country: France
facility: CHU Lyon Sud - Service Hématologie
city: Poitiers
country: France
facility: CHU de Poitiers
city: Quimper Cedex
country: France
facility: Centre Hospitalier de Quimper Cornouaille (CHIC)
city: Rennes
country: France
facility: Hopital Pontchaillou
city: Rouen
country: France
facility: Centre Henri Becquerel
city: St Brieuc
country: France
facility: Centre Hospitalier de Saint Brieuc - Hôpital Yves Le Foll
city: St Priest en Jarez
country: France
facility: Pôle de Cancérologie ? CHU de Saint?Etienne'
city: Strasbourg
country: France
facility: Chru de Strasbourg
city: Toulouse
country: France
facility: Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)
city: Tours
country: France
facility: CHU Bretonneau
city: Vandoeuvre Les Nancy
country: France
facility: CHU de Brabois
city: Vannes Cedex
country: France
facility: CH Bretagne Atlantique
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Berlin
country: Germany
facility: Vivantes Klinikum Am Urban
city: Dessau-Roßlau
country: Germany
facility: Städtisches Klinikum Dessau
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Halle
country: Germany
facility: Universitaetsklinikum Halle (Saale)
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg
city: Koblenz
country: Germany
facility: InVO - Institut für Versorgungsforschung in der Onkologie GbR
city: Münster
country: Germany
facility: Universitatsklinikum Munster
city: Bergamo
country: Italy
facility: Azienda Ospedaliera Papa Giovanni XXIII
state: Abruzzo
city: Brescia
country: Italy
facility: Universita degli Studi Di Brescia - Azienda Ospedaliera Spedali Civili di Brescia
state: Abruzzo
city: Rome
country: Italy
facility: Universita degli Studi di Roma ''La Sapienza" - Clinica Ematologica
state: Abruzzo
city: Reggio Emilia
country: Italy
facility: AUSL di Reggio Emilia, IRCCS, P.O. Arcispedale Santa Maria Nuova
state: Emilia-Romagna
city: Genova
country: Italy
facility: IRCCS AOU San Martino - IST
state: Liguria
city: Monza
country: Italy
facility: Istituto Nazionale dei Tumori
state: Lombardia
city: Novara
country: Italy
facility: Azienda Ospedaliero Universitaria Maggiore della Carita di Novara
state: Piemonte
city: Torino
country: Italy
facility: Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino
state: Piemonte
city: Aichi
country: Japan
facility: Aichi Cancer Center
city: Chiba
country: Japan
facility: Chiba Cancer Center
city: Chiba
country: Japan
facility: National Cancer Center Hospital East
city: Chuo-ku
country: Japan
facility: Chiba University Hospital
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital
city: Hokkaido
country: Japan
facility: Hokkaido University Hospital
city: Hyogo
country: Japan
facility: Kobe City Medical Center General Hospital
city: Isehara-shi
country: Japan
facility: Tokai University Hospital
city: Kumamoto
country: Japan
facility: Kumamoto University Hospital
city: Kyoto
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine
city: Miyagi
country: Japan
facility: Tohoku University Hospital
city: Osaka
country: Japan
facility: Osaka Metropolitan University Hospital
city: Osaka
country: Japan
facility: Osaka University Hospital
city: Osaka
country: Japan
facility: Kindai University Hospital
city: Tochigi
country: Japan
facility: Jichi Medical University Hospital
city: Tokyo
country: Japan
facility: National Cancer Center Hospital
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: National Cancer Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Auckland
country: New Zealand
facility: Auckland City Hospital, Cancer and Blood Research
city: Christchurch
country: New Zealand
facility: Canterbury Health Laboratories
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: ?ód?
country: Poland
facility: Wojewódzki Szpital Specjalistyczny im. M. Kopernika
city: Chorzów
country: Poland
facility: Samodzielny Publiczny Zak?ad Opieki Zdrowotnej Zespó? Szpitali Miejskich w Chorzowie
city: Kraków
country: Poland
facility: PRATIA MCM Kraków
city: Pozna?
country: Poland
facility: SPZOZ Ministerstwa Spraw Wewn?trznych i Administracji w Poznaniu
city: Warszawa
country: Poland
facility: Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy
city: St Petersburg
country: Russian Federation
facility: Leningrad Regional Clinical Hospital
state: Sankt Petersburg
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
state: Navarra
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Institut Catala d Oncologia Hospitalet
city: Caceres
country: Spain
facility: Hospital San Pedro de Alcantara
city: Girona
country: Spain
facility: Hospital Universitari Dr. Josep Trueta
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Fundación Jimenez Díaz
city: Madrid
country: Spain
facility: Hospital Quiron Madrid
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Basel
country: Switzerland
facility: Universitätsspital Basel Gynäkologie - Onkologie
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital, Cancer Center
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: Chi-Mei Hospital, Liouying
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Ankara
country: Turkey
facility: Ankara University Faculty of Medicine Cebeci Hospital
city: Lzmir
country: Turkey
facility: Ege Üniversitesi Tip Fakültesi
city: Lzmir
country: Turkey
facility: Dokuz Eylul Universitesi Tip Fakultesi
city: Cherkassy
country: Ukraine
facility: Communal Institution 'Cherkassy Regional Oncology Dispensary' of the Cherkassy Regional Council
state: Chernihiv Governorate
city: Lviv
country: Ukraine
facility: MNE Lviv Territorial Medical Association Clinical Hospital for Palliative Care
state: Chernihiv Governorate
city: Khmelnytskyi
country: Ukraine
facility: Khmelnytskyi Regional Hospital
state: Kharkiv Governorate
city: Kyiv
country: Ukraine
facility: Feofaniya Center of Haematology and Chemotherapy of Haemoblastosis
state: Volhynian Governorate
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital
city: Canterbury
country: United Kingdom
facility: East Kent Hospitals University NHS Foundation Trust
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester NHS Trust - Leicester Royal Infirmary
city: London
country: United Kingdom
facility: Barts Health NHS Trust
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
city: Newcastle upon Tyne
country: United Kingdom
facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust. Freeman Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
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.
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.