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

Diffuse Large B-Cell Lymphoma Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03274492
• Other study ID #: GO39942
• Secondary ID: 2017-002023-21
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 16, 2017
• Est. completion date: June 27, 2024

Study information

• Verified date: April 2024
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: June 27, 2024
• Est. primary completion date: June 27, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diffuse Large B-Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• Polatuzumab Vedotin
Polatuzumab vedotin IV infusion will be administered as per the schedule specified in the respective arm.
• Rituximab
Rituximab IV infusion will be administered as per the schedule specified in the respective arm.
• Cyclophosphamide
Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.
• Doxorubicin
Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.
• Vincristine
Vincristine IV infusion will be administered as per the schedule specified in the respective arm.
• Vincristine Placebo
Placebo matching to vincristine will be administered as per the schedule specified in the respective arm.
• Prednisone
Prednisone PO will be administered as per the schedule specified in the respective arm.
• Polatuzumab vedotin Placebo
Placebo matching to polatuzumab vedotin will be administered as per the schedule specified in the respective arm.

Locations

Country	Name	City	State
Australia	Monash Medical Centre	Clayton	Victoria
Australia	Concord Repatriation General Hospital	Concord	New South Wales
Australia	St George Hospital	Kogarah	New South Wales
Australia	Ashford Cancer Center Research	Kurralta Park	South Australia
Australia	Austin Hospital; Cancer Clinical Trials Centre	Melbourne	Victoria
Australia	Prince of Wales Hospital; Haematology	Randwick	New South Wales
Australia	Calvary Mater Newcastle	Waratah	New South Wales
Australia	Westmead Hospital; Outpatient Pharmacy University Clinic	Westmead	New South Wales
Australia	The University of Adelaide - The Queen Elizabeth Hospital (TQEH)	Woodville South	South Australia
Australia	Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology	Woolloongabba	Queensland
Austria	Medizinische Universitaet Innsbruck - Universitaetsklinik fuer Innere Medizin III	Innsbruck
Austria	Landesklinikum Krems	Krems
Austria	Paracelsus Medizinischen Privatuniversitaet-Salzburger Landeskliniken (SALK)	Salzburg
Austria	Medizinische Universität Wien	Wien
Austria	Wiener Gesundheitsverbund ? Klinik Ottakring	Wien
Belgium	UZ Gent	Gent
Belgium	CH Jolimont - Lobbes (Jolimont)	Haine-Saint-Paul
Belgium	CHU UCL Mont-Godinne	Mont-godinne
Brazil	Centro de Hematologia e Hemoterapia - HEMOCENTRO UNICAMP	Campinas	SP
Brazil	Hospital Erasto Gaertner	Curitiba	PR
Brazil	Hospital Sao Vicente de Paulo	Passo Fundo	RS
Brazil	Hospital das Clinicas - UFRGS	Porto Alegre	RS
Brazil	Hospital das Clinicas - FMUSP	Sao Paulo	SP
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	McMaster University Medical Center, Juravinski Cancer Centre, Hamilton Health Sciences	Hamilton	Ontario
Canada	Centre Hospitalier de l'Universite de Montreal - Pavillon E (PEA)	Montreal	Quebec
Canada	CIUSSS de l Est de l Ile de Montreal - Hopital Maisonneuve Rosemont	Montreal	Quebec
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	CHU de Quebec-Universite Laval	Quebec
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	University Health Network; Princess Margaret Hospital; Medical Oncology Dept	Toronto	Ontario
Canada	BC Cancer ? Vancouver	Vancouver	British Columbia
Canada	CancerCare Manitoba (CCMB)	Winnipeg	Manitoba
China	Beijing Cancer Hospital	Beijing
China	Peking Union Medical College Hospital	Beijing City
China	The First Hospital of Jilin University	Changchun City
China	Fujian Provincial Cancer Hospital	Fuzhou City
China	Sun Yet-sen University Cancer Center	Guangzhou City
China	The First Affiliated Hospital of College of Medicine, Zhejiang University	Hangzhou
China	Jiangsu Province Hospital	Nanjing
China	Jiangsu Cancer Hospital	Nanjing City
China	Fudan University Shanghai Cancer Center	Shanghai City
China	Ruijin Hospital, Shanghai Jiaotong University School of Medicine	Shanghai City
China	Shanghai East Hospital, Tongji University	Shanghai City
China	Tianjin Medical University Cancer Institute & Hospital	Tianjin
China	Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences	Tianjin City
China	Union Hospital Tongji Medical College Huazhong University of Science and Technology	Wuhan City
China	Henan Cancer Hospital	Zhengzhou
Czechia	Fakultni Nemocnice Hradec Kralove (FNHK); IV. Interni Hematologicka Klinika	Hradec Kralove
Czechia	Fakultni Nemocnice Kralovske Vinohrady (FNKV); Interni Hematologicka Klinika	Hradec Kralove
Czechia	Fakultni nemocnice Olomouc	Olomouc
Czechia	Fakultni nemocnice Ostrava	Ostrava - Poruba
Czechia	Univerzita Karlova v Praze 1. Lekarska Fakulta	Prague
France	CHU Amiens - Hopital Sud; Hematologie Clinique et Therapie Cellulaire	Amiens
France	CHU Angers	Angers
France	Centre Hospitalier de La Cote Basque; Hematologie	Bayonne
France	Hopital Jean Minjoz; Hematologie	Besancon
France	Institut Bergonie	Bordeaux
France	Institut d'Hématologie de Basse Normandie	Caen
France	CH Metropole de Savoie	CHAMBERY Cedex
France	Hopital Henri Mondor; Hematologie Clinique	Creteil
France	CHU de Dijon - Hopital le Bocage	Dijon
France	L'Union Mutualiste de la Gestion des Eaux Claires - Institut Daniel Hollard	Grenoble
France	CHD Vendée	La Roche Sur Yon
France	Hôpital Albert Michallon; Hematologie Clinique	La Tronche
France	Clinique Victor Hugo - Centre Jean Bernard	Le Mans Cedex 02
France	Hopital Claude Huriez; Hematologie	Lille
France	Hôpital Saint Vincent de Paul	Lille
France	Hopital Uni Ire Dupuytren; Hematologie	Limoges
France	Centre Leon Berard	Lyon
France	CHU Montpellier - Saint ELOI	Montpellier
France	CHU de Nantes - Hotel Dieu	Nantes
France	Centre Antoine Lacassagne	Nice
France	CHU de Nîmes - Hôpital Carémeau	Nimes
France	Gh Necker Enfants Malades; Hematologie Clinique	Paris
France	Hôpital Saint-Louis; Service d'Hématologie	Paris
France	Hopital Saint Jean; Hematologie	Perpignan
France	Hopital Haut-Leveque - Centre Francois Magendie; Service d'Hematologie Clinique	Pessac
France	CHU Lyon Sud - Service Hématologie	Pierre Benite
France	CHU de Poitiers	Poitiers
France	Centre Hospitalier de Quimper Cornouaille (CHIC); Médecine interne-Maladies du sang	Quimper Cedex
France	Hopital Pontchaillou; Hematologie Clinique	Rennes
France	Centre Henri Becquerel; Hematologie	Rouen
France	Centre Hospitalier de Saint Brieuc - Hôpital Yves Le Foll	St Brieuc
France	Pôle de Cancérologie ? CHU de Saint?Etienne'	St Priest en Jarez
France	CHRU DE STRASBOURG; Département d?Hématologie et Oncologie	Strasbourg
France	Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)	Toulouse
France	CHU Bretonneau	Tours
France	CHU de Brabois	Vandoeuvre Les Nancy
France	CH Bretagne Atlantique; Médecine interne	Vannes Cedex
France	Institut Gustave Roussy; Unite D'Hematologie	Villejuif
Germany	Vivantes Klinikum Am Urban	Berlin
Germany	Städtisches Klinikum Dessau	Dessau-Roßlau
Germany	Universitätsklinikum Essen	Essen
Germany	Universitaetsklinikum Halle (Saale)	Halle
Germany	Universitaetsklinikum Heidelberg	Heidelberg
Germany	InVO - Institut für Versorgungsforschung in der Onkologie GbR	Koblenz
Germany	University of Munich	München
Germany	Universitatsklinikum Munster	Münster
Hong Kong	Queen Mary Hospital	Hong Kong
Hong Kong	Queen Elizabeth Hospital	Kowloon
Italy	Azienda Ospedaliera Papa Giovanni XXIII	Bergamo	Abruzzo
Italy	Universita degli Studi Di Brescia - Azienda Ospedaliera Spedali Civili di Brescia	Brescia	Abruzzo
Italy	IRCCS AOU San Martino - IST	Genova	Liguria
Italy	Fondazione IRCCS Istituto Nazionale dei Tumori - s.c. Ematologia	Milano	Lombardia
Italy	Istituto Nazionale dei Tumori	Monza	Lombardia
Italy	Azienda Ospedaliero Universitaria Maggiore della Carita di Novara	Novara	Piemonte
Italy	AUSL di Reggio Emilia, IRCCS, P.O. Arcispedale Santa Maria Nuova	Reggio Emilia	Emilia-Romagna
Italy	Universita degli Studi di Roma ''La Sapienza" - Clinica Ematologica	Rome	Abruzzo
Italy	Azienda Ospedaliera Universitaria Senese	Siena	Abruzzo
Italy	Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino; Ospedale Molinette	Torino	Piemonte
Japan	Aichi Cancer Center	Aichi
Japan	Chiba Cancer Center	Chiba
Japan	Chiba University Hospital	Chiba
Japan	National Cancer Center Hospital East	Chiba
Japan	Kyushu University Hospital	Fukuoka
Japan	National Hospital Organization Kyushu Cancer Center	Fukuoka
Japan	Hiroshima University Hospital	Hiroshima
Japan	Hokkaido University Hospital	Hokkaido
Japan	Kobe City Medical Center General Hospital	Hyogo
Japan	Tokai University Hospital	Kanagawa
Japan	Kumamoto University Hospital	Kumamoto
Japan	University Hospital Kyoto Prefectural University of Medicine	Kyoto
Japan	Tohoku University Hospital	Miyagi
Japan	Kindai University Hospital	Osaka
Japan	Osaka Metropolitan University Hospital	Osaka
Japan	Osaka University Hospital	Osaka
Japan	Jichi Medical University Hospital	Tochigi
Japan	National Cancer Center Hospital	Tokyo
Japan	The Cancer Institute Hospital of JFCR	Tokyo
Korea, Republic of	Inje University Busan Paik Hospital	Busan
Korea, Republic of	Pusan National University Hospital	Busan
Korea, Republic of	National Cancer Center; Medical Oncology	Gyeonggi-do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	Pusan National University Yangsan Hospital; hemato-oncology	Yangsan
New Zealand	Auckland City Hospital, Cancer and Blood Research	Auckland
New Zealand	Canterbury Health Laboratories; Immunology/Rheumatology	Christchurch
New Zealand	Waikato Hospital	Hamilton
New Zealand	Palmerston North Hospital	Palmerston North
Poland	Wojewódzki Szpital Specjalistyczny im. M. Kopernika; Klinika Hematologii UM w ?odzi	?ód?
Poland	Samodzielny Publiczny Zak?ad Opieki Zdrowotnej Zespó? Szpitali Miejskich w Chorzowie	Chorzów
Poland	PRATIA MCM Kraków	Kraków
Poland	SPZOZ Ministerstwa Spraw Wewn?trznych i Administracji w Poznaniu; Oddzia? Hematologii	Pozna?
Poland	Centrum Onkologii-Instytut im. M. Sklodowskiej Curie	Warszawa
Poland	Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy	Warszawa
Russian Federation	Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic	Kazan	Tatarstan
Russian Federation	Penza Regional Oncology Dispensary	Penza
Russian Federation	Leningrad Regional Clinical Hospital	St Petersburg	Sankt Petersburg
Spain	Hospital Clinic Barcelona	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital San Pedro de Alcantara	Caceres
Spain	Hospital Universitari Dr. Josep Trueta	Girona
Spain	Institut Catala d Oncologia Hospitalet	Hospitalet de Llobregat	Barcelona
Spain	Fundación Jimenez Díaz	Madrid
Spain	Hospital Quiron Madrid	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Puerta de Hierro - Majadahonda	Majadahonda	Madrid
Spain	Hospital Universitario Virgen de la Victoria	Malaga
Spain	Complejo Hospitalario de Navarra	Pamplona	Navarra
Spain	Hospital Universitario Virgen del Rocio	Sevilla
Switzerland	Hirslanden Medical Center - Tumorzentrum	Aarau
Switzerland	Universitätsspital Basel Gynäkologie - Onkologie	Basel
Switzerland	Hopital Cantonal Universitaire De Geneve	Genève
Taiwan	Kaohsiung Medical University Hospital, Cancer Center	Kaohsiung
Taiwan	China Medical University Hospital; Clinical Research Center Clinical Pharmacy	Taichung
Taiwan	Chi-Mei Hospital, Liouying	Tainan
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei City
Turkey	Ankara University Faculty of Medicine Cebeci Hospital	Ankara
Turkey	Dokuz Eylul Universitesi Tip Fakultesi	Lzmir
Turkey	Ege Üniversitesi Tip Fakültesi	Lzmir
Turkey	Vehbi Koc Vakfi (VKV) - Amerikan Hastanesi	Te?v?k?ye
Ukraine	Communal Institution 'Cherkassy Regional Oncology Dispensary' of the Cherkassy Regional Council	Cherkassy	Chernihiv Governorate
Ukraine	Khmelnytskyi Regional Hospital; Department of Hemathology	Khmelnytskyi	Kharkiv Governorate
Ukraine	Feofaniya Center of Haematology and Chemotherapy of Haemoblastosis	Kyiv	Volhynian Governorate
Ukraine	MNE Lviv Territorial Medical Association Clinical Hospital for Palliative Care	Lviv	Chernihiv Governorate
United Kingdom	Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital	Cambridge
United Kingdom	East Kent Hospitals University NHS Foundation Trust	Canterbury
United Kingdom	University Hospitals of Leicester NHS Trust - Leicester Royal Infirmary	Leicester
United Kingdom	Barts Health NHS Trust; Bartholomew's H., King George V Building	London
United Kingdom	The Christie NHS Foundation Trust	Manchester
United Kingdom	The Newcastle upon Tyne Hospitals NHS Foundation Trust. Freeman Hospital	Newcastle upon Tyne
United Kingdom	Nottingham City Hospital; Dept of Haematology	Nottingham
United Kingdom	Oxford University Hospitals NHS Foundation Trust	Oxford
United Kingdom	University Hospital Southampton NHS Foundation Trust	Southhampton
United States	University of Michigan Health System; UMH Internal Medicine/Hematology-Oncology	Ann Arbor	Michigan
United States	Illinois Cancer Specialists	Arlington Heights	Illinois
United States	Emory University; Investigational Drug Service	Atlanta	Georgia
United States	Texas Oncology-Austin Midtown	Austin	Texas
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Maryland	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Oncology Associates of Southwest Virginia, Inc.	Blacksburg	Virginia
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana Farber Cancer Institute; Lymphoma Program	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Roswell Park Cancer Institute; Grace Cancer Drug Center	Buffalo	New York
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Medical University of South Carolina Hospital	Charleston	South Carolina
United States	Levine Cancer Institute - Clincal Trials Administration	Charlotte	North Carolina
United States	Greco-Hainesworth Centers for Research; ETN (East Tennessee)	Chattanooga	Tennessee
United States	University Hospitals Case Medical Center	Cleveland	Ohio
United States	Ohio State University; B406 Starling-Loving Hall	Columbus	Ohio
United States	Memorial Sloan Kettering Cancer Center - Commack	Commack	New York
United States	Southern Cancer Center	Daphne	Alabama
United States	Karmanos Cancer Center	Detroit	Michigan
United States	City of Hope	Duarte	California
United States	Oncology Associates of Oregon, P.C	Eugene	Oregon
United States	Virginia Cancer Specialists, PC	Fairfax	Virginia
United States	Oncology/Hematology Care Clinical Trials LLC	Fairfield	Ohio
United States	Florida Cancer Specialists - Fort Myers (New Hampshire Ct)	Fort Myers	Florida
United States	Prisma Health ? Upstate	Greenville	South Carolina
United States	Memorial Sloan Kettering Cancer Center at Westchester	Harrison	New York
United States	Rocky Mountain Cancer Centers, LLP	Irving	Texas
United States	Texas Oncology-Tyler	Irving	Texas
United States	HCA Midwest Division	Kansas City	Missouri
United States	Ronald Reagan UCLA Medical Center; Drug Information Center	Los Angeles	California
United States	University of Louisville Hospital; The James Graham Brown Cancer Center	Louisville	Kentucky
United States	Memorial Sloan Kettering Bergen	Montvale	New Jersey
United States	West Virginia Uni Med. Center - Robert Byrd Health Science	Morgantown	West Virginia
United States	SCRI Oncology Partners	Nashville	Tennessee
United States	Ochsner Medical Center	New Orleans	Louisiana
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	New York University Cancer Cen	New York	New York
United States	Fox Chase Cancer Center; Hematology/Oncology	Philadelphia	Pennsylvania
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center Cancer Center; Pharmacy	Pittsburgh	Pennsylvania
United States	Oregon HSU; Bld-Brain Barr/Neuro-Onc	Portland	Oregon
United States	University of Rochester Medical Center	Rochester	New York
United States	Washington University; Wash Uni. Sch. Of Med	Saint Louis	Missouri
United States	Florida Cancer Specialists & Research Institute	Saint Petersburg	Florida
United States	University of Utah; Huntsman Cancer Hospital	Salt Lake City	Utah
United States	Texas Oncology San Antonio Medical Center	San Antonio	Texas
United States	Seattle Cancer Care Alliance; Investigational Drug Service	Seattle	Washington
United States	Northwest Cancer Specialists - Portland (SW Barnes Rd)	Tigard	Oregon
United States	Georgetown University Medical Center	Washington	District of Columbia
United States	Florida Cancer Specialists	West Palm Beach	Florida
United States	Shenandoah Oncology Associates	Winchester	Virginia
United States	North Star Lodge	Yakima	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Brazil,  Canada,  China,  Czechia,  France,  Germany,  Hong Kong,  Italy,  Japan,  Korea, Republic of,  New Zealand,  Poland,  Russian Federation,  Spain,  Switzerland,  Taiwan,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival (PFS) as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma		From randomization to the first occurrence of disease progression or relapse, or death from any cause, whichever occurs earlier (up to 38 months)
Secondary	Percentage of Participants With Complete Response (CR) as Assessed by Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) by Blinded Independent Central Review (BICR)		End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 8 [Cycle length=21 days] [up to Week 32])
Secondary	Event-Free Survival-Efficacy (EFSeff) as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma		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)
Secondary	Percentage of Participants Who are Progression Free as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma		24 months after enrollment (up to approximately 65 months)
Secondary	Overall Survival		From randomization until death from any cause (up to approximately 65 months)
Secondary	Percentage of Participants With CR as Assessed by FDG-PET by Investigator		End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 8 [Cycle length=21 days] [up to Week 32])
Secondary	Disease-Free Survival (DFS) as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma		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)
Secondary	Duration of Response as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma		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)
Secondary	Event-Free Survival-All Causes (EFSall) as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma		From randomization to disease progression or relapse, or death from any cause, or initiation of any NALT (up to approximately 65 months)
Secondary	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		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)
Secondary	Time to Deterioration in Functional Assessment of Cancer Therapy-Lymphoma Lymphoma Subscale (FACT-Lym LymS)		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)
Secondary	Percentage of Participants Achieving Meaningful Improvement in EORTC QLQ-C30 Physical Functioning and Fatigue		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)
Secondary	Percentage of Participants Achieving Meaningful Improvement in FACT-Lym LymS		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)
Secondary	EORTC QLQ-C30 Treatment-Related Symptoms Score		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)
Secondary	Functional Assessment of Cancer Treatment/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) Peripheral Neuropathy Score		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)
Secondary	Percentage of Participants With adverse Events (AEs)		From randomization to the end of study (up to approximately 65 months)
Secondary	Serum Concentration of Total Polatuzumab Vedotin		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)
Secondary	Plasma Concentration of Polatuzumab Vedotin Conjugate (Antibody-Conjugated Mono-Methyl Auristatin E [acMMAE])		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)
Secondary	Plasma Concentration of Polatuzumab Vedotin Unconjugated MMAE		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)
Secondary	Percentage of Participants With Anti-Drug Antibody (ADA) to Polatuzumab Vedotin		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)