A Study Of PF-05280586 (Rituximab-Pfizer) Or MabThera® (Rituximab-EU) For The First-Line Treatment Of Patients With CD20-Positive, Low Tumor Burden, Follicular Lymphoma (REFLECTIONS B328-06)

Follicular Lymphoma Clinical Trial

Official title:

A PHASE 3, RANDOMIZED, DOUBLE-BLIND STUDY OF PF-05280586 VERSUS RITUXIMAB FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH CD20-POSITIVE, LOW TUMOR BURDEN, FOLLICULAR LYMPHOMA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02213263
• Other study ID #: B3281006
• Secondary ID: 2014-000132-41RE
• Status: Completed
• Phase: Phase 3
• Start date: September 30, 2014
• Est. completion date: April 19, 2018

Study information

• Verified date: June 2019
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will compare the safety and effectiveness of PF-05280586 versus rituximab-EU in patients with CD20-positive, low tumor burden follicular lymphoma. The primary hypothesis to be tested in this study is that the effectiveness of PF-05280586, as measured by the Overall Response Rate, is similar to that of rituximab-EU.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 394
• Est. completion date: April 19, 2018
• Est. primary completion date: October 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Confirmed diagnosis of low tumor burden, CD20-positive follicular lymphoma

• Ann Arbor Stage II, III, or IV

Exclusion Criteria:

• Not a candidate for treatment with rituximab as a single-agent

• Evidence of transformation to a high grade or diffuse large B-cell lymphoma

• Any previous systemic therapy for B-cell NHL, including chemotherapy, immunotherapy, or steroids

• Any prior treatment with rituximab

• Active, uncontrolled infection

Related Conditions & MeSH terms

• Follicular Lymphoma
• Lymphoma
• Lymphoma, Follicular

Intervention

Biological:
• PF-05280586
PF-05280586 (rituximab-Pfizer) concentrate for solution for infusion 375mg/m2 administered via IV infusion on Days 1, 8, 15, and 22
• MabThera®
MabThera® (rituximab-EU) concentrate for solution for infusion 375mg/m2 administered via IV infusion on Days 1, 8, 15, and 22

Locations

Country	Name	City	State
Austria	Kepler Universitaetsklinikum GmbH	Linz
Austria	Kepler Universitaetsklinikum GmbH	Linz
Austria	Krankenhaus der Barmherzigen Schwestern Linz	Linz
Belarus	Healthcare Institution "Brest Regional Oncologic Dispensary"	Brest
Belarus	SI 'Republican Research and Practice Centre of Oncology and Medical Radiology n.a. N.N. Alexandrov'	Lesnoy	Minsk Region
Belarus	SI 'Republican Research and Practice Centre of Oncology and Medical Radiology n.a. N.N. Alexandrov'	Lesnoy	Minsk Region
Belarus	Healthcare Institution 'Minsk City Clinical Oncology Dispensary'	Minsk
Belarus	SI Republican Research and Practice Centre of oncology and medical radiology n.a N.N Alexandrov	Republic Of Belarus
Belgium	Hopital Erasme	Brussels
Belgium	Nuclear Medicine Department	Brussels
Belgium	Grand Hopital de Charleroi-Site Notre-Dame	Charleroi
Belgium	PET/CT facility: Grand Hopital de Charleroi (GHdC) - site Notre-Dame	Charleroi
Belgium	Pharmacy Department: Grand Hopital de Charleroi (GHdC) - site Notre-Dame	Charleroi
Belgium	Pharmacy Department, Centre Hospitalier De Jolimont - Lobbes	La Louviere (Haine-Saint Paul)
Belgium	Centre Hospitalier de Jolimont - Lobbes	La Louviere (Haine-Saint-Paul)
Belgium	Radiology Department	La Louviere (Haine-Saint-Paul)
Belgium	C.H.U. Ambroise Pare	Mons
Belgium	Pharmacy Department, CHU Ambroise Pare	Mons
Brazil	Centro de Imagens da Faculdade de Medicina - INCT Medicina Nuclear - PET/CT	Belo Horizonte	MG
Brazil	Hospital das Clinicas Universidade Federal de Minas Gerais	Belo Horizonte	Minas Gerais
Brazil	Unidade Funcional Apoio Diagnostico e terapeutica por Imagem do HC/UFMG - CT Scan	Belo Horizonte	MG
Brazil	CAEP - Centro Avancado de Estudos e Pesquisas LTDA	Campinas	SP
Brazil	CEMEDI	Campinas	SP
Brazil	CENNI Oncologia	Campinas	SP
Brazil	Hospital e Maternidade Madre Theodora LTDA	Campinas	SP
Brazil	Instituto Radium	Campinas	SP
Brazil	Clinica Multimagem	Goiania	GO
Brazil	Hospital das Clinicas da Universidade Federal de Goias \ Centro de Pesquisa Clinica	Goiania	GO
Brazil	Fundacao Amaral Carvalho / Fundacao Dr. Amaral Carvalho	Jau	SAO Paulo
Brazil	Fundacao Amaral Carvalho / Fundacao Dr. Amaral Carvalho	Jau	SAO Paulo
Brazil	Unidade de Quimioterapia	Jaú	SAO Paulo
Brazil	CDI - Centro de Diagnostico por Imagem do Hospital Sao Lucas da PUCRS	Porto Alegre	RS
Brazil	Central de Misturas Intravenosas do Hospital de Clinicas de Porto Alegre	Porto Alegre	RIO Grande DO SUL
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	RIO Grande DO SUL
Brazil	Hospital de Clinicas de Porto Alegre - Centro de Pesquisa Clinica	Porto Alegre	RIO Grande DO SUL
Brazil	InsCer - Instituto do Cerebro do Rio Grande do Sul - PUCRS	Porto Alegre	RS
Brazil	Servico de Radiologia do Hospital de Clinicas de Porto Alegre	Porto Alegre	RIO Grande DO SUL
Brazil	Uniao Brasileira de Educacao e Assistencia (UBEA) - Hospital Sao Lucas da PUCRS -	Porto Alegre	RS
Brazil	Hospital Santa Izabel - Setor de Bioimagem	Salvador	Bahia
Brazil	Hospital Santa Izabel / Santa Casa de Misericordia da Bahia	Salvador	Bahia
Brazil	Casa da Esperanca	Santo Andre	SAO Paulo
Brazil	Fundacao do ABC - FMABC/ Faculdade de Medicina ABC ( CEPHO - Centro de Estudos e Pesquisas de	Santo Andre	SP
Brazil	Tecnolab	Sao Bernardo do Campo	SAO Paulo
Brazil	Casa de Saude Santa Marcelina (Centro de Pesquisa Santa Marcelina)	Sao Paulo	SP
Brazil	Fleury	Sao Paulo
Brazil	Hospital Bandeirantes	Sao Paulo	SP
Brazil	Hospital das Clinicas da Faculdade de Medicina da USP / Fundacao Faculdade de Medicina MEC MPAS	Sao Paulo	SP
Brazil	IEP Sao Lucas - Instituto de Ensino e Pesquisa Sao Lucas / HEMOMED - Instituto de Oncologia e	Sao Paulo
Brazil	IEP São Lucas (Pharmacy)	São Paulo	SP
Croatia	University Hospital Center Zagreb, Department of Nuclear Medicine and Radiation Protection	Zagreb
Croatia	University Hospital Center Zagreb, Department of Pathology and Cytology	Zagreb
Croatia	University Hospital Center Zagreb, Department of Radiology	Zagreb
Croatia	University Hospital Centre "Sestre Milosrdnice"	Zagreb
Croatia	University Hospital Centre Zagreb	Zagreb
France	Hopital Duchenne Chu - Boulogne Sur Mer	Boulogne Sur Mer	NAP
France	Hopital Duchenne Chu - Boulogne Sur Mer	Boulogne Sur Mer
France	Centre Hospitalier De Bourg En Bresse	Bourg En Bresse Cedex
France	Hopital Morvan-CHU Brest- Service Hematologie Clinique	Brest
France	Centre Hospitalier Universitaire Cote de Nacre	Caen
France	Centre Hospitalier du Mans	Le Mans
France	Clinique de la Sauvegarde	Lyon
France	CHU Marseille Hopital de La Conception	Marseille	Marseille Cedex 05
France	CH de Mulhouse, Hopital Emile Muller	Mulhouse	Mulhouse Cedex
Georgia	"LTD ""M. Zodelava's Hematology Centre"""	Tbilisi
Georgia	High Technology Medical Center, University Clinic	Tbilisi
Georgia	LTD "Research Institute of Clinical Medicine"	Tbilisi
Germany	Charite - Universitaetsmedizin Berlin	Berlin
Germany	Charite - Universitaetsmedizin Berlin, Campus Virchow-Klinikum	Berlin
Germany	Charite - Universitatsmedizin Berlin	Berlin
Germany	Charite - Universitatsmedizin Berlin - Campus Benjamin Franklin	Berlin
Germany	Charite - Universitatsmedizin Berlin, Campus Virchow-Klinikum	Berlin
Germany	Klinikum Chemnitz gGmbH	Chemnitz
Germany	Klinikum Chemnitz gGmbH - Institut fuer Interventionelle Radiologie und Neuroradiologie	Chemnitz
Germany	Klinikum Chemnitz gGmbH - Klinik fuer Nuklearmedizin	Chemnitz
Germany	Klinikum Chemnitz gGmbH - Zentralapotheke	Chemnitz
Germany	Universitaetsklinikum Essen (AoeR)	Essen
Germany	Universitatsklinikum Essen (AoR)	Essen
Germany	Apotheke des St. Anna Hospital	Herne
Germany	DokuSan Gesellschaft fuer Medizinische Studien mbH & Co. KG	Herne
Germany	EVK Eickel	Herne
Germany	Praxis im Koeln Triangle	Koeln
Germany	Gemeinschaftspraxis fuer Diagnostische Radiologie und Nuklearmedizin	Mutlangen
Germany	Kliniken Ostalb, Stauferklinikum Schwaebisch Gmuend, Zentrum fuer Innere Medizin	Mutlangen
Germany	Stauferklinikum Schwaebisch Gmuend, Apotheke	Mutlangen
Germany	Universitaetsmedizin Rostock	Rostock
Germany	Klinikum Stuttgart, Klinik fuer Nuklearmedizin	Stuttgart
Germany	Vinzenz von Paul Kliniken gGmbH	Stuttgart
Germany	Radiologie Rhein-Sieg	Troisdorf
Germany	Ueberoertliche Berufsausuebungsgemeinschaft Drs. med. Helmut Forstbauer	Troisdorf
Germany	Zentralapotheke	Troisdorf
Greece	"""ATTIKON"" Gen. Univ. Hosp"	Athens
Greece	Bioiatriki	Athens
Greece	Bioiatriki S.A.	Athens
Greece	Gen. Hosp. of Athens "Evangelismos - Eye Hosp.- Polikliniki"	Athens
Greece	Gen. Hosp. of Athens "Evangelismos-Eye Hosp. - Polikliniki"	Athens
Greece	Gen. Hosp. of Athens "Evangelismos-Eye Hosp.-Polikliniki"	Athens
Greece	Gen.Hosp.of Athens "Evangelismos-Eye Hosp.-polikiliniki"	Athens
Greece	General Hospital of Athens "Evangelismos - Eye Hosp. - Polikliniki"	Athens
Greece	General Hospital of Athens 'Laiko'	Athens
Greece	"ATTIKON'' Gen. Univ. Hosp.	Chaidari, Athens
Greece	Magnitiki Patron	Patras
Greece	University General Hospital of Patras	Patras
India	HealthCare Global Enterprises Limited	Bangalore	Karnataka
India	Apollo Speciality Hospital	Chennai	Tamilnadu
India	Department of Radiology	Chennai	Tamilnadu
India	Global Hospitals	Hyderabad	Telangana
India	Vijaya Diagnostic Centre	Hyderabad	Telangana
India	R.K. Birla Cancer Center, Sawai Man Singh Hospital	Jaipur	Rajasthan
India	N.R.S Medical College and Hospital	Kolkata	WEST Bengal
India	Spandan PET-CT Unit	Kolkata	WEST Bengal
India	Mangalore Institute of Oncology	Mangalore	Karanataka
India	Kasturba Medical College and Hospital	Manipal	Karnataka
India	Curie Manavata Cancer Centre	Nashik	Maharashtra
India	Department of Radiology, Curie Manavata Cancer Centre	Nashik	Maharashtra
India	Rajiv Gandhi Cancer Institute & Research Center (RGCIRC)	New Delhi
India	Department of Radiology	Pune	Maharashtra
India	Jehangir Clinical Development Centre Pvt. Ltd.	Pune	Maharashtra
India	Ruby Hall clinic	Pune	Maharashtra
India	Pathology Department, Unique Hospital Multispeciality & Research Institute	Surat	Gujarat
India	Super Scan Imaging Centre	Surat	Gujarat
India	Zircon- BIC Imaging Centre	Surat	Gujarat
Italy	U.O. di Ematologia e CTMO - Istituti Ospedalieri di Cremona	Cremona	CR
Italy	IRCSS A.O.U. San Martino - IST - UO Clinica Ematologica	Genova
Italy	U.O. Ematologia 1 - IRCCS AOU San Martino-IST	Genova	GE
Italy	Unità semplice di Medicina Nucleare	Latina	NAP
Italy	IRST - IRCCS U. O. Oncologia Medica	Meldola	FC
Italy	Istituto Europeo di Oncologia	Milano	MI
Italy	SC Ematologia, Fondazione IRCCS Ist Nazionale dei Tumori	Milano
Italy	Unita di Ricerca Clinica	Monza	MB
Italy	Padiglione 1, Torre delle medicine, 6 piano	Parma
Italy	Ematologia e Centro Trapianti - AZ Osp. Ospedali Riuniti Marche Nord (AORMN) - Presidio S. Salvatore	Pesaro
Italy	U.O. Ematologia Universitaria - Dip. Di Oncologia dei Trapianti - AOU Pisana	Pisa
Italy	Medicina nucleare	Reggio Emilia	Reggio
Italy	Radiologia	Reggio Emilia	Reggio
Italy	SC Ematologia - SC Ematologia - Arcispedale Santa Maria Nuova - IRCCS	Reggio Emilia	Reggio
Italy	Policlinico Universitario Campus Bio- Medico-U.O.C. di Ematologia Trapianto Cellule Staminali	Roma
Italy	"Dipartimento di Biotecnologie Cellulari ed Ematologia, Universita ""Sapienza""	Rome	Rome Rm
Italy	Az Ospedaliera Santa Maria	Terni	PG
Italy	Clinica Ematologica - A.O.U. Ospedali Riuniti di Ancona	Torrette Ancona	Palermo
Japan	Akita University Hospital	Akita City	Akita
Japan	Chiba Cancer Center	Chiba-shi	Chiba
Japan	Fukuoka Wajiro PET Diagnostic Imaging Clinic	Fukuoka
Japan	National Hospital Organization Kyushu Cancer Center	Fukuoka-Shi	Fukuoka
Japan	National Hospital Organization Kyushu Medical Center	Fukuoka-shi	Fukuoka
Japan	Kanazawa Advanced Medical Center	Kanazawa	Ishikawa
Japan	National Hospital Organization Kanazawa Medical Center	Kanazawa	Ishikawa
Japan	National Hospital Organization Osaka Minami Medical Center	Kawachinagano	Osaka
Japan	Kobe City Medical Center General Hospital	Kobe-City	Hyogo
Japan	National Hospital Organization Kumamoto Medical Center	Kumamoto-shi	Kumamoto-ken
Japan	Uozumi Clinic	Kumamoto-shi	Kumamoto-ken
Japan	Aizawa Hospital	Matsumoto-shi	Nagano
Japan	National Hospital Organization Tokyo Medical Center	Meguro-Ku	Tokyo
Japan	National Hospital Organization Matsumoto Medical Center	Nagano
Japan	Nagano Red Cross Hospital	Nagano-shi	Nagano
Japan	East Nagoya Imaging Diagnosis Center	Nagoya	Aichi
Japan	Nagoya Daini Red Cross Hospital	Nagoya	Aichi
Japan	Hanwa Dai 2 Senboku Hospital	Naka-ku Sakai	Osaka
Japan	Kochi Medical School Hospital	Okocho, Nankoku	Kochi
Japan	National Hospital Organization Nagasaki Medical Center	Omura	Nagasaki
Japan	Osaka City University Hospital	Osaka-City	Osaka
Japan	National Hospital Organization Sendai Medical Center	Sendai-shi	Miyagi
Japan	Sendai Kousei Hospital	Sendai-shi	Miyagi
Japan	Showa University Hospital	Shinagawa-ku	Tokyo
Japan	National Hospital Organization Disaster Medical Center	Tachikawa	Tokyo
Japan	Tokushima University Hospital	Tokushima-Shi	Tokushima
Japan	Musashimurayama Hospital	Tokyo
Japan	Yamagata University Hospital	Yamagata-Shi	Yamagata
Japan	Showa University Northern Yokohama Hospital	Yokohama-shi	Kanagawa-ken
Korea, Republic of	Hallym University Sacred Heart Hospital	Anyang-si	Gyeonggi-do
Korea, Republic of	Inje University Busan Paik Hospital	Busan
Korea, Republic of	Chonbuk National University Hospital	Jeonju-si	Jeollabuk-do
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Ulsan University Hospital	Ulsan	Korea
Lebanon	Doctors Center Radiology	Beirut
Lebanon	Mount Lebanon Hospital	Beirut
Lebanon	Middle East Institute Of Health	El Metn
Lebanon	Ain Wazein Hospital	Mount Lebanon
Lebanon	Hammoud Hospital, University Medical Center	Saida	Southern Governate
Mexico	Vely Grupo Medico Quirurgico, S.A. de C.V.	Cuautitlan Izacalli	Estado DE Mexico
Mexico	Phylasis Clinicas Research S. de R.L. de C.V.	Cuautitlan Izcalli	Estado DE Mexico
Mexico	Grupo Medico Camino S.C.	Mexico City	Distrito Federal
Mexico	Imagenus	Mexico City	Distrito Federal
Mexico	Isos Pharmacorp, S.A. de C.V.	Mexico City	Distrito Federal
Mexico	Centro Universitario de Imagen Diagnostica, Radiologia e Imagen del Hospital Universitario	Monterrey	Nuevo LEON
Mexico	Hospital Universitario "Dr. Jose Eleuterio Gonzalez"	Monterrey	Nuevo LEON
Mexico	Cirurgia y Ginecobstetricia de Oaxaca, S.A de C.V.	Oaxaca
Mexico	Oaxaca Site Management Organization S.C.	Oaxaca
Mexico	Hospital Angeles Puebla	Puebla
Mexico	Cancerologia de Queretaro S.C.	Queretaro
Mexico	Hospital Infantil Teleton de Oncologia	Queretaro
Mexico	Hospital San Jose Norte	Queretaro
Peru	Pet Scan Peru	Lima
Peru	Resocentro	Lima
Peru	Instituto Nacional de Enfermedades Neoplasicas	Surquillo	Lima
Philippines	University of Philippines Manila-Philippine General Hospital	Manila	Metro Manila
Philippines	St. Luke's Medical Center	Quezon City
Poland	Klinika Nowotworow Ukladu Chlonnego Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie	Warszawa
Poland	Apteka Dolnoslaskiego Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku	Wroclaw
Poland	Dolnoslaskie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku	Wroclaw
Poland	Euromedic Wroclawskie Centrum Medyczne I	Wroclaw
Poland	Euromedic Wroclawskie Centrum Medyczne II	Wroclaw
Poland	Euromedic Wroclawskie Centrum Medyczne III	Wroclaw
Portugal	Hospital de Braga	Braga
Portugal	Hospital CUF Descobertas	Lisboa
Portugal	Unidade Local de Saude de Matosinhos E.P.E. - Hospital Pedro Hispano S.A.	Matosinhos	Porto
Portugal	Centro Hospitalar do Porto-Hospital de Santo Antonio E.P.E.	Porto
Portugal	CIMC	Porto
Portugal	Dr. Campos Costa Clinic	Porto
Portugal	Instituto Portugues de Oncologia do Porto Francisco Gentil E.P.E	Porto
Portugal	Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.	Vila Nova de Gaia
Puerto Rico	Modern Radiology, PSC	Coto Laurel
Puerto Rico	Ad-Vance Medical Research, LLC	Ponce
Puerto Rico	Caribe MRI and CT	Ponce
Romania	Policlinica de Diagnostic Rapid SA	Brasov
Romania	Policlinica de Diagnostic Rapid, Hematologie	Brasov
Romania	Affidea Fundeni	Bucuresti
Romania	Affidea Romania SRL	Bucuresti
Romania	Hiperdia Ritmului	Bucuresti
Romania	Spitalul Clinic Colentina	Bucuresti
Romania	Spitalul Clinic Coltea, Clinica de Hematologie	Bucuresti
Romania	Clinica de Hematologie-Institutul Oncologic, Prof. Dr. Ion Chiricuta	Cluj-Napoca
Romania	CT Clinic S.R.L.	Cluj-Napoca
Romania	Institutul Oncologic Prof. Dr. Ion Chiricuta, Laborator Radiologie si Imagistica Medicala	Cluj-Napoca
Romania	Institutul Oncologic Prof. Dr. Ion Chiricuta, Sectia Oncologie Medicala	Cluj-Napoca
Russian Federation	"State Budget Healthcare Institution ""Chelyabinsk Regional Clinical Center of Oncology	Chelyabinsk
Russian Federation	Federal State-Financed Institution 'North-Caucasian Research and Clinical Center'	Lermontov	Stavropol Region
Russian Federation	FSBSI 'N.N.Blokhin Russian Cancer Research Center' of MoH of RF	Moscow
Russian Federation	LLC "VitaMed"	Moscow
Russian Federation	Ramsay Diagnostics	Moscow
Russian Federation	Russian Cancer Research Centre them N.N. Blokhin	Moscow
Russian Federation	SBHI of Moscow City Clinical Hospital n.a. S.P.Botkin of Healthcare Department of Moscow	Moscow
Russian Federation	"SBHI of NNR ""Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko"""	Nizhniy Novgorod	Nizhniy Novgorod Region
Russian Federation	LLC MC "MRT-Diagnostika"	Nizhniy Novgorod	Nizhniy Novgorod Region
Russian Federation	A.Tsyb Medical Radiological Research Centre -	Obninsk	Kaluga Region
Russian Federation	FSBI "Russian Research Centre of Radiology and Surgical Technologies" of MoH of RF	Pesochniy Town	Saint-petersburg
Russian Federation	Private medical institution "Euromedservice"	Pushkin	Saint Petersburg
Russian Federation	SBHI of Stavropol Region "Pyatigorsk Interdistrict Oncology Dispensary	Pyatigorsk	Stavropol Region
Russian Federation	State Budgetary Institution of Healthcare "Leningrad Regional Clinical Hospital"	Saint Petersburg
Russian Federation	Dr. Berezin Medical Institute	Saint-Petersburg
Russian Federation	FSBI "Russian Research Centre of Radiology and Surgical Technologies	Saint-Petersburg	Pesochniy
Russian Federation	FSBI "Russian Research Centre of Radiology and Surgical Technologies	Saint-Petersburg	Pesochniy TOWN
Russian Federation	FSBI "Russian Research Centre of Radiology and Surgical Technologies n.a. A.M. Granov" of MoH of RF	Saint-Petersburg	Pesochniy
Russian Federation	FSBI "Russian Research Centre of Radiology and Surgical Technologies named after academician	Saint-Petersburg	Pesochniy
Russian Federation	FSBI "Russian Research Centre of Radiology and Surgical Technologies"	Saint-Petersburg	Pesochniy TOWN
Russian Federation	FSBI "Russian Research Centre of Radiology and Surgical Technologies" of MoH of RF	Saint-Petersburg	Pesochniy TOWN
Russian Federation	FSBI 'National Medical Oncology Research Centre n.a. N.N.Petrov'	Saint-Petersburg	Pos.pesochny
Russian Federation	FSBI 'Russian Research Centre of Radiology and Surgical Technologies	Saint-Petersburg	Pesochniy TOWN
Russian Federation	N.P. Bechtereva Institute of Human Brain of the Russian Academy of Sciences	Saint-Petersburg
Russian Federation	N.P. Bechtereva Institute of the Human Brain of the Russian Academy of Sciences	Saint-Petersburg
Russian Federation	Non-state healthcare institution "Road Clinical Hospital of Joint Stock Company "Russian Railways"	Saint-Petersurg
Russian Federation	State Healthcare Institution Republican Oncology Dispensary	Saransk	Mordovian Republic
Russian Federation	Branch office of LLC 'PET-Technology' at Ufa city	Ufa	Republic Bashkortostan
Russian Federation	State Budgetary Healthcare Institution "Republican Clinical Oncology Dispensary of the Ministry	Ufa	Republic Bashkortostan
Russian Federation	GBUZ of Yaroslavl Region "Regional Clinical Hospital"	Yaroslavl
Russian Federation	Yaroslavl State Medical Academy	Yaroslavl
South Africa	NIKSCH & PARTNERS t/a CAPITAL RADIOLOGY	Groenkloof	Gauteng
South Africa	The Medical Oncology Centre of Rosebank	Johannesburg	Gauteng
South Africa	Albert Alberts Stem Cell Transplant Centre	Pretoria	Gauteng
South Africa	Department of Medical Oncology, University of Pretoria, Steve Biko Academic Hospitals Complex	Pretoria	Gauteng
South Africa	Dr JN De Jong and Partners t/a East Rad	Pretoria	Gauteng
South Africa	NIKSCH & PARTNERS t/a CAPITAL RADIOLOGY	Pretoria	Gauteng
South Africa	Drs Sulman & Partners Specialist Radiologists	Rosebank	Gauteng
South Africa	Drs Bloch & Partners Incorporated	Sandton	Gauteng
Spain	Complejo Hospitalario Universitario A Coruna	A Coruna
Spain	Hospital Modelo	A Coruna
Spain	Hospital Universitario Sanitas La Zarzuela	Aravaca	Madrid
Spain	CETIR, Centre Medic	Barcelona
Spain	Hospital Del Mar	Barcelona
Spain	Hospital Quiron de Barcelona, IEC	Barcelona
Spain	Radiodiagnostic CETIR - Clinica del Pilar	Barcelona
Spain	Hospital Universitario Puerta del Mar	Cadiz
Spain	Hospital Clinico Universitario Virgen de la Arrixaca	El Palmar	Murcia
Spain	Hospital Clínico Universitario Virgen de la Arrixaca	El Palmar	Murcia
Spain	Hospital Universitario Fundacion Jimenez Diaz	Madrid
Spain	Hospital Universitario Sanitas La Moraleja	Madrid
Spain	Centro CIMES	Malaga
Spain	Centro Mario Gallegos	Malaga
Spain	Hospital universitario Virgen de la Victoria	Malaga
Spain	Hospital Rey Juan Carlos	Mostoles	Madrid
Spain	Complejo Hospitalario de Ourense. Hematología	Ourense
Spain	Hospital Parc Tauli	Sabadell	Barcelona
Spain	Onkologikoa	San Sebastian	Guipuzcoa
Spain	Hospital Universitario Virgen del Rocio	Sevilla
Spain	Hospital do Meixoeiro Complejo Hospitalario Universitario de Vigo	Vigo	Pontevedra
Spain	H. Quiron Zaragoza	Zaragoza
Spain	Hospital de Dia Quiron Zaragoza	Zaragoza
Switzerland	Universitatsspital Basel	Basel
Switzerland	Inselspital Bern	Bern
Switzerland	Apotheke, Spital STS AG	Thun
Switzerland	Onkologiezentrum Thun-Berner Oberland Spital Sts Ag	Thun
Switzerland	Kantonsapotheke Zuerich	Zuerich
Switzerland	UniversitaetsSpital Zuerich	Zuerich
Thailand	Cardiology Unit,Department of Medicine, Faculty of Medicine, Ramathibodi Hospital,	Bangkok
Thailand	Department of Radiology, Ramathibodi Hospital	Bangkok
Thailand	National Cancer Institute	Bangkok
Turkey	Dr. Abdurrahman Yurtaslan Ankara Onkoloji Eg. ve Aras.	Ankara
Turkey	Hacettepe Universitesi Tip Fakultesi Onkoloji Hastanesi	Ankara
Turkey	Integra Gurses Teshis Tedavi ve Saglik Hizmetleri A.S.	Ankara
Turkey	Ultramar Tibbi Gorunteleme Merkezi	Ankara
Turkey	Ultramar Tibbi Goruntuleme Merkezi	Ankara
Turkey	Adnan Menderes University Medical Faculty	Aydin
Turkey	Gaziantep Universitesi Sahinbey Arastirma ve Uygulama	Gaziantep
Turkey	Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi	Gaziantep
Turkey	Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi	Istanbul
Turkey	Ege Universitesi Tip Fakultesi Ic Hastaliklari Anabilim Dali	Izmir
Turkey	EGE-RAD Bilgisayarli Tomografi Ozel Saglik Hizmetleri ve Malzemeleri Tic.Ltd.Sti.	Izmir
Turkey	Erciyes Universitesi Tip Fakultesi	Kayseri
Turkey	Erciyes Universitesi Tip Fakultesi Nukleer Tip Laboratuvari	Kayseri
Turkey	Erciyes Universitesi Tip Fakultesi Radyoloji Laboratuvari	Kayseri
Turkey	Inonu Universitesi Tip Fakultesi Turgut Ozal Tip Merkezi	Malatya
Turkey	Celal Bayar University Medical Faculty	Manisa
Turkey	Ondokuz Mayis Universitesi Tip Fakultesi	Samsun
Ukraine	"Municipal Institution ""Chernivtsi Regional Clinical Oncology Center"",	Chernivtsi
Ukraine	MI 'City Dnipropetrovsk Multi-field Clin. Hospital #4 of DRC',	Dnipropetrovsk
Ukraine	Municipal Non-Profit Enterprise "Regional Oncology Centre"	Kharkiv
Ukraine	National Cancer Institute	Kyiv
Ukraine	"MedX-Ray International Group" LLC	Obukhiv	KYIV Region
Ukraine	"Mediks-rey International Group" LLC	Obukhiv District	KYIV Region
Ukraine	"MedX-rey International Group" LLC	Obukhiv District	KYIV Region
Ukraine	"Central City Clinical Hospital, City Oncology Center, SHEI ""Uzhhorod National University"", Chair	Uzhhorod
Ukraine	Podilskyy Regional Oncology Center, Chemotherapy Department	Vinnytsia
Ukraine	LLC "Diaservis"	Zaporizhzhia
Ukraine	Municipal Establishment 'Zaporizhzhia Regional Clinical Oncology Dispensary'	Zaporizhzhia
United Kingdom	Royal United Hospitals Bath NHS Foundation Trust	Bath
United Kingdom	Cobalt Diagnostic Imaging	Cheltenham	Glos.
United Kingdom	Barts Health NHS Trust	London
United Kingdom	Positron Emission Tomography (PET) Centre	Newcastle upon Tyne
United Kingdom	City Hospitals Sunderland NHS Foundation Trust-Sunderland Royal Hospital	Sunderland
United Kingdom	Diagnostic Imaging	Sunderland
United Kingdom	Southend University Hospital NHS Foundation Trust	Westcliff-On-Sea	Essex
United States	Pacific Cancer Medical Center, Inc.	Anaheim	California
United States	The Oncology Institute of Hope and Innovation	Anaheim	California
United States	Rocky Mountain Cancer Centers	Aurora	Colorado
United States	PET/CT facility Seton Imaging Center	Baltimore	Maryland
United States	Saint Agnes Hospital	Baltimore	Maryland
United States	Rcca Md Llc	Bethesda	Maryland
United States	Rocky Mountain Cancer Centers	Boulder	Colorado
United States	Cancer Center of Kansas	Chanute	Kansas
United States	Compassionate Care Research Group, Inc., at Compassionate Cancer Care Medical Group, Inc.	Corona	California
United States	Northwestern Medicine West Region	DeKalb	Illinois
United States	Rocky Mountain Cancer Centers	Denver	Colorado
United States	Cancer Center of Kansas	Dodge City	Kansas
United States	The Oncology Institute of Hope and Innovation	Downey	California
United States	Cancer Center of Kansas	El Dorado	Kansas
United States	Willamette Valley Cancer Institute and Research Center	Eugene	Oregon
United States	San Antonio Military Medical Center	Fort Sam Houston	Texas
United States	San Antonio Military Medical Center- Department of Pharmacy	Fort Sam Houston	Texas
United States	San Antonio Military Medical Center- Department of Radiology	Fort Sam Houston	Texas
United States	Investigational Products Center (I PC)	Fort Worth	Texas
United States	Investigational Products Center (IPC)	Fort Worth	Texas
United States	Compassionate Care Research Group, Inc., at Compassionate Cancer Care Medical Group, Inc.	Fountain Valley	California
United States	Cancer Center,Northwestern Medicine, West Region	Geneva	Illinois
United States	Global Cancer Research Institute (GCRI), Inc	Gilroy	California
United States	Saint Louise Regional Hospital Radiology Department (Radiology Only)	Gilroy	California
United States	South Valley Imaging Center (Imaging Only)	Gilroy	California
United States	Los Angeles Hematology Oncology Medical Group	Glendale	California
United States	Los Angeles Hematology Oncology Medical Group	Glendale	California
United States	The Oncology Institute of Hope and Innovation	Glendale	California
United States	Saint Francis Medical Center	Grand Island	Nebraska
United States	Saint Francis Medical Center, Saint Francis Cancer Treatment Center	Grand Island	Nebraska
United States	Brody School of Medicine at East Carolina University	Greenville	North Carolina
United States	Vidant Medical Center	Greenville	North Carolina
United States	Vidant Medical Center Pharmacy	Greenville	North Carolina
United States	Saint Francis Medical Center, Saint Francis Cancer Treatment Center	Hastings	Nebraska
United States	Comprehensive Cancer Centers of Nevada	Henderson	Nevada
United States	Comprehensive Cancer Centers of Nevada	Henderson	Nevada
United States	Millennium Oncology	Houston	Texas
United States	Cancer Center of Kansas	Independence	Kansas
United States	US Oncology Investigational Products Center (IPC)	Irving	Texas
United States	The University of Kansas Cancer Center	Kansas City	Missouri
United States	The University of Kansas Cancer Center	Kansas City	Missouri
United States	Cancer Center of Kansas	Kingman	Kansas
United States	Millennium Oncology	Kingwood	Texas
United States	University of Tennessee Medical Center	Knoxville	Tennessee
United States	Rocky Mountain Cancer Center-Lakewood (Laboratory)	Lakewood	Colorado
United States	Rocky Mountain Cancer Centers (RMCC) - Lakewood - St Anthony	Lakewood	Colorado
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	The University of Kansas Cancer Center	Lee's Summit	Missouri
United States	Cancer Center of Kansas	Liberal	Kansas
United States	Rocky Mountain Cancer Centers	Lone Tree	Colorado
United States	The Oncology Institute of Hope and Innovation	Long Beach	California
United States	Texas Oncology - Longview Cancer Center	Longview	Texas
United States	Los Angeles Hematology Oncology Medical Group	Los Angeles	California
United States	Los Angeles Hematology Oncology Medical Group	Los Angeles	California
United States	The Oncology Institute of Hope and Innovation	Lynwood	California
United States	Toledo Clinic Cancer Center - Maumee	Maumee	Ohio
United States	Cancer Center of Kansas	McPherson	Kansas
United States	The Oncology Institute of Hope and Innovation	Montebello	California
United States	Cancer Center of Kansas	Newton	Kansas
United States	The University of Kansas Cancer Center	Overland Park	Kansas
United States	Comprehensive Cancer Center at Desert Regional Medical Center	Palm Springs	California
United States	Cancer Center of Kansas	Parsons	Kansas
United States	Rocky Mountain Cancer Center Pueblo	Pueblo	Colorado
United States	Torrance Health Association DBA, Torrance Memorial Physician, Network/Cancer Care Associates	Redondo Beach	California
United States	Compassionate Care Research Group, Inc., at Compassionate Cancer Care Medical Group, Inc.	Riverside	California
United States	Cancer Center of Kansas	Salina	Kansas
United States	Global Cancer Research Institute, Inc.	San Jose	California
United States	O'Connor Hospital	San Jose	California
United States	PET Imaging of San Jose (Imaging Only)	San Jose	California
United States	The Oncology Institute of Hope and Innovation	Santa Ana	California
United States	Millennium Oncology	Shenandoah	Texas
United States	Holy Cross Hospital	Silver Spring	Maryland
United States	Holy Cross Hospital Hospital Pharmacy	Silver Spring	Maryland
United States	Holy Cross Hospital Resource Center	Silver Spring	Maryland
United States	Millennium Oncology	The Woodlands	Texas
United States	John D. Archbold Memorial Hospital	Thomasville	Georgia
United States	Lewis Hall Singletary Oncology Center At John D. Archbold Memorial Hospital	Thomasville	Georgia
United States	Toledo Clinic Cancer Center - Toledo	Toledo	Ohio
United States	Toledo Clinic, Inc.	Toledo	Ohio
United States	Torrance Memorial Medical Center	Torrance	California
United States	Texas Oncology-Tyler	Tyler	Texas
United States	Cancer Center of Kansas	Wellington	Kansas
United States	Maryland Oncology Hematology, P.A.	Wheaton	Maryland
United States	Innovative Clinical Research Institute (ICRI)	Whittier	California
United States	The Oncology Institute of Hope and Innovation	Whittier	California
United States	Cancer Center of Kansas	Wichita	Kansas
United States	Cancer Center of Kansas	Wichita	Kansas
United States	Cancer Center Of Kansas	Winfield	Kansas
United States	Yakima Valley Memorial Hospital/North Star Lodge Cancer Center	Yakima	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Austria,  Belarus,  Belgium,  Brazil,  Croatia,  France,  Georgia,  Germany,  Greece,  India,  Italy,  Japan,  Korea, Republic of,  Lebanon,  Mexico,  Peru,  Philippines,  Poland,  Portugal,  Puerto Rico,  Romania,  Russian Federation,  South Africa,  Spain,  Switzerland,  Thailand,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (ORR): Percentage of Participants With Overall Response (OR) at Week 26	ORR was defined as the percentage of participants who achieved complete response (CR) or partial response (PR) in accordance with the revised response criteria for malignant lymphoma (Cheson 2007). CR was defined as disappearance of all evidence of disease. PR was defined as regression of measureable disease and no new sites.	Week 26
Secondary	Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE was any untoward medical occurrence in participants who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events after first dose of study drug that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious.	Baseline up to Week 52
Secondary	Number of Participants With Treatment Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events after first dose of study drug that were absent before treatment or that worsened relative to pretreatment state. Relatedness to treatment was assessed by investigator. AEs included both serious and non-serious AEs.	Baseline up to Week 52
Secondary	Number of Participants With Grade 3 or Higher Treatment-Emergent Adverse Events (AEs) as Graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03	An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 1=Mild, asymptomatic or mild symptoms, Grade 2=Moderate; minimal, local or noninvasive intervention indicated, Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life threatening) events caused participant to be in imminent danger of death. Grade 5 = death. Treatment-emergent were events after first dose of study drug that were absent before treatment or that worsened relative to pretreatment state.	Baseline up to Week 52
Secondary	Number of Participants With Grade 3 or Higher Treatment-Related Treatment-Emergent Adverse Events (AEs) as Graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03	Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Grade 1=Mild, asymptomatic or mild symptoms, Grade 2=Moderate; minimal, local or noninvasive intervention indicated; Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. Grade 5 = death. Treatment-emergent were events after first dose of study drug that were absent before treatment or that worsened relative to pretreatment state.	Baseline up to Week 52
Secondary	Number of Participants With Clinically Significant Laboratory Abnormalities	Criteria for clinically significant laboratory abnormalities included total bilirubin (TB) less than (<) 2*upper limit of normal (ULN), alanine aminotransferase (ALT)<3*ULN; TB<2*ULN, ALT more than (>) 3 equal to (=) *ULN; TB<2*ULN, aspartate aminotransferase (AST)<3*ULN; TB<2*ULN, AST>=3*ULN. Data for only those categories are reported for which at least one participant had clinically significant laboratory abnormality.	Baseline up to Week 52
Secondary	Time to Treatment Failure (TTF)	TTF was defined as the time (in months) from date of randomization to first progression of disease based on central review, death due to any cause, or permanent discontinuation from treatment, or discontinuation from study for any reason, whichever came first. Progression was defined as any new lesion or increase by greater than or equal to (>=) 50% of previously involved sites from nadir. TTF was calculated using Kaplan-Meier method.	From randomization until disease progression, death or permanent discontinuation from treatment/study due to any reason, or up to Week 52
Secondary	Progression-Free Survival (PFS)	PFS was defined as the time (in months) from date of randomization to first progression of disease (PD) based on central review or death due to any cause in the absence of documented PD. PD was defined as any new lesion or increase by >=50% of previously involved sites from nadir. PFS was calculated using Kaplan-Meier method.	From randomization until disease progression or death due to any cause or up to Week 52
Secondary	Percentage of Participants With Complete Remission (CR) at Week 26	Complete Remission (CR) was defined as disappearance of all evidence of disease. CR was assessed by central review based on scans done at Week 26.	Week 26
Secondary	Duration of Response (DOR)	DOR was defined as the time (in months) from date of the first documentation of overall response (CR or PR) to the first documentation of progressive disease (PD) based on central review or to death due to any cause in the absence of documented PD. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measureable disease and no new sites. PD was defined as any new lesion or increase by >=50% of previously involved sites from nadir. DOR was calculated using Kaplan-Meier method.	From date of first documentation of overall response to first documentation of PD or to death due to any cause in absence of PD or up to Week 52
Secondary	Overall Survival	Overall survival was defined as the time (in months) from date of randomization to death due to any cause. For participants who were alive, overall survival was censored at the last contact. Overall survival was calculated using Kaplan-Meier method.	From randomization until death due to any cause or up to Week 52
Secondary	Maximum Observed Serum Concentration (Cmax) of PF-05280586 and Rituximab-EU		Predose (within 4 hours prior to start of infusion) on Days 1, 8, 15 and 22; within 15 minutes prior to end of infusion on Days 1 and 22
Secondary	Minimum Observed (Trough) Serum Concentration (Ctrough) of PF-05280586 and Rituximab-EU		Predose (within 4 hours prior to the start of dosing) on Day 1, 8, 15, and 22
Secondary	Cluster of Differentiation (CD) 19-Positive B-Cell Counts		Baseline, Week 2, 3, 4, 5, 13, 26, 39, 52
Secondary	Number of Participants With Positive Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs)	Human serum ADA samples were analyzed for the presence or absence of anti-rituximab antibodies or anti-PF-05280586 antibodies using the validated drug-specific assay with a tiered approach using screening, confirmation and titer/quantitation. Human NAb serum samples testing ADA positive were analyzed for the presence or absence of neutralizing anti-rituximab antibody and neutralizing anti-PF-05280586 antibody using the validated drug-specific assay with a tiered approach using screening, confirmation and titer/quantitation. Participants with their ADA titer >= 1.88 were considered to be ADA positive. Only participants with a positive ADA result were further tested for NAb.	Baseline up to Week 52
Secondary	Number of Participants Reporting Immune-Based Adverse Effects	Immune-based adverse effects included infusion related reaction (IRR), adverse events which fulfill Sampson's criteria, and adverse events which belong to the Standardized Medical Dictionary for Regulatory Activities (MedDRA) Queries (SMQs) anaphylaxis or hypersensitivity reactions. Potential allergic and anaphylactic reactions were identified programmatically based on the criteria of Sampson et al, (2006).	Baseline up to Week 52

External Links

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