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)

June 18, 2019 updated by: Pfizer

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

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.

Study Overview

Status

Completed

Conditions

Follicular Lymphoma

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

394

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Austria
- - Linz, Austria, 4010
    - Krankenhaus Der Barmherzigen Schwestern Linz
  - Linz, Austria, 4020
    - Kepler Universitaetsklinikum GmbH
  - Linz, Austria, 4021
    - Kepler Universitaetsklinikum GmbH
Belarus
- - Brest, Belarus, 224027
    - Healthcare Institution "Brest Regional Oncologic Dispensary"
  - Minsk, Belarus, 220013
    - Healthcare Institution 'Minsk City Clinical Oncology Dispensary'
  - Republic Of Belarus, Belarus, 223040
    - SI Republican Research and Practice Centre of oncology and medical radiology n.a N.N Alexandrov
- Minsk Region
  - Lesnoy, Minsk Region, Belarus, 220013
    - SI 'Republican Research and Practice Centre of Oncology and Medical Radiology n.a. N.N. Alexandrov'
  - Lesnoy, Minsk Region, Belarus, 223040
    - SI 'Republican Research and Practice Centre of Oncology and Medical Radiology n.a. N.N. Alexandrov'
Belgium
- - Brussels, Belgium, 1070
    - Hôpital Erasme
  - Brussels, Belgium, 1200
    - Nuclear Medicine Department
  - Charleroi, Belgium, 6000
    - Grand Hopital de Charleroi-Site Notre-Dame
  - Charleroi, Belgium, 6000
    - PET/CT facility: Grand Hopital de Charleroi (GHdC) - site Notre-Dame
  - Charleroi, Belgium, 6000
    - Pharmacy Department: Grand Hopital de Charleroi (GHdC) - site Notre-Dame
  - La Louviere (Haine-Saint Paul), Belgium, 7100
    - Pharmacy Department, Centre Hospitalier De Jolimont - Lobbes
  - La Louviere (Haine-Saint-Paul), Belgium, 7100
    - Centre Hospitalier de Jolimont - Lobbes
  - La Louviere (Haine-Saint-Paul), Belgium, 7100
    - Radiology Department
  - Mons, Belgium, 7000
    - C.H.U. Ambroise Paré
  - Mons, Belgium, 7000
    - Pharmacy Department, CHU Ambroise Pare
Brazil
- - Sao Paulo, Brazil, 01236-030
    - IEP Sao Lucas - Instituto de Ensino e Pesquisa Sao Lucas / HEMOMED - Instituto de Oncologia e
  - Sao Paulo, Brazil, 01333-910
    - Fleury
- Bahia
  - Salvador, Bahia, Brazil, 40050-410
    - Hospital Santa Izabel - Setor de Bioimagem
  - Salvador, Bahia, Brazil, 40050-410
    - Hospital Santa Izabel / Santa Casa de Misericordia da Bahia
- GO
  - Goiania, GO, Brazil, 74175-150
    - Clinica Multimagem
  - Goiania, GO, Brazil, 74605-020
    - Hospital das Clinicas da Universidade Federal de Goias \ Centro de Pesquisa Clinica
- MG
  - Belo Horizonte, MG, Brazil, 30130-100
    - Centro de Imagens da Faculdade de Medicina - INCT Medicina Nuclear - PET/CT
  - Belo Horizonte, MG, Brazil, 30130-100
    - Unidade Funcional Apoio Diagnostico e terapeutica por Imagem do HC/UFMG - CT Scan
- Minas Gerais
  - Belo Horizonte, Minas Gerais, Brazil, 30130-100
    - Hospital das Clinicas Universidade Federal de Minas Gerais
- RIO Grande DO SUL
  - Porto Alegre, RIO Grande DO SUL, Brazil, 90035-903
    - Hospital de Clínicas de Porto Alegre
  - Porto Alegre, RIO Grande DO SUL, Brazil, 90035-903
    - Central de Misturas Intravenosas do Hospital de Clinicas de Porto Alegre
  - Porto Alegre, RIO Grande DO SUL, Brazil, 90035-903
    - Hospital de Clinicas de Porto Alegre - Centro de Pesquisa Clinica
  - Porto Alegre, RIO Grande DO SUL, Brazil, 90035-903
    - Servico de Radiologia do Hospital de Clinicas de Porto Alegre
- RS
  - Porto Alegre, RS, Brazil, 90610-000
    - CDI - Centro de Diagnostico por Imagem do Hospital Sao Lucas da PUCRS
  - Porto Alegre, RS, Brazil, 90610-000
    - InsCer - Instituto do Cerebro do Rio Grande do Sul - PUCRS
  - Porto Alegre, RS, Brazil, 90610-000
    - Uniao Brasileira de Educacao e Assistencia (UBEA) - Hospital Sao Lucas da PUCRS -
- SAO Paulo
  - Jau, SAO Paulo, Brazil, 17210-080
    - Fundacao Amaral Carvalho / Fundacao Dr. Amaral Carvalho
  - Jau, SAO Paulo, Brazil, 17210-120
    - Fundacao Amaral Carvalho / Fundacao Dr. Amaral Carvalho
  - Jaú, SAO Paulo, Brazil, 17210-120
    - Unidade de Quimioterapia
  - Santo Andre, SAO Paulo, Brazil, 09030-340
    - Casa da Esperanca
  - Sao Bernardo do Campo, SAO Paulo, Brazil, 09750-670
    - TECNOLAB
- SP
  - Campinas, SP, Brazil, 13075-460
    - CEMEDI
  - Campinas, SP, Brazil, 13075-460
    - Instituto Radium
  - Campinas, SP, Brazil, 13087-567
    - CAEP - Centro Avancado de Estudos e Pesquisas LTDA
  - Campinas, SP, Brazil, 13087-567
    - Hospital e Maternidade Madre Theodora LTDA
  - Campinas, SP, Brazil, 13092-132
    - CENNI Oncologia
  - Santo Andre, SP, Brazil, 09060-650
    - Fundacao do ABC - FMABC/ Faculdade de Medicina ABC ( CEPHO - Centro de Estudos e Pesquisas de
  - Sao Paulo, SP, Brazil, 01506-000
    - Hospital Bandeirantes
  - Sao Paulo, SP, Brazil, 05403-000
    - Hospital das Clinicas da Faculdade de Medicina da USP / Fundacao Faculdade de Medicina MEC MPAS
  - Sao Paulo, SP, Brazil, 08270-070
    - Casa de Saude Santa Marcelina (Centro de Pesquisa Santa Marcelina)
  - São Paulo, SP, Brazil, 01242-020
    - IEP São Lucas (Pharmacy)
Croatia
- - Zagreb, Croatia, 10000
    - University hospital centre Zagreb
  - Zagreb, Croatia, 10 000
    - University Hospital Center Zagreb, Department of Nuclear Medicine and Radiation Protection
  - Zagreb, Croatia, 10 000
    - University Hospital Center Zagreb, Department of Pathology and Cytology
  - Zagreb, Croatia, 10 000
    - University Hospital Center Zagreb, Department of Radiology
  - Zagreb, Croatia, 10000
    - University Hospital Centre "Sestre Milosrdnice"
France
- - Boulogne Sur Mer, France, 62321
    - Hopital Duchenne Chu - Boulogne Sur Mer
  - Bourg En Bresse Cedex, France, 01012
    - Centre Hospitalier de Bourg en Bresse
  - Brest, France, 29609
    - Hopital Morvan-CHU Brest- Service Hematologie Clinique
  - Caen, France, 14033
    - Centre Hospitalier Universitaire Côte de Nacre
  - Le Mans, France, 72037
    - Centre Hospitalier du Mans
  - Lyon, France, 69009
    - Clinique de la Sauvegarde
- Marseille Cedex 05
  - Marseille, Marseille Cedex 05, France, 13385
    - CHU Marseille Hopital de La Conception
- Mulhouse Cedex
  - Mulhouse, Mulhouse Cedex, France, 68100
    - CH de Mulhouse, Hopital Emile Muller
- NAP
  - Boulogne Sur Mer, NAP, France, 62321
    - Hopital Duchenne Chu - Boulogne Sur Mer
Georgia
- - Tbilisi, Georgia, 0144
    - High Technology Medical Center, University Clinic
  - Tbilisi, Georgia, 0112
    - "LTD ""M. Zodelava's Hematology Centre"""
  - Tbilisi, Georgia, 0112
    - LTD "Research Institute of Clinical Medicine"
Germany
- - Berlin, Germany, 13353
    - Charité - Universitätsmedizin Berlin
  - Berlin, Germany, 12200
    - Charité - Universitaetsmedizin Berlin
  - Berlin, Germany, 12200
    - Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin
  - Berlin, Germany, 13353
    - Charite - Universitaetsmedizin Berlin, Campus Virchow-Klinikum
  - Berlin, Germany, 13353
    - Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum
  - Chemnitz, Germany, 09113
    - Klinikum Chemnitz gGmbH
  - Chemnitz, Germany, 09113
    - Klinikum Chemnitz gGmbH - Institut fuer Interventionelle Radiologie und Neuroradiologie
  - Chemnitz, Germany, 09116
    - Klinikum Chemnitz gGmbH - Klinik fuer Nuklearmedizin
  - Chemnitz, Germany, 09116
    - Klinikum Chemnitz gGmbH - Zentralapotheke
  - Essen, Germany, 45147
    - Universitaetsklinikum Essen (AoeR)
  - Essen, Germany, 45147
    - Universitätsklinikum Essen (AöR)
  - Herne, Germany, 44623
    - DokuSan Gesellschaft fuer Medizinische Studien mbH & Co. KG
  - Herne, Germany, 44649
    - Apotheke des St. Anna Hospital
  - Herne, Germany, 44651
    - EVK Eickel
  - Koeln, Germany, 50679
    - Praxis im Koeln Triangle
  - Mutlangen, Germany, 73557
    - Gemeinschaftspraxis fuer Diagnostische Radiologie und Nuklearmedizin
  - Mutlangen, Germany, 73557
    - Kliniken Ostalb, Stauferklinikum Schwaebisch Gmuend, Zentrum fuer Innere Medizin
  - Mutlangen, Germany, 73557
    - Stauferklinikum Schwaebisch Gmuend, Apotheke
  - Rostock, Germany, 18057
    - Universitaetsmedizin Rostock
  - Stuttgart, Germany, 70174
    - Klinikum Stuttgart, Klinik fuer Nuklearmedizin
  - Stuttgart, Germany, 70199
    - Vinzenz von Paul Kliniken GgmbH
  - Troisdorf, Germany, 53840
    - Radiologie Rhein-Sieg
  - Troisdorf, Germany, 53840
    - Ueberoertliche Berufsausuebungsgemeinschaft Drs. med. Helmut Forstbauer
  - Troisdorf, Germany, 53842
    - Zentralapotheke
Greece
- - Athens, Greece, 10676
    - Gen. Hosp. of Athens "Evangelismos - Eye Hosp.- Polikliniki"
  - Athens, Greece, 10676
    - Gen. Hosp. of Athens "Evangelismos-Eye Hosp. - Polikliniki"
  - Athens, Greece, 10676
    - Gen. Hosp. of Athens "Evangelismos-Eye Hosp.-Polikliniki"
  - Athens, Greece, 10676
    - Gen.Hosp.of Athens "Evangelismos-Eye Hosp.-polikiliniki"
  - Athens, Greece, 10676
    - General Hospital of Athens "Evangelismos - Eye Hosp. - Polikliniki"
  - Athens, Greece, 11526
    - Bioiatriki S.A.
  - Athens, Greece, 11526
    - Bioiatriki
  - Athens, Greece, 11527
    - General Hospital of Athens 'Laiko'
  - Athens, Greece, 12462
    - """ATTIKON"" Gen. Univ. Hosp"
  - Chaidari, Athens, Greece, 12462
    - "ATTIKON'' Gen. Univ. Hosp.
  - Patras, Greece, 26504
    - University General Hospital of Patras
  - Patras, Greece, 26222
    - Magnitiki Patron
India
- - New Delhi, India, 110 085
    - Rajiv Gandhi Cancer Institute & Research Center (RGCIRC)
- Gujarat
  - Surat, Gujarat, India, 395001
    - Super Scan Imaging Centre
  - Surat, Gujarat, India, 395002
    - Pathology Department, Unique Hospital Multispeciality & Research Institute
  - Surat, Gujarat, India, 395002
    - Zircon- BIC Imaging Centre
- Karanataka
  - Mangalore, Karanataka, India, 575002
    - Mangalore Institute of Oncology
- Karnataka
  - Bangalore, Karnataka, India, 560027
    - HealthCare Global Enterprises Limited
  - Manipal, Karnataka, India, 576104
    - Kasturba Medical College and Hospital
- Maharashtra
  - Nashik, Maharashtra, India, 422004
    - Curie Manavata Cancer Centre
  - Nashik, Maharashtra, India, 422004
    - Department of Radiology, Curie Manavata Cancer Centre
  - Pune, Maharashtra, India, 411001
    - Ruby Hall Clinic
  - Pune, Maharashtra, India, 411001
    - Department of Radiology
  - Pune, Maharashtra, India, 411001
    - Jehangir Clinical Development Centre Pvt. Ltd.
- Rajasthan
  - Jaipur, Rajasthan, India, 302004
    - R.K. Birla Cancer Center, Sawai Man Singh Hospital
- Tamilnadu
  - Chennai, Tamilnadu, India, 600035
    - Apollo Speciality Hospital
  - Chennai, Tamilnadu, India, 600035
    - Department of Radiology
- Telangana
  - Hyderabad, Telangana, India, 500 004
    - Global Hospitals
  - Hyderabad, Telangana, India, 500029
    - Vijaya Diagnostic Centre
- WEST Bengal
  - Kolkata, WEST Bengal, India, 700014
    - N.R.S Medical College and Hospital
  - Kolkata, WEST Bengal, India, 700014
    - Spandan PET-CT Unit
Italy
- - Genova, Italy, 16132
    - IRCSS A.O.U. San Martino - IST - UO Clinica Ematologica
  - Milano, Italy, 20133
    - SC Ematologia, Fondazione IRCCS Ist Nazionale dei Tumori
  - Parma, Italy, 43100
    - Padiglione 1, Torre delle medicine, 6 piano
  - Pesaro, Italy, 61122
    - Ematologia e Centro Trapianti - AZ Osp. Ospedali Riuniti Marche Nord (AORMN) - Presidio S. Salvatore
  - Pisa, Italy, 56126
    - U.O. Ematologia Universitaria - Dip. Di Oncologia dei Trapianti - AOU Pisana
  - Roma, Italy, 00128
    - Policlinico Universitario Campus Bio- Medico-U.O.C. di Ematologia Trapianto Cellule Staminali
- CR
  - Cremona, CR, Italy, 26100
    - U.O. di Ematologia e CTMO - Istituti Ospedalieri di Cremona
- FC
  - Meldola, FC, Italy, 47014
    - IRST - IRCCS U. O. Oncologia Medica
- GE
  - Genova, GE, Italy, 16132
    - U.O. Ematologia 1 - IRCCS AOU San Martino-IST
- MB
  - Monza, MB, Italy, 20900
    - Unita di Ricerca Clinica
- MI
  - Milano, MI, Italy, 20141
    - Istituto Europeo di Oncologia
- NAP
  - Latina, NAP, Italy, 04100
    - Unità semplice di Medicina Nucleare
- PG
  - Terni, PG, Italy, 05100
    - Az Ospedaliera Santa Maria
- Palermo
  - Torrette Ancona, Palermo, Italy, 60121
    - Clinica Ematologica - A.O.U. Ospedali Riuniti di Ancona
- Reggio
  - Reggio Emilia, Reggio, Italy, 42123
    - Medicina nucleare
  - Reggio Emilia, Reggio, Italy, 42123
    - Radiologia
  - Reggio Emilia, Reggio, Italy, 42123
    - SC Ematologia - SC Ematologia - Arcispedale Santa Maria Nuova - IRCCS
- Rome Rm
  - Rome, Rome Rm, Italy, 00161
    - "Dipartimento di Biotecnologie Cellulari ed Ematologia, Universita ""Sapienza""
Japan
- - Fukuoka, Japan, 811-0213
    - Fukuoka Wajiro PET Diagnostic Imaging Clinic
  - Nagano, Japan, 399-8701
    - National Hospital Organization Matsumoto Medical Center
  - Tokyo, Japan, 2080022
    - Musashimurayama Hospital
- Aichi
  - Nagoya, Aichi, Japan, 466-8650
    - Nagoya Daini Red Cross Hospital
  - Nagoya, Aichi, Japan, 464-0044
    - East Nagoya Imaging Diagnosis Center
- Akita
  - Akita City, Akita, Japan, 010-8543
    - Akita University Hospital
- Chiba
  - Chiba-shi, Chiba, Japan, 260-8717
    - Chiba cancer center
- Fukuoka
  - Fukuoka-Shi, Fukuoka, Japan, 811-1395
    - National Hospital Organization Kyushu Cancer Center
  - Fukuoka-shi, Fukuoka, Japan, 810-8563
    - National Hospital Organization Kyushu Medical Center
- Hyogo
  - Kobe-City, Hyogo, Japan, 650-0047
    - Kobe City Medical Center General Hospital
- Ishikawa
  - Kanazawa, Ishikawa, Japan, 920-8650
    - National Hospital Organization Kanazawa Medical Center
  - Kanazawa, Ishikawa, Japan, 9200934
    - Kanazawa Advanced Medical Center
- Kanagawa-ken
  - Yokohama-shi, Kanagawa-ken, Japan, 224-8503
    - Showa University Northern Yokohama Hospital
- Kochi
  - Okocho, Nankoku, Kochi, Japan, 783-8505
    - Kochi Medical School Hospital
- Kumamoto-ken
  - Kumamoto-shi, Kumamoto-ken, Japan, 860-0008
    - National Hospital Organization Kumamoto Medical Center
  - Kumamoto-shi, Kumamoto-ken, Japan, 862-0941
    - Uozumi Clinic
- Miyagi
  - Sendai-shi, Miyagi, Japan, 983-8520
    - National Hospital Organization Sendai Medical Center
  - Sendai-shi, Miyagi, Japan, 980-0873
    - Sendai Kousei Hospital
- Nagano
  - Matsumoto-shi, Nagano, Japan, 390-8510
    - Aizawa Hospital
  - Nagano-shi, Nagano, Japan, 380-8582
    - Nagano Red Cross Hospital
- Nagasaki
  - Omura, Nagasaki, Japan, 856-8562
    - National Hospital Organization Nagasaki Medical Center
- Osaka
  - Kawachinagano, Osaka, Japan, 586-8521
    - National Hospital Organization Osaka Minami Medical Center
  - Naka-ku Sakai, Osaka, Japan, 599-8271
    - Hanwa Dai 2 Senboku Hospital
  - Osaka-City, Osaka, Japan, 545-8586
    - Osaka City University Hospital
- Tokushima
  - Tokushima-Shi, Tokushima, Japan, 770-8503
    - Tokushima University Hospital
- Tokyo
  - Meguro-Ku, Tokyo, Japan, 152-8902
    - National Hospital Organization Tokyo Medical Center
  - Shinagawa-ku, Tokyo, Japan, 142-8666
    - Showa University Hospital
  - Tachikawa, Tokyo, Japan, 190-0014
    - National Hospital Organization Disaster Medical Center
- Yamagata
  - Yamagata-Shi, Yamagata, Japan, 990-9585
    - Yamagata University Hospital
Korea, Republic of
- - Busan, Korea, Republic of, 47392
    - Inje University Busan Paik Hospital
  - Seoul, Korea, Republic of, 03080
    - Seoul National University Hospital
  - Seoul, Korea, Republic of, 06351
    - Samsung Medical Center
- Gyeonggi-do
  - Anyang-si, Gyeonggi-do, Korea, Republic of, 14068
    - Hallym University Sacred Heart Hospital
  - Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
    - Seoul National University Bundang Hospital
- Jeollabuk-do
  - Jeonju-si, Jeollabuk-do, Korea, Republic of, 54907
    - Chonbuk National University Hospital
- Korea
  - Ulsan, Korea, Korea, Republic of, 44033
    - Ulsan University Hospital
Lebanon
- - Beirut, Lebanon
    - Doctors Center Radiology
  - Beirut, Lebanon
    - Mount Lebanon Hospital
  - El Metn, Lebanon
    - Middle East Institute Of Health
  - Mount Lebanon, Lebanon
    - Ain Wazein Hospital
- Southern Governate
  - Saida, Southern Governate, Lebanon
    - Hammoud Hospital, University Medical Center
Mexico
- - Oaxaca, Mexico, 68000
    - Oaxaca Site Management Organization S.C.
  - Oaxaca, Mexico, 68000
    - Cirurgia y Ginecobstetricia de Oaxaca, S.A de C.V.
  - Puebla, Mexico, 72190
    - Hospital Angeles Puebla
  - Queretaro, Mexico, 76090
    - Cancerologia de Queretaro S.C.
  - Queretaro, Mexico, 76140
    - Hospital Infantil Teleton de Oncologia
  - Queretaro, Mexico, 76158
    - Hospital San Jose Norte
- Distrito Federal
  - Mexico City, Distrito Federal, Mexico, 03310
    - Grupo Médico Camino S.C.
  - Mexico City, Distrito Federal, Mexico, 03340
    - Imagenus
  - Mexico City, Distrito Federal, Mexico, 06700
    - Isos Pharmacorp, S.A. de C.V.
- Estado DE Mexico
  - Cuautitlan Izacalli, Estado DE Mexico, Mexico, 54750
    - Vely Grupo Medico Quirurgico, S.A. de C.V.
  - Cuautitlan Izcalli, Estado DE Mexico, Mexico, 54769
    - Phylasis Clinicas Research S. de R.L. de C.V.
- Nuevo LEON
  - Monterrey, Nuevo LEON, Mexico, 64460
    - Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
  - Monterrey, Nuevo LEON, Mexico, 64460
    - Centro Universitario de Imagen Diagnostica, Radiologia e Imagen del Hospital Universitario
Peru
- - Lima, Peru, 18
    - Pet Scan Peru
  - Lima, Peru, 18
    - Resocentro
- Lima
  - Surquillo, Lima, Peru, 34
    - Instituto Nacional de Enfermedades Neoplasicas
Philippines
- - Quezon City, Philippines, 1102
    - St. Luke's Medical Center
- Metro Manila
  - Manila, Metro Manila, Philippines, 1000
    - University of Philippines Manila-Philippine General Hospital
Poland
- - Warszawa, Poland, 02-781
    - Klinika Nowotworow Ukladu Chlonnego Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie
  - Wroclaw, Poland, 50-420
    - Euromedic Wroclawskie Centrum Medyczne II
  - Wroclaw, Poland, 50-557
    - Euromedic Wroclawskie Centrum Medyczne III
  - Wroclaw, Poland, 53-439
    - Dolnośląskie Centrum Transplantacji Komórkowych z Krajowym Bankiem Dawców Szpiku
  - Wroclaw, Poland, 53-439
    - Euromedic Wroclawskie Centrum Medyczne I
  - Wroclaw, Poland, 54-424
    - Apteka Dolnoslaskiego Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku
Portugal
- - Braga, Portugal, 4710-243
    - Hospital de Braga
  - Lisboa, Portugal, 1998-018
    - Hospital CUF Descobertas
  - Porto, Portugal, 4050-075
    - CIMC
  - Porto, Portugal, 4050-075
    - Dr. Campos Costa Clinic
  - Porto, Portugal, 4099 - 001
    - Centro Hospitalar do Porto-Hospital de Santo Antonio E.P.E.
  - Porto, Portugal, 4200-072
    - Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E
  - Vila Nova de Gaia, Portugal, 4434-502
    - Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
- Porto
  - Matosinhos, Porto, Portugal, 4464-513
    - Unidade Local de Saude de Matosinhos E.P.E. - Hospital Pedro Hispano S.A.
Puerto Rico
- - Coto Laurel, Puerto Rico, 00780
    - Modern Radiology, PSC
  - Ponce, Puerto Rico, 00717
    - Ad-Vance Medical Research, LLC
  - Ponce, Puerto Rico, 00717
    - Caribe MRI and CT
Romania
- - Brasov, Romania, 500152
    - Policlinica de Diagnostic Rapid, Hematologie
  - Brasov, Romania, 500366
    - Policlinica de Diagnostic Rapid SA
  - Bucuresti, Romania, 030171
    - Spitalul Clinic Coltea, Clinica de Hematologie
  - Bucuresti, Romania, 020125
    - Spitalul Clinic Colentina
  - Bucuresti, Romania, 021675
    - Hiperdia Ritmului
  - Bucuresti, Romania, 022328
    - Affidea Fundeni
  - Bucuresti, Romania, 022328
    - Affidea Romania SRL
  - Cluj-Napoca, Romania, 400015
    - Institutul Oncologic Prof. Dr. Ion Chiricuta, Laborator Radiologie si Imagistica Medicala
  - Cluj-Napoca, Romania, 400015
    - Institutul Oncologic Prof. Dr. Ion Chiricuta, Sectia Oncologie Medicala
  - Cluj-Napoca, Romania, 400124
    - Clinica de Hematologie-Institutul Oncologic, Prof. Dr. Ion Chiricuta
  - Cluj-Napoca, Romania, 400489
    - CT Clinic S.R.L.
Russian Federation
- - Chelyabinsk, Russian Federation, 454087
    - "State Budget Healthcare Institution ""Chelyabinsk Regional Clinical Center of Oncology
  - Moscow, Russian Federation, 121309
    - LLC "Vitamed"
  - Moscow, Russian Federation, 115478
    - FSBSI 'N.N.Blokhin Russian Cancer Research Center' of MoH of RF
  - Moscow, Russian Federation, 115478
    - Russian Cancer Research Centre them N.N. Blokhin
  - Moscow, Russian Federation, 125284
    - SBHI of Moscow City Clinical Hospital n.a. S.P.Botkin of Healthcare Department of Moscow
  - Moscow, Russian Federation, 127473
    - Ramsay Diagnostics
  - Saint Petersburg, Russian Federation, 194291
    - State Budgetary Institution of Healthcare "Leningrad Regional Clinical Hospital"
  - Saint-Petersburg, Russian Federation, 194214
    - Dr. Berezin Medical Institute
  - Saint-Petersburg, Russian Federation, 197376
    - N.P. Bechtereva Institute of Human Brain of the Russian Academy of Sciences
  - Saint-Petersburg, Russian Federation, 197376
    - N.P. Bechtereva Institute of the Human Brain of the Russian Academy of Sciences
  - Saint-Petersurg, Russian Federation, 195271
    - Non-state healthcare institution "Road Clinical Hospital of Joint Stock Company "Russian Railways"
  - Yaroslavl, Russian Federation, 150010
    - Yaroslavl State Medical Academy
  - Yaroslavl, Russian Federation, 150062
    - GBUZ of Yaroslavl Region "Regional Clinical Hospital"
- Kaluga Region
  - Obninsk, Kaluga Region, Russian Federation, 249036
    - A.Tsyb Medical Radiological Research Centre -
- Mordovian Republic
  - Saransk, Mordovian Republic, Russian Federation, 430032
    - State Healthcare Institution Republican Oncology Dispensary
- Nizhniy Novgorod Region
  - Nizhniy Novgorod, Nizhniy Novgorod Region, Russian Federation, 603126
    - "SBHI of NNR ""Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko"""
  - Nizhniy Novgorod, Nizhniy Novgorod Region, Russian Federation, 603126
    - LLC MC "MRT-Diagnostika"
- Pesochniy
  - Saint-Petersburg, Pesochniy, Russian Federation, 197758
    - FSBI "Russian Research Centre of Radiology and Surgical Technologies n.a. A.M. Granov" of MoH of RF
  - Saint-Petersburg, Pesochniy, Russian Federation, 197758
    - FSBI "Russian Research Centre of Radiology and Surgical Technologies named after academician
  - Saint-Petersburg, Pesochniy, Russian Federation, 197758
    - FSBI "Russian Research Centre of Radiology and Surgical Technologies
- Pesochniy TOWN
  - Saint-Petersburg, Pesochniy TOWN, Russian Federation, 197758
    - FSBI "Russian Research Centre of Radiology and Surgical Technologies" of MoH of RF
  - Saint-Petersburg, Pesochniy TOWN, Russian Federation, 197758
    - FSBI "Russian Research Centre of Radiology and Surgical Technologies"
  - Saint-Petersburg, Pesochniy TOWN, Russian Federation, 197758
    - FSBI "Russian Research Centre of Radiology and Surgical Technologies
  - Saint-Petersburg, Pesochniy TOWN, Russian Federation, 197758
    - FSBI 'Russian Research Centre of Radiology and Surgical Technologies
- Pos.pesochny
  - Saint-Petersburg, Pos.pesochny, Russian Federation, 197758
    - FSBI 'National Medical Oncology Research Centre n.a. N.N.Petrov'
- Republic Bashkortostan
  - Ufa, Republic Bashkortostan, Russian Federation, 450054
    - Branch office of LLC 'PET-Technology' at Ufa city
  - Ufa, Republic Bashkortostan, Russian Federation, 450054
    - State Budgetary Healthcare Institution "Republican Clinical Oncology Dispensary of the Ministry
- Saint Petersburg
  - Pushkin, Saint Petersburg, Russian Federation, 196603
    - Private Medical Institution "Euromedservice"
- Saint-petersburg
  - Pesochniy Town, Saint-petersburg, Russian Federation, 197758
    - FSBI "Russian Research Centre of Radiology and Surgical Technologies" of MoH of RF
- Stavropol Region
  - Lermontov, Stavropol Region, Russian Federation, 357340
    - Federal State-Financed Institution 'North-Caucasian Research and Clinical Center'
  - Pyatigorsk, Stavropol Region, Russian Federation, 357502
    - SBHI of Stavropol Region "Pyatigorsk Interdistrict Oncology Dispensary
South Africa
- Gauteng
  - Groenkloof, Gauteng, South Africa, 0181
    - NIKSCH & PARTNERS t/a CAPITAL RADIOLOGY
  - Johannesburg, Gauteng, South Africa, 2196
    - The Medical Oncology Centre of Rosebank
  - Pretoria, Gauteng, South Africa, 0002
    - Department of Medical Oncology, University of Pretoria, Steve Biko Academic Hospitals Complex
  - Pretoria, Gauteng, South Africa, 0044
    - Albert Alberts Stem Cell Transplant Centre
  - Pretoria, Gauteng, South Africa, 0044
    - Dr JN De Jong and Partners t/a East Rad
  - Pretoria, Gauteng, South Africa, 0181
    - NIKSCH & PARTNERS t/a CAPITAL RADIOLOGY
  - Rosebank, Gauteng, South Africa, 2196
    - Drs Sulman & Partners Specialist Radiologists
  - Sandton, Gauteng, South Africa, 2191
    - Drs Bloch & Partners Incorporated
Spain
- - A Coruna, Spain, 15006
    - Complejo Hospitalario Universitario A Coruna
  - A Coruna, Spain, 15011
    - Hospital Modelo
  - Barcelona, Spain, 08003
    - Hospital del Mar
  - Barcelona, Spain, 08012
    - Hospital Quiron de Barcelona, IEC
  - Barcelona, Spain, 08029
    - CETIR, Centre Medic
  - Barcelona, Spain, 08029
    - Radiodiagnostic CETIR - Clinica del Pilar
  - Cadiz, Spain, 11009
    - Hospital Universitario Puerta del Mar
  - Madrid, Spain, 28040
    - Hospital Universitario Fundacion Jimenez Diaz
  - Madrid, Spain, 28050
    - Hospital Universitario Sanitas La Moraleja
  - Malaga, Spain, 29010
    - Hospital Universitario Virgen de La Victoria
  - Malaga, Spain, 29010
    - Centro CIMES
  - Malaga, Spain, 29016
    - Centro Mario Gallegos
  - Ourense, Spain, 32005
    - Complejo Hospitalario de Ourense. Hematología
  - Sevilla, Spain, 41013
    - Hospital Universitario Virgen del Rocio
  - Zaragoza, Spain, 50012
    - Hospital de Dia Quiron Zaragoza
  - Zaragoza, Spain, 50006
    - H. Quirón Zaragoza
- Barcelona
  - Sabadell, Barcelona, Spain, 08208
    - Hospital Parc Taulí
- Guipuzcoa
  - San Sebastian, Guipuzcoa, Spain, 20014
    - Onkologikoa
- Madrid
  - Aravaca, Madrid, Spain, 28023
    - Hospital Universitario Sanitas la Zarzuela
  - Mostoles, Madrid, Spain, 28933
    - Hospital Rey Juan Carlos
- Murcia
  - El Palmar, Murcia, Spain, 30120
    - Hospital Clínico Universitario Virgen de la Arrixaca
- Pontevedra
  - Vigo, Pontevedra, Spain, 36200
    - Hospital do Meixoeiro Complejo Hospitalario Universitario de Vigo
Switzerland
- - Basel, Switzerland, 4031
    - Universitätsspital Basel
  - Bern, Switzerland, 3010
    - Inselspital Bern
  - Thun, Switzerland, 3600
    - Apotheke, Spital STS AG
  - Thun, Switzerland, 3600
    - Onkologiezentrum Thun-Berner Oberland Spital Sts Ag
  - Zuerich, Switzerland, 8091
    - Universitaetsspital Zuerich
  - Zuerich, Switzerland, 8006
    - Kantonsapotheke Zuerich
Thailand
- - Bangkok, Thailand, 10400
    - National Cancer Institute
  - Bangkok, Thailand, 10400
    - Cardiology Unit,Department of Medicine, Faculty of Medicine, Ramathibodi Hospital,
  - Bangkok, Thailand, 10400
    - Department of Radiology, Ramathibodi Hospital
Turkey
- - Ankara, Turkey, 06100
    - Hacettepe Universitesi Tip Fakultesi Onkoloji Hastanesi
  - Ankara, Turkey, 06200
    - Dr. Abdurrahman Yurtaslan Ankara Onkoloji Eg. ve Aras.
  - Ankara, Turkey, 06420
    - Ultramar Tibbi Gorunteleme Merkezi
  - Ankara, Turkey, 06420
    - Ultramar Tibbi Goruntuleme Merkezi
  - Ankara, Turkey, 06540
    - Integra Gurses Teshis Tedavi ve Saglik Hizmetleri A.S.
  - Aydin, Turkey, 09010
    - Adnan Menderes University Medical Faculty
  - Gaziantep, Turkey, 27310
    - Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi
  - Gaziantep, Turkey, 27310
    - Gaziantep Universitesi Sahinbey Arastirma ve Uygulama
  - Istanbul, Turkey, 34093
    - Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
  - Izmir, Turkey, 35040
    - Ege Universitesi Tip Fakultesi Ic Hastaliklari Anabilim Dali
  - Izmir, Turkey, 35040
    - EGE-RAD Bilgisayarli Tomografi Ozel Saglik Hizmetleri ve Malzemeleri Tic.Ltd.Sti.
  - Kayseri, Turkey, 38100
    - Erciyes Universitesi Tip Fakultesi Nukleer Tip Laboratuvari
  - Kayseri, Turkey, 38100
    - Erciyes Universitesi Tip Fakultesi Radyoloji Laboratuvari
  - Kayseri, Turkey, 38100
    - Erciyes Universitesi Tip Fakultesi
  - Malatya, Turkey, 44280
    - Inonu Universitesi Tip Fakultesi Turgut Ozal Tip Merkezi
  - Manisa, Turkey, 45000
    - Celal Bayar University Medical Faculty
  - Samsun, Turkey, 55139
    - Ondokuz Mayis Universitesi Tip Fakultesi
Ukraine
- - Chernivtsi, Ukraine, 58013
    - "Municipal Institution ""Chernivtsi Regional Clinical Oncology Center"",
  - Dnipropetrovsk, Ukraine, 49102
    - MI 'City Dnipropetrovsk Multi-field Clin. Hospital #4 of DRC',
  - Kharkiv, Ukraine, 61070
    - Municipal Non-Profit Enterprise "Regional Oncology Centre"
  - Kyiv, Ukraine, 03022
    - National Cancer Institute
  - Uzhhorod, Ukraine, 88017
    - "Central City Clinical Hospital, City Oncology Center, SHEI ""Uzhhorod National University"", Chair
  - Vinnytsia, Ukraine, 21029
    - Podilskyy Regional Oncology Center, Chemotherapy Department
  - Zaporizhzhia, Ukraine, 69040
    - Municipal Establishment 'Zaporizhzhia Regional Clinical Oncology Dispensary'
  - Zaporizhzhia, Ukraine, 69076
    - LLC "Diaservis"
- KYIV Region
  - Obukhiv, KYIV Region, Ukraine, 08720
    - "MedX-Ray International Group" LLC
  - Obukhiv District, KYIV Region, Ukraine, 08720
    - "Mediks-rey International Group" LLC
  - Obukhiv District, KYIV Region, Ukraine, 08720
    - "MedX-rey International Group" LLC
United Kingdom
- - Bath, United Kingdom, BA1 3NG
    - Royal United Hospitals Bath NHS Foundation Trust
  - London, United Kingdom, EC1A 7BE
    - Barts Health NHS Trust
  - Newcastle upon Tyne, United Kingdom, NE4 6BE
    - Positron Emission Tomography (PET) Centre
  - Sunderland, United Kingdom, SR4 7TP
    - City Hospitals Sunderland NHS Foundation Trust-Sunderland Royal Hospital
  - Sunderland, United Kingdom, SR4 7TP
    - Diagnostic Imaging
- Essex
  - Westcliff-On-Sea, Essex, United Kingdom, SS0 0RY
    - Southend University Hospital NHS Foundation Trust
- Glos.
  - Cheltenham, Glos., United Kingdom, GL53 7AS
    - Cobalt Diagnostic Imaging
United States
- California
  - Anaheim, California, United States, 92801
    - Pacific Cancer Medical Center, Inc.
  - Anaheim, California, United States, 92801
    - The Oncology Institute of Hope and Innovation
  - Corona, California, United States, 92879
    - Compassionate Care Research Group, Inc., at Compassionate Cancer Care Medical Group, Inc.
  - Downey, California, United States, 90241
    - The Oncology Institute of Hope and Innovation
  - Fountain Valley, California, United States, 92708
    - Compassionate Care Research Group, Inc., at Compassionate Cancer Care Medical Group, Inc.
  - Gilroy, California, United States, 95020
    - Global Cancer Research Institute (GCRI), Inc
  - Gilroy, California, United States, 95020
    - Saint Louise Regional Hospital Radiology Department (Radiology Only)
  - Gilroy, California, United States, 95020
    - South Valley Imaging Center (Imaging Only)
  - Glendale, California, United States, 91204
    - Los Angeles Hematology Oncology Medical Group
  - Glendale, California, United States, 91204
    - The Oncology Institute of Hope and Innovation
  - Glendale, California, United States, 91206
    - Los Angeles Hematology Oncology Medical Group
  - Long Beach, California, United States, 90805
    - The Oncology Institute of Hope and Innovation
  - Los Angeles, California, United States, 90017
    - Los Angeles Hematology Oncology Medical Group
  - Los Angeles, California, United States, 90057
    - Los Angeles Hematology Oncology Medical Group
  - Lynwood, California, United States, 90262
    - The Oncology Institute of Hope and Innovation
  - Montebello, California, United States, 90640
    - The Oncology Institute of Hope and Innovation
  - Palm Springs, California, United States, 92262
    - Comprehensive Cancer Center at Desert Regional Medical Center
  - Redondo Beach, California, United States, 90277
    - Torrance Health Association DBA, Torrance Memorial Physician, Network/Cancer Care Associates
  - Riverside, California, United States, 92501
    - Compassionate Care Research Group, Inc., at Compassionate Cancer Care Medical Group, Inc.
  - San Jose, California, United States, 95128
    - O'Connor Hospital
  - San Jose, California, United States, 95124
    - Global Cancer Research Institute, Inc.
  - San Jose, California, United States, 95128
    - PET Imaging of San Jose (Imaging Only)
  - Santa Ana, California, United States, 92705
    - The Oncology Institute of Hope and Innovation
  - Torrance, California, United States, 90505
    - Torrance Memorial Medical Center
  - Whittier, California, United States, 90603
    - Innovative Clinical Research Institute (ICRI)
  - Whittier, California, United States, 90602
    - The Oncology Institute of Hope and Innovation
- Colorado
  - Aurora, Colorado, United States, 80012
    - Rocky Mountain Cancer Centers
  - Boulder, Colorado, United States, 80303
    - Rocky Mountain Cancer Centers
  - Denver, Colorado, United States, 80218
    - Rocky Mountain Cancer Centers
  - Lakewood, Colorado, United States, 80228
    - Rocky Mountain Cancer Center-Lakewood (Laboratory)
  - Lakewood, Colorado, United States, 80228
    - Rocky Mountain Cancer Centers (RMCC) - Lakewood - St Anthony
  - Lone Tree, Colorado, United States, 80124
    - Rocky Mountain Cancer Centers
  - Pueblo, Colorado, United States, 81008
    - Rocky Mountain Cancer Center Pueblo
- Georgia
  - Thomasville, Georgia, United States, 31792
    - John D. Archbold Memorial Hospital
  - Thomasville, Georgia, United States, 31792
    - Lewis Hall Singletary Oncology Center at John D. Archbold Memorial Hospital
- Illinois
  - DeKalb, Illinois, United States, 60115
    - Northwestern Medicine West Region
  - Geneva, Illinois, United States, 60134
    - Cancer Center,Northwestern Medicine, West Region
- Kansas
  - Chanute, Kansas, United States, 66720
    - Cancer Center of Kansas
  - Dodge City, Kansas, United States, 67801
    - Cancer Center of Kansas
  - El Dorado, Kansas, United States, 67042
    - Cancer Center of Kansas
  - Independence, Kansas, United States, 67301
    - Cancer Center of Kansas
  - Kingman, Kansas, United States, 67068
    - Cancer Center of Kansas
  - Liberal, Kansas, United States, 67905
    - Cancer Center of Kansas
  - McPherson, Kansas, United States, 67460
    - Cancer Center of Kansas
  - Newton, Kansas, United States, 67114
    - Cancer Center of Kansas
  - Overland Park, Kansas, United States, 66210
    - The University of Kansas Cancer Center
  - Parsons, Kansas, United States, 67357
    - Cancer Center of Kansas
  - Salina, Kansas, United States, 67401
    - Cancer Center of Kansas
  - Wellington, Kansas, United States, 67152
    - Cancer Center of Kansas
  - Wichita, Kansas, United States, 67214
    - Cancer Center of Kansas
  - Wichita, Kansas, United States, 67208
    - Cancer Center of Kansas
  - Winfield, Kansas, United States, 67156
    - Cancer Center of Kansas
- Maryland
  - Baltimore, Maryland, United States, 21229
    - Saint Agnes Hospital
  - Baltimore, Maryland, United States, 21229
    - PET/CT facility Seton Imaging Center
  - Bethesda, Maryland, United States, 20817
    - Rcca Md Llc
  - Silver Spring, Maryland, United States, 20910
    - Holy Cross Hospital
  - Silver Spring, Maryland, United States, 20902
    - Holy Cross Hospital Resource Center
  - Silver Spring, Maryland, United States, 20910
    - Holy Cross Hospital Hospital Pharmacy
  - Wheaton, Maryland, United States, 20902
    - Maryland Oncology Hematology, P.A.
- Missouri
  - Kansas City, Missouri, United States, 64131
    - The University of Kansas Cancer Center
  - Kansas City, Missouri, United States, 64154
    - The University of Kansas Cancer Center
  - Lee's Summit, Missouri, United States, 64064
    - The University of Kansas Cancer Center
- Nebraska
  - Grand Island, Nebraska, United States, 68803
    - Saint Francis Medical Center, Saint Francis Cancer Treatment Center
  - Grand Island, Nebraska, United States, 68803
    - Saint Francis Medical Center
  - Hastings, Nebraska, United States, 68901
    - Saint Francis Medical Center, Saint Francis Cancer Treatment Center
- Nevada
  - Henderson, Nevada, United States, 89074
    - Comprehensive Cancer Centers of Nevada
  - Henderson, Nevada, United States, 89052
    - Comprehensive Cancer Centers of Nevada
  - Las Vegas, Nevada, United States, 89148
    - Comprehensive Cancer Centers of Nevada
  - Las Vegas, Nevada, United States, 89128
    - Comprehensive Cancer Centers of Nevada
  - Las Vegas, Nevada, United States, 89169
    - Comprehensive Cancer Centers of Nevada
- North Carolina
  - Greenville, North Carolina, United States, 27834
    - Vidant Medical Center
  - Greenville, North Carolina, United States, 27834
    - Brody School of Medicine at East Carolina University
  - Greenville, North Carolina, United States, 27834
    - Vidant Medical Center Pharmacy
- Ohio
  - Maumee, Ohio, United States, 43537
    - Toledo Clinic Cancer Center - Maumee
  - Toledo, Ohio, United States, 43623
    - Toledo Clinic Cancer Center - Toledo
  - Toledo, Ohio, United States, 43623
    - Toledo Clinic, Inc.
- Oregon
  - Eugene, Oregon, United States, 97401
    - Willamette Valley Cancer Institute and Research Center
- Tennessee
  - Knoxville, Tennessee, United States, 37920
    - University of Tennessee Medical Center
- Texas
  - Fort Sam Houston, Texas, United States, 78234
    - San Antonio Military Medical Center
  - Fort Sam Houston, Texas, United States, 78234
    - San Antonio Military Medical Center- Department of Pharmacy
  - Fort Sam Houston, Texas, United States, 78234
    - San Antonio Military Medical Center- Department of Radiology
  - Fort Worth, Texas, United States, 76177
    - Investigational Products Center (IPC)
  - Fort Worth, Texas, United States, 76177
    - Investigational Products Center (I PC)
  - Houston, Texas, United States, 77090
    - Millennium Oncology
  - Irving, Texas, United States, 75063
    - US Oncology Investigational Products Center (IPC)
  - Kingwood, Texas, United States, 77339
    - Millennium Oncology
  - Longview, Texas, United States, 75601
    - Texas Oncology - Longview Cancer Center
  - Shenandoah, Texas, United States, 77384
    - Millennium Oncology
  - The Woodlands, Texas, United States, 77380
    - Millennium Oncology
  - Tyler, Texas, United States, 75702
    - Texas Oncology-Tyler
- Washington
  - Yakima, Washington, United States, 98902
    - Yakima Valley Memorial Hospital/North Star Lodge Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PF-05280586	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
Active Comparator: MabThera®	Biological: MabThera® MabThera® (rituximab-EU) concentrate for solution for infusion 375mg/m2 administered via IV infusion on Days 1, 8, 15, and 22

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response Rate (ORR): Percentage of Participants With Overall Response (OR) at Week 26 Time Frame: 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Time Frame: Baseline up to Week 52	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
Number of Participants With Treatment Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Time Frame: Baseline up to Week 52	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
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 Time Frame: Baseline up to Week 52	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
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 Time Frame: Baseline up to Week 52	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
Number of Participants With Clinically Significant Laboratory Abnormalities Time Frame: Baseline up to Week 52	Criteria for clinically significant laboratory abnormalities included total bilirubin (TB) less than (<) 2upper limit of normal (ULN), alanine aminotransferase (ALT)<3ULN; TB<2ULN, ALT more than (>) 3 equal to (=) ULN; TB<2ULN, aspartate aminotransferase (AST)<3ULN; TB<2ULN, AST>=3ULN. Data for only those categories are reported for which at least one participant had clinically significant laboratory abnormality.	Baseline up to Week 52
Time to Treatment Failure (TTF) Time Frame: From randomization until disease progression, death or permanent discontinuation from treatment/study due to any reason, or up to Week 52	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
Progression-Free Survival (PFS) Time Frame: From randomization until disease progression or death due to any cause or up to Week 52	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
Percentage of Participants With Complete Remission (CR) at Week 26 Time Frame: 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
Duration of Response (DOR) Time Frame: 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	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
Overall Survival Time Frame: From randomization until death due to any cause or up to Week 52	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
Maximum Observed Serum Concentration (Cmax) of PF-05280586 and Rituximab-EU Time Frame: 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		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
Minimum Observed (Trough) Serum Concentration (Ctrough) of PF-05280586 and Rituximab-EU Time Frame: Predose (within 4 hours prior to the start of dosing) on Day 1, 8, 15, and 22		Predose (within 4 hours prior to the start of dosing) on Day 1, 8, 15, and 22
Cluster of Differentiation (CD) 19-Positive B-Cell Counts Time Frame: Baseline, Week 2, 3, 4, 5, 13, 26, 39, 52		Baseline, Week 2, 3, 4, 5, 13, 26, 39, 52
Number of Participants With Positive Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) Time Frame: Baseline up to Week 52	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
Number of Participants Reporting Immune-Based Adverse Effects Time Frame: Baseline up to Week 52	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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

To obtain contact information for a study center near you, click here.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2014

Primary Completion (Actual)

October 23, 2017

Study Completion (Actual)

April 19, 2018

Study Registration Dates

First Submitted

August 7, 2014

First Submitted That Met QC Criteria

August 7, 2014

First Posted (Estimate)

August 11, 2014

Study Record Updates

Last Update Posted (Actual)

June 20, 2019

Last Update Submitted That Met QC Criteria

June 18, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

B3281006
2014-000132-41 (EudraCT Number)
REFLECTIONS (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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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)

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

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

General Publications

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description