AzTrials
AzTrials

Follicular LymphomaPhase 3NCT02213263

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 study testing PF-05280586 and MabThera® in people with Follicular Lymphoma, run by Pfizer at 423 sites in 30 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Follicular Lymphoma
What is being tested?
PF-05280586 and MabThera®
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
394 participants
Where
423 sitesin 30 countries
Study dates
30 Sep 2014to 19 Apr 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Confirmed diagnosis of low tumor burden, CD20-positive follicular lymphoma
  • Ann Arbor Stage II, III, or IV

Who cannot join

  • 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

Trial locations and contacts

423 sites in 30 countries.

423 sites in 30 countries

United States91 sites

  • Pacific Cancer Medical Center, Inc.

    Anaheim, California, 92801

  • The Oncology Institute of Hope and Innovation

    Anaheim, California, 92801

  • Rocky Mountain Cancer Centers

    Aurora, Colorado, 80012

  • PET/CT facility Seton Imaging Center

    Baltimore, Maryland, 21229

  • Saint Agnes Hospital

    Baltimore, Maryland, 21229

  • Rcca Md Llc

    Bethesda, Maryland, 20817

  • Rocky Mountain Cancer Centers

    Boulder, Colorado, 80303

  • Cancer Center of Kansas

    Chanute, Kansas, 66720

  • Compassionate Care Research Group, Inc., at Compassionate Cancer Care Medical Group, Inc.

    Corona, California, 92879

  • Northwestern Medicine West Region

    DeKalb, Illinois, 60115

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80218

  • Cancer Center of Kansas

    Dodge City, Kansas, 67801

  • The Oncology Institute of Hope and Innovation

    Downey, California, 90241

  • Cancer Center of Kansas

    El Dorado, Kansas, 67042

  • Willamette Valley Cancer Institute and Research Center

    Eugene, Oregon, 97401

  • San Antonio Military Medical Center- Department of Pharmacy

    Fort Sam Houston, Texas, 78234

  • San Antonio Military Medical Center- Department of Radiology

    Fort Sam Houston, Texas, 78234

  • San Antonio Military Medical Center

    Fort Sam Houston, Texas, 78234

  • Investigational Products Center (I PC)

    Fort Worth, Texas, 76177

  • Investigational Products Center (IPC)

    Fort Worth, Texas, 76177

  • Compassionate Care Research Group, Inc., at Compassionate Cancer Care Medical Group, Inc.

    Fountain Valley, California, 92708

  • Cancer Center,Northwestern Medicine, West Region

    Geneva, Illinois, 60134

  • Global Cancer Research Institute (GCRI), Inc

    Gilroy, California, 95020

  • Saint Louise Regional Hospital Radiology Department (Radiology Only)

    Gilroy, California, 95020

  • South Valley Imaging Center (Imaging Only)

    Gilroy, California, 95020

  • Los Angeles Hematology Oncology Medical Group

    Glendale, California, 91204

  • The Oncology Institute of Hope and Innovation

    Glendale, California, 91204

  • Los Angeles Hematology Oncology Medical Group

    Glendale, California, 91206

  • Saint Francis Medical Center, Saint Francis Cancer Treatment Center

    Grand Island, Nebraska, 68803

  • Saint Francis Medical Center

    Grand Island, Nebraska, 68803

  • Brody School of Medicine at East Carolina University

    Greenville, North Carolina, 27834

  • Vidant Medical Center Pharmacy

    Greenville, North Carolina, 27834

  • Vidant Medical Center

    Greenville, North Carolina, 27834

  • Saint Francis Medical Center, Saint Francis Cancer Treatment Center

    Hastings, Nebraska, 68901

  • Comprehensive Cancer Centers of Nevada

    Henderson, Nevada, 89052

  • Comprehensive Cancer Centers of Nevada

    Henderson, Nevada, 89074

  • Millennium Oncology

    Houston, Texas, 77090

  • Cancer Center of Kansas

    Independence, Kansas, 67301

  • US Oncology Investigational Products Center (IPC)

    Irving, Texas, 75063

  • The University of Kansas Cancer Center

    Kansas City, Missouri, 64131

  • The University of Kansas Cancer Center

    Kansas City, Missouri, 64154

  • Cancer Center of Kansas

    Kingman, Kansas, 67068

  • Millennium Oncology

    Kingwood, Texas, 77339

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

  • Rocky Mountain Cancer Center-Lakewood (Laboratory)

    Lakewood, Colorado, 80228

  • Rocky Mountain Cancer Centers (RMCC) - Lakewood - St Anthony

    Lakewood, Colorado, 80228

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89128

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89148

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169

  • The University of Kansas Cancer Center

    Lee's Summit, Missouri, 64064

  • Cancer Center of Kansas

    Liberal, Kansas, 67905

  • Rocky Mountain Cancer Centers

    Lone Tree, Colorado, 80124

  • The Oncology Institute of Hope and Innovation

    Long Beach, California, 90805

  • Texas Oncology - Longview Cancer Center

    Longview, Texas, 75601

  • Los Angeles Hematology Oncology Medical Group

    Los Angeles, California, 90017

  • Los Angeles Hematology Oncology Medical Group

    Los Angeles, California, 90057

  • The Oncology Institute of Hope and Innovation

    Lynwood, California, 90262

  • Toledo Clinic Cancer Center - Maumee

    Maumee, Ohio, 43537

  • Cancer Center of Kansas

    McPherson, Kansas, 67460

  • The Oncology Institute of Hope and Innovation

    Montebello, California, 90640

  • Cancer Center of Kansas

    Newton, Kansas, 67114

  • The University of Kansas Cancer Center

    Overland Park, Kansas, 66210

  • Comprehensive Cancer Center at Desert Regional Medical Center

    Palm Springs, California, 92262

  • Cancer Center of Kansas

    Parsons, Kansas, 67357

  • Rocky Mountain Cancer Center Pueblo

    Pueblo, Colorado, 81008

  • Torrance Health Association DBA, Torrance Memorial Physician, Network/Cancer Care Associates

    Redondo Beach, California, 90277

  • Compassionate Care Research Group, Inc., at Compassionate Cancer Care Medical Group, Inc.

    Riverside, California, 92501

  • Cancer Center of Kansas

    Salina, Kansas, 67401

  • Global Cancer Research Institute, Inc.

    San Jose, California, 95124

  • O'Connor Hospital

    San Jose, California, 95128

  • PET Imaging of San Jose (Imaging Only)

    San Jose, California, 95128

  • The Oncology Institute of Hope and Innovation

    Santa Ana, California, 92705

  • Millennium Oncology

    Shenandoah, Texas, 77384

  • Holy Cross Hospital Resource Center

    Silver Spring, Maryland, 20902

  • Holy Cross Hospital Hospital Pharmacy

    Silver Spring, Maryland, 20910

  • Holy Cross Hospital

    Silver Spring, Maryland, 20910

  • Millennium Oncology

    The Woodlands, Texas, 77380

  • John D. Archbold Memorial Hospital

    Thomasville, Georgia, 31792

  • Lewis Hall Singletary Oncology Center At John D. Archbold Memorial Hospital

    Thomasville, Georgia, 31792

  • Toledo Clinic Cancer Center - Toledo

    Toledo, Ohio, 43623

  • Toledo Clinic, Inc.

    Toledo, Ohio, 43623

  • Torrance Memorial Medical Center

    Torrance, California, 90505

  • Texas Oncology-Tyler

    Tyler, Texas, 75702

  • Cancer Center of Kansas

    Wellington, Kansas, 67152

  • Maryland Oncology Hematology, P.A.

    Wheaton, Maryland, 20902

  • The Oncology Institute of Hope and Innovation

    Whittier, California, 90602

  • Innovative Clinical Research Institute (ICRI)

    Whittier, California, 90603

  • Cancer Center of Kansas

    Wichita, Kansas, 67208

  • Cancer Center of Kansas

    Wichita, Kansas, 67214

  • Cancer Center Of Kansas

    Winfield, Kansas, 67156

  • Yakima Valley Memorial Hospital/North Star Lodge Cancer Center

    Yakima, Washington, 98902

Other trials in United States

Brazil31 sites

  • Centro de Imagens da Faculdade de Medicina - INCT Medicina Nuclear - PET/CT

    Belo Horizonte, Minas Gerais, 30130-100

  • Hospital das Clinicas Universidade Federal de Minas Gerais

    Belo Horizonte, Minas Gerais, 30130-100

  • Unidade Funcional Apoio Diagnostico e terapeutica por Imagem do HC/UFMG - CT Scan

    Belo Horizonte, Minas Gerais, 30130-100

  • CEMEDI

    Campinas, São Paulo, 13075-460

  • Instituto Radium

    Campinas, São Paulo, 13075-460

  • CAEP - Centro Avancado de Estudos e Pesquisas LTDA

    Campinas, São Paulo, 13087-567

  • Hospital e Maternidade Madre Theodora LTDA

    Campinas, São Paulo, 13087-567

  • CENNI Oncologia

    Campinas, São Paulo, 13092-132

  • Clinica Multimagem

    Goiânia, Goiás, 74175-150

  • Hospital das Clinicas da Universidade Federal de Goias \ Centro de Pesquisa Clinica

    Goiânia, Goiás, 74605-020

  • Fundacao Amaral Carvalho / Fundacao Dr. Amaral Carvalho

    Jaú, São Paulo, 17210-080

  • Fundacao Amaral Carvalho / Fundacao Dr. Amaral Carvalho

    Jaú, São Paulo, 17210-120

  • Unidade de Quimioterapia

    Jaú, São Paulo, 17210-120

  • Central de Misturas Intravenosas do Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Hospital de Clinicas de Porto Alegre - Centro de Pesquisa Clinica

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Servico de Radiologia do Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903

  • CDI - Centro de Diagnostico por Imagem do Hospital Sao Lucas da PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

  • InsCer - Instituto do Cerebro do Rio Grande do Sul - PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Uniao Brasileira de Educacao e Assistencia (UBEA) - Hospital Sao Lucas da PUCRS -

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Hospital Santa Izabel - Setor de Bioimagem

    Salvador, Estado de Bahia, 40050-410

  • Hospital Santa Izabel / Santa Casa de Misericordia da Bahia

    Salvador, Estado de Bahia, 40050-410

  • Casa da Esperanca

    Santo André, São Paulo, 09030-340

  • Fundacao do ABC - FMABC/ Faculdade de Medicina ABC ( CEPHO - Centro de Estudos e Pesquisas de

    Santo André, São Paulo, 09060-650

  • Tecnolab

    São Bernardo do Campo, São Paulo, 09750-670

  • IEP São Lucas (Pharmacy)

    São Paulo, São Paulo, 01242-020

  • Hospital Bandeirantes

    São Paulo, São Paulo, 01506-000

  • Hospital das Clinicas da Faculdade de Medicina da USP / Fundacao Faculdade de Medicina MEC MPAS

    São Paulo, São Paulo, 05403-000

  • Casa de Saude Santa Marcelina (Centro de Pesquisa Santa Marcelina)

    São Paulo, São Paulo, 08270-070

  • IEP Sao Lucas - Instituto de Ensino e Pesquisa Sao Lucas / HEMOMED - Instituto de Oncologia e

    São Paulo, 01236-030

  • Fleury

    São Paulo, 01333-910

Other trials in Brazil

Russia31 sites

  • "State Budget Healthcare Institution ""Chelyabinsk Regional Clinical Center of Oncology

    Chelyabinsk, 454087

  • Federal State-Financed Institution 'North-Caucasian Research and Clinical Center'

    Lermontov, Stavropol Kray, 357340

  • FSBSI 'N.N.Blokhin Russian Cancer Research Center' of MoH of RF

    Moscow, 115478

  • Russian Cancer Research Centre them N.N. Blokhin

    Moscow, 115478

  • LLC "VitaMed"

    Moscow, 121309

  • SBHI of Moscow City Clinical Hospital n.a. S.P.Botkin of Healthcare Department of Moscow

    Moscow, 125284

  • Ramsay Diagnostics

    Moscow, 127473

  • "SBHI of NNR ""Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko"""

    Nizhny Novgorod, Nizhniy Novgorod Region, 603126

  • LLC MC "MRT-Diagnostika"

    Nizhny Novgorod, Nizhniy Novgorod Region, 603126

  • A.Tsyb Medical Radiological Research Centre -

    Obninsk, Kaluga Oblast, 249036

  • FSBI "Russian Research Centre of Radiology and Surgical Technologies" of MoH of RF

    Pesochniy Town, Sankt-Peterburg, 197758

  • Private medical institution "Euromedservice"

    Pushkin, Sankt-Peterburg, 196603

  • SBHI of Stavropol Region "Pyatigorsk Interdistrict Oncology Dispensary

    Pyatigorsk, Stavropol Kray, 357502

  • FSBI "Russian Research Centre of Radiology and Surgical Technologies" of MoH of RF

    Saint Petersburg, Pesochniy TOWN, 197758

  • FSBI "Russian Research Centre of Radiology and Surgical Technologies"

    Saint Petersburg, Pesochniy TOWN, 197758

  • FSBI "Russian Research Centre of Radiology and Surgical Technologies

    Saint Petersburg, Pesochniy TOWN, 197758

  • FSBI 'Russian Research Centre of Radiology and Surgical Technologies

    Saint Petersburg, Pesochniy TOWN, 197758

  • FSBI "Russian Research Centre of Radiology and Surgical Technologies n.a. A.M. Granov" of MoH of RF

    Saint Petersburg, Pesochniy, 197758

  • FSBI "Russian Research Centre of Radiology and Surgical Technologies named after academician

    Saint Petersburg, Pesochniy, 197758

  • FSBI "Russian Research Centre of Radiology and Surgical Technologies

    Saint Petersburg, Pesochniy, 197758

  • FSBI 'National Medical Oncology Research Centre n.a. N.N.Petrov'

    Saint Petersburg, Pos.pesochny, 197758

  • Dr. Berezin Medical Institute

    Saint Petersburg, 194214

  • State Budgetary Institution of Healthcare "Leningrad Regional Clinical Hospital"

    Saint Petersburg, 194291

  • N.P. Bechtereva Institute of Human Brain of the Russian Academy of Sciences

    Saint Petersburg, 197376

  • N.P. Bechtereva Institute of the Human Brain of the Russian Academy of Sciences

    Saint Petersburg, 197376

  • Non-state healthcare institution "Road Clinical Hospital of Joint Stock Company "Russian Railways"

    Saint-Petersurg, 195271

  • State Healthcare Institution Republican Oncology Dispensary

    Saransk, Mordovian Republic, 430032

  • Branch office of LLC 'PET-Technology' at Ufa city

    Ufa, Republic Bashkortostan, 450054

  • State Budgetary Healthcare Institution "Republican Clinical Oncology Dispensary of the Ministry

    Ufa, Republic Bashkortostan, 450054

  • Yaroslavl State Medical Academy

    Yaroslavl, 150010

  • GBUZ of Yaroslavl Region "Regional Clinical Hospital"

    Yaroslavl, 150062

Other trials in Russia

Japan29 sites

  • Akita University Hospital

    Akita, Akita, 010-8543

  • Chiba Cancer Center

    Chiba, Chiba, 260-8717

  • National Hospital Organization Kyushu Medical Center

    Fukuoka, Fukuoka, 810-8563

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, Fukuoka, 811-1395

  • Fukuoka Wajiro PET Diagnostic Imaging Clinic

    Fukuoka, 811-0213

  • National Hospital Organization Kanazawa Medical Center

    Kanazawa, Ishikawa-ken, 920-8650

  • Kanazawa Advanced Medical Center

    Kanazawa, Ishikawa-ken, 9200934

  • National Hospital Organization Osaka Minami Medical Center

    Kawachi-Nagano, Osaka, 586-8521

  • Kobe City Medical Center General Hospital

    Kobe, Hyōgo, 650-0047

  • National Hospital Organization Kumamoto Medical Center

    Kumamoto, Kumamoto, 860-0008

  • Uozumi Clinic

    Kumamoto, Kumamoto, 862-0941

  • Aizawa Hospital

    Matsumoto-shi, Nagano, 390-8510

  • National Hospital Organization Tokyo Medical Center

    Meguro-Ku, Tokyo, 152-8902

  • Nagano Red Cross Hospital

    Nagano, Nagano, 380-8582

  • National Hospital Organization Matsumoto Medical Center

    Nagano, 399-8701

  • East Nagoya Imaging Diagnosis Center

    Nagoya, Aichi-ken, 464-0044

  • Nagoya Daini Red Cross Hospital

    Nagoya, Aichi-ken, 466-8650

  • Hanwa Dai 2 Senboku Hospital

    Naka-ku Sakai, Osaka, 599-8271

  • Kochi Medical School Hospital

    Okocho, Nankoku, Kochi, 783-8505

  • National Hospital Organization Nagasaki Medical Center

    Ōmura, Nagasaki, 856-8562

  • Osaka City University Hospital

    Osaka, Osaka, 545-8586

  • Sendai Kousei Hospital

    Sendai, Miyagi, 980-0873

  • National Hospital Organization Sendai Medical Center

    Sendai, Miyagi, 983-8520

  • Showa University Hospital

    Shinagawa-ku, Tokyo, 142-8666

  • National Hospital Organization Disaster Medical Center

    Tachikawa, Tokyo, 190-0014

  • Tokushima University Hospital

    Tokushima, Tokushima, 770-8503

  • Musashimurayama Hospital

    Tokyo, 2080022

  • Yamagata University Hospital

    Yamagata, Yamagata, 990-9585

  • Showa University Northern Yokohama Hospital

    Yokohama, Kanagawa, 224-8503

Other trials in Japan

Germany24 sites

  • Charite - Universitaetsmedizin Berlin

    Berlin, 12200

  • Charite - Universitatsmedizin Berlin - Campus Benjamin Franklin

    Berlin, 12200

  • Charite - Universitaetsmedizin Berlin, Campus Virchow-Klinikum

    Berlin, 13353

  • Charite - Universitatsmedizin Berlin, Campus Virchow-Klinikum

    Berlin, 13353

  • Charite - Universitatsmedizin Berlin

    Berlin, 13353

  • Klinikum Chemnitz gGmbH - Institut fuer Interventionelle Radiologie und Neuroradiologie

    Chemnitz, 09113

  • Klinikum Chemnitz gGmbH

    Chemnitz, 09113

  • Klinikum Chemnitz gGmbH - Klinik fuer Nuklearmedizin

    Chemnitz, 09116

  • Klinikum Chemnitz gGmbH - Zentralapotheke

    Chemnitz, 09116

  • Praxis im Koeln Triangle

    Cologne, 50679

  • Universitaetsklinikum Essen (AoeR)

    Essen, 45147

  • Universitatsklinikum Essen (AoR)

    Essen, 45147

  • DokuSan Gesellschaft fuer Medizinische Studien mbH & Co. KG

    Herne, 44623

  • Apotheke des St. Anna Hospital

    Herne, 44649

  • EVK Eickel

    Herne, 44651

  • Gemeinschaftspraxis fuer Diagnostische Radiologie und Nuklearmedizin

    Mutlangen, 73557

  • Kliniken Ostalb, Stauferklinikum Schwaebisch Gmuend, Zentrum fuer Innere Medizin

    Mutlangen, 73557

  • Stauferklinikum Schwaebisch Gmuend, Apotheke

    Mutlangen, 73557

  • Universitaetsmedizin Rostock

    Rostock, 18057

  • Klinikum Stuttgart, Klinik fuer Nuklearmedizin

    Stuttgart, 70174

  • Vinzenz von Paul Kliniken gGmbH

    Stuttgart, 70199

  • Radiologie Rhein-Sieg

    Troisdorf, 53840

  • Ueberoertliche Berufsausuebungsgemeinschaft Drs. med. Helmut Forstbauer

    Troisdorf, 53840

  • Zentralapotheke

    Troisdorf, 53842

Other trials in Germany

Spain23 sites

  • Complejo Hospitalario Universitario A Coruna

    A Coruña, 15006

  • Hospital Modelo

    A Coruña, 15011

  • Hospital Universitario Sanitas La Zarzuela

    Aravaca, Madrid, 28023

  • Hospital Del Mar

    Barcelona, 08003

  • Hospital Quiron de Barcelona, IEC

    Barcelona, 08012

  • CETIR, Centre Medic

    Barcelona, 08029

  • Radiodiagnostic CETIR - Clinica del Pilar

    Barcelona, 08029

  • Hospital Universitario Puerta del Mar

    Cadiz, 11009

  • Onkologikoa

    Donostia / San Sebastian, Guipuzcoa, 20014

  • Hospital Clinico Universitario Virgen de la Arrixaca

    El Palmar, Murcia, 30120

  • Hospital Clínico Universitario Virgen de la Arrixaca

    El Palmar, Murcia, 30120

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

  • Hospital Universitario Sanitas La Moraleja

    Madrid, 28050

  • Centro CIMES

    Málaga, 29010

  • Hospital universitario Virgen de la Victoria

    Málaga, 29010

  • Centro Mario Gallegos

    Málaga, 29016

  • Hospital Rey Juan Carlos

    Móstoles, Madrid, 28933

  • Complejo Hospitalario de Ourense. Hematología

    Ourense, 32005

  • Hospital Parc Tauli

    Sabadell, Barcelona, 08208

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital do Meixoeiro Complejo Hospitalario Universitario de Vigo

    Vigo, Pontevedra, 36200

  • H. Quiron Zaragoza

    Zaragoza, 50006

  • Hospital de Dia Quiron Zaragoza

    Zaragoza, 50012

Other trials in Spain

India19 sites

  • HealthCare Global Enterprises Limited

    Bangalore, Karnataka, 560027

  • Apollo Speciality Hospital

    Chennai, Tamil Nadu, 600035

  • Department of Radiology

    Chennai, Tamil Nadu, 600035

  • Global Hospitals

    Hyderabad, Telangana, 500 004

  • Vijaya Diagnostic Centre

    Hyderabad, Telangana, 500029

  • R.K. Birla Cancer Center, Sawai Man Singh Hospital

    Jaipur, Rajasthan, 302004

  • N.R.S Medical College and Hospital

    Kolkata, West Bengal, 700014

  • Spandan PET-CT Unit

    Kolkata, West Bengal, 700014

  • Mangalore Institute of Oncology

    Mangalore, Karnataka, 575002

  • Kasturba Medical College and Hospital

    Manipal, Karnataka, 576104

  • Curie Manavata Cancer Centre

    Nashik, Maharashtra, 422004

  • Department of Radiology, Curie Manavata Cancer Centre

    Nashik, Maharashtra, 422004

  • Rajiv Gandhi Cancer Institute & Research Center (RGCIRC)

    New Delhi, 110 085

  • Department of Radiology

    Pune, Maharashtra, 411001

  • Jehangir Clinical Development Centre Pvt. Ltd.

    Pune, Maharashtra, 411001

  • Ruby Hall clinic

    Pune, Maharashtra, 411001

  • Super Scan Imaging Centre

    Surat, Gujarat, 395001

  • Pathology Department, Unique Hospital Multispeciality & Research Institute

    Surat, Gujarat, 395002

  • Zircon- BIC Imaging Centre

    Surat, Gujarat, 395002

Other trials in India

Italy18 sites

  • U.O. di Ematologia e CTMO - Istituti Ospedalieri di Cremona

    Cremona, CR, 26100

  • U.O. Ematologia 1 - IRCCS AOU San Martino-IST

    Genova, GE, 16132

  • IRCSS A.O.U. San Martino - IST - UO Clinica Ematologica

    Genova, 16132

  • Unità semplice di Medicina Nucleare

    Latina, NAP, 04100

  • IRST - IRCCS U. O. Oncologia Medica

    Meldola, FC, 47014

  • Istituto Europeo di Oncologia

    Milan, MI, 20141

  • SC Ematologia, Fondazione IRCCS Ist Nazionale dei Tumori

    Milan, 20133

  • Unita di Ricerca Clinica

    Monza, MB, 20900

  • Padiglione 1, Torre delle medicine, 6 piano

    Parma, 43100

  • Ematologia e Centro Trapianti - AZ Osp. Ospedali Riuniti Marche Nord (AORMN) - Presidio S. Salvatore

    Pesaro, 61122

  • U.O. Ematologia Universitaria - Dip. Di Oncologia dei Trapianti - AOU Pisana

    Pisa, 56126

  • Medicina nucleare

    Reggio Emilia, Reggio, 42123

  • Radiologia

    Reggio Emilia, Reggio, 42123

  • SC Ematologia - SC Ematologia - Arcispedale Santa Maria Nuova - IRCCS

    Reggio Emilia, Reggio, 42123

  • Policlinico Universitario Campus Bio- Medico-U.O.C. di Ematologia Trapianto Cellule Staminali

    Roma, 00128

  • "Dipartimento di Biotecnologie Cellulari ed Ematologia, Universita ""Sapienza""

    Rome, ROME RM, 00161

  • Az Ospedaliera Santa Maria

    Terni, PG, 05100

  • Clinica Ematologica - A.O.U. Ospedali Riuniti di Ancona

    Torrette Ancona, Palermo, 60121

Other trials in Italy

Turkey (Türkiye)17 sites

  • Hacettepe Universitesi Tip Fakultesi Onkoloji Hastanesi

    Ankara, 06100

  • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Eg. ve Aras.

    Ankara, 06200

  • Ultramar Tibbi Gorunteleme Merkezi

    Ankara, 06420

  • Ultramar Tibbi Goruntuleme Merkezi

    Ankara, 06420

  • Integra Gurses Teshis Tedavi ve Saglik Hizmetleri A.S.

    Ankara, 06540

  • Adnan Menderes University Medical Faculty

    Aydin, 09010

  • Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi

    Gaziantep, 27310

  • Gaziantep Universitesi Sahinbey Arastirma ve Uygulama

    Gaziantep, 27310

  • Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi

    Istanbul, 34093

  • Ege Universitesi Tip Fakultesi Ic Hastaliklari Anabilim Dali

    Izmir, 35040

  • EGE-RAD Bilgisayarli Tomografi Ozel Saglik Hizmetleri ve Malzemeleri Tic.Ltd.Sti.

    Izmir, 35040

  • Erciyes Universitesi Tip Fakultesi Nukleer Tip Laboratuvari

    Kayseri, 38100

  • Erciyes Universitesi Tip Fakultesi Radyoloji Laboratuvari

    Kayseri, 38100

  • Erciyes Universitesi Tip Fakultesi

    Kayseri, 38100

  • Inonu Universitesi Tip Fakultesi Turgut Ozal Tip Merkezi

    Malatya, 44280

  • Celal Bayar University Medical Faculty

    Manisa, 45000

  • Ondokuz Mayis Universitesi Tip Fakultesi

    Samsun, 55139

Other trials in Turkey (Türkiye)

Mexico13 sites

  • Vely Grupo Medico Quirurgico, S.A. de C.V.

    Cuautitlan Izacalli, State of Mexico, 54750

  • Phylasis Clinicas Research S. de R.L. de C.V.

    Cuautitlán Izcalli, State of Mexico, 54769

  • Grupo Medico Camino S.C.

    Mexico City, Mexico City, 03310

  • Imagenus

    Mexico City, Mexico City, 03340

  • Isos Pharmacorp, S.A. de C.V.

    Mexico City, Mexico City, 06700

  • Centro Universitario de Imagen Diagnostica, Radiologia e Imagen del Hospital Universitario

    Monterrey, Nuevo León, 64460

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

    Monterrey, Nuevo León, 64460

  • Cirurgia y Ginecobstetricia de Oaxaca, S.A de C.V.

    Oaxaca City, 68000

  • Oaxaca Site Management Organization S.C.

    Oaxaca City, 68000

  • Hospital Angeles Puebla

    Puebla City, 72190

  • Cancerologia de Queretaro S.C.

    Querétaro, 76090

  • Hospital Infantil Teleton de Oncologia

    Querétaro, 76140

  • Hospital San Jose Norte

    Querétaro, 76158

Other trials in Mexico

Greece12 sites

  • Gen. Hosp. of Athens "Evangelismos - Eye Hosp.- Polikliniki"

    Athens, 10676

  • Gen. Hosp. of Athens "Evangelismos-Eye Hosp. - Polikliniki"

    Athens, 10676

  • Gen. Hosp. of Athens "Evangelismos-Eye Hosp.-Polikliniki"

    Athens, 10676

  • Gen.Hosp.of Athens "Evangelismos-Eye Hosp.-polikiliniki"

    Athens, 10676

  • General Hospital of Athens "Evangelismos - Eye Hosp. - Polikliniki"

    Athens, 10676

  • Bioiatriki S.A.

    Athens, 11526

  • Bioiatriki

    Athens, 11526

  • General Hospital of Athens 'Laiko'

    Athens, 11527

  • """ATTIKON"" Gen. Univ. Hosp"

    Athens, 12462

  • "ATTIKON'' Gen. Univ. Hosp.

    Chaidari, Athens, 12462

  • Magnitiki Patron

    Pátrai, 26222

  • University General Hospital of Patras

    Pátrai, 26504

Other trials in Greece

Romania11 sites

  • Policlinica de Diagnostic Rapid, Hematologie

    Brasov, 500152

  • Policlinica de Diagnostic Rapid SA

    Brasov, 500366

  • Spitalul Clinic Colentina

    Bucharest, 020125

  • Hiperdia Ritmului

    Bucharest, 021675

  • Affidea Fundeni

    Bucharest, 022328

  • Affidea Romania SRL

    Bucharest, 022328

  • Spitalul Clinic Coltea, Clinica de Hematologie

    Bucharest, 030171

  • Institutul Oncologic Prof. Dr. Ion Chiricuta, Laborator Radiologie si Imagistica Medicala

    Cluj-Napoca, 400015

  • Institutul Oncologic Prof. Dr. Ion Chiricuta, Sectia Oncologie Medicala

    Cluj-Napoca, 400015

  • Clinica de Hematologie-Institutul Oncologic, Prof. Dr. Ion Chiricuta

    Cluj-Napoca, 400124

  • CT Clinic S.R.L.

    Cluj-Napoca, 400489

Other trials in Romania

Ukraine11 sites

  • "Municipal Institution ""Chernivtsi Regional Clinical Oncology Center"",

    Chernivtsi, 58013

  • MI 'City Dnipropetrovsk Multi-field Clin. Hospital #4 of DRC',

    Dnipropetrovsk, 49102

  • Municipal Non-Profit Enterprise "Regional Oncology Centre"

    Kharkiv, 61070

  • National Cancer Institute

    Kyiv, 03022

  • "MedX-Ray International Group" LLC

    Obukhiv, Kyiv Oblast, 08720

  • "Mediks-rey International Group" LLC

    Obukhiv District, Kyiv Oblast, 08720

  • "MedX-rey International Group" LLC

    Obukhiv District, Kyiv Oblast, 08720

  • "Central City Clinical Hospital, City Oncology Center, SHEI ""Uzhhorod National University"", Chair

    Uzhhorod, 88017

  • Podilskyy Regional Oncology Center, Chemotherapy Department

    Vinnytsia, 21029

  • Municipal Establishment 'Zaporizhzhia Regional Clinical Oncology Dispensary'

    Zaporizhzhya, 69040

  • LLC "Diaservis"

    Zaporizhzhya, 69076

Other trials in Ukraine

Belgium10 sites

  • Hopital Erasme

    Brussels, 1070

  • Nuclear Medicine Department

    Brussels, 1200

  • Grand Hopital de Charleroi-Site Notre-Dame

    Charleroi, 6000

  • PET/CT facility: Grand Hopital de Charleroi (GHdC) - site Notre-Dame

    Charleroi, 6000

  • Pharmacy Department: Grand Hopital de Charleroi (GHdC) - site Notre-Dame

    Charleroi, 6000

  • Pharmacy Department, Centre Hospitalier De Jolimont - Lobbes

    La Louviere (Haine-Saint Paul), 7100

  • Centre Hospitalier de Jolimont - Lobbes

    La Louviere (Haine-Saint-Paul), 7100

  • Radiology Department

    La Louviere (Haine-Saint-Paul), 7100

  • C.H.U. Ambroise Pare

    Mons, 7000

  • Pharmacy Department, CHU Ambroise Pare

    Mons, 7000

Other trials in Belgium

France9 sites

  • Hopital Duchenne Chu - Boulogne Sur Mer

    Boulogne-sur-Mer, NAP, 62321

  • Hopital Duchenne Chu - Boulogne Sur Mer

    Boulogne-sur-Mer, 62321

  • Centre Hospitalier De Bourg En Bresse

    Bourg-en-Bresse, 01012

  • Hopital Morvan-CHU Brest- Service Hematologie Clinique

    Brest, 29609

  • Centre Hospitalier Universitaire Cote de Nacre

    Caen, 14033

  • Centre Hospitalier du Mans

    Le Mans, 72037

  • Clinique de la Sauvegarde

    Lyon, 69009

  • CHU Marseille Hopital de La Conception

    Marseille, Marseille Cedex 05, 13385

  • CH de Mulhouse, Hopital Emile Muller

    Mulhouse, Mulhouse Cedex, 68100

Other trials in France

Portugal8 sites

  • Hospital de Braga

    Braga, 4710-243

  • Hospital CUF Descobertas

    Lisbon, 1998-018

  • Unidade Local de Saude de Matosinhos E.P.E. - Hospital Pedro Hispano S.A.

    Matosinhos Municipality, Porto District, 4464-513

  • CIMC

    Porto, 4050-075

  • Dr. Campos Costa Clinic

    Porto, 4050-075

  • Centro Hospitalar do Porto-Hospital de Santo Antonio E.P.E.

    Porto, 4099 - 001

  • Instituto Portugues de Oncologia do Porto Francisco Gentil E.P.E

    Porto, 4200-072

  • Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.

    Vila Nova de Gaia, 4434-502

Other trials in Portugal

South Africa8 sites

  • NIKSCH & PARTNERS t/a CAPITAL RADIOLOGY

    Groenkloof, Gauteng, 0181

  • The Medical Oncology Centre of Rosebank

    Johannesburg, Gauteng, 2196

  • Department of Medical Oncology, University of Pretoria, Steve Biko Academic Hospitals Complex

    Pretoria, Gauteng, 0002

  • Albert Alberts Stem Cell Transplant Centre

    Pretoria, Gauteng, 0044

  • Dr JN De Jong and Partners t/a East Rad

    Pretoria, Gauteng, 0044

  • NIKSCH & PARTNERS t/a CAPITAL RADIOLOGY

    Pretoria, Gauteng, 0181

  • Drs Sulman & Partners Specialist Radiologists

    Rosebank, Gauteng, 2196

  • Drs Bloch & Partners Incorporated

    Sandton, Gauteng, 2191

Other trials in South Africa

South Korea7 sites

  • Hallym University Sacred Heart Hospital

    Anyang-si, Gyeonggi-do, 14068

  • Inje University Busan Paik Hospital

    Busan, 47392

  • Chonbuk National University Hospital

    Jeonju, Jeollabuk-do, 54907

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 463-707

  • Seoul National University Hospital

    Seoul, 03080

  • Samsung Medical Center

    Seoul, 06351

  • Ulsan University Hospital

    Ulsan, Korea, 44033

Other trials in South Korea

United Kingdom7 sites

  • Royal United Hospitals Bath NHS Foundation Trust

    Bath, BA1 3NG

  • Cobalt Diagnostic Imaging

    Cheltenham, Glos., GL53 7AS

  • Barts Health NHS Trust

    London, EC1A 7BE

  • Positron Emission Tomography (PET) Centre

    Newcastle upon Tyne, NE4 6BE

  • City Hospitals Sunderland NHS Foundation Trust-Sunderland Royal Hospital

    Sunderland, SR4 7TP

  • Diagnostic Imaging

    Sunderland, SR4 7TP

  • Southend University Hospital NHS Foundation Trust

    Westcliff-on-Sea, Essex, SS0 0RY

Other trials in United Kingdom

Poland6 sites

  • Klinika Nowotworow Ukladu Chlonnego Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie

    Warsaw, 02-781

  • Euromedic Wroclawskie Centrum Medyczne II

    Wroclaw, 50-420

  • Euromedic Wroclawskie Centrum Medyczne III

    Wroclaw, 50-557

  • Dolnoslaskie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku

    Wroclaw, 53-439

  • Euromedic Wroclawskie Centrum Medyczne I

    Wroclaw, 53-439

  • Apteka Dolnoslaskiego Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku

    Wroclaw, 54-424

Other trials in Poland

Switzerland6 sites

  • Universitatsspital Basel

    Basel, 4031

  • Inselspital Bern

    Bern, 3010

  • Apotheke, Spital STS AG

    Thun, 3600

  • Onkologiezentrum Thun-Berner Oberland Spital Sts Ag

    Thun, 3600

  • Kantonsapotheke Zuerich

    Zurich, 8006

  • UniversitaetsSpital Zuerich

    Zurich, 8091

Other trials in Switzerland

Belarus5 sites

  • Healthcare Institution "Brest Regional Oncologic Dispensary"

    Brest, 224027

  • SI 'Republican Research and Practice Centre of Oncology and Medical Radiology n.a. N.N. Alexandrov'

    Lyasny, Minsk Oblast, 220013

  • SI 'Republican Research and Practice Centre of Oncology and Medical Radiology n.a. N.N. Alexandrov'

    Lyasny, Minsk Oblast, 223040

  • Healthcare Institution 'Minsk City Clinical Oncology Dispensary'

    Minsk, 220013

  • SI Republican Research and Practice Centre of oncology and medical radiology n.a N.N Alexandrov

    Republic of Belarus, 223040

Other trials in Belarus

Croatia5 sites

  • University Hospital Center Zagreb, Department of Nuclear Medicine and Radiation Protection

    Zagreb, 10 000

  • University Hospital Center Zagreb, Department of Pathology and Cytology

    Zagreb, 10 000

  • University Hospital Center Zagreb, Department of Radiology

    Zagreb, 10 000

  • University Hospital Centre "Sestre Milosrdnice"

    Zagreb, 10000

  • University Hospital Centre Zagreb

    Zagreb, 10000

Other trials in Croatia

Lebanon5 sites

  • Doctors Center Radiology

    Beirut

  • Mount Lebanon Hospital

    Beirut

  • Middle East Institute Of Health

    El Metn

  • Ain Wazein Hospital

    Mount Lebanon

  • Hammoud Hospital, University Medical Center

    Saida, Southern Governate

Other trials in Lebanon

Austria3 sites

  • Krankenhaus der Barmherzigen Schwestern Linz

    Linz, 4010

  • Kepler Universitaetsklinikum GmbH

    Linz, 4020

  • Kepler Universitaetsklinikum GmbH

    Linz, 4021

Other trials in Austria

Georgia3 sites

  • "LTD ""M. Zodelava's Hematology Centre"""

    Tbilisi, 0112

  • LTD "Research Institute of Clinical Medicine"

    Tbilisi, 0112

  • High Technology Medical Center, University Clinic

    Tbilisi, 0144

Other trials in Georgia

Peru3 sites

  • Pet Scan Peru

    Lima, 18

  • Resocentro

    Lima, 18

  • Instituto Nacional de Enfermedades Neoplasicas

    Surquillo, Lima region, 34

Other trials in Peru

Puerto Rico3 sites

  • Modern Radiology, PSC

    Coto Laurel, PR, 00780

  • Ad-Vance Medical Research, LLC

    Ponce, PR, 00717

  • Caribe MRI and CT

    Ponce, PR, 00717

Other trials in Puerto Rico

Thailand3 sites

  • Cardiology Unit,Department of Medicine, Faculty of Medicine, Ramathibodi Hospital,

    Bangkok, 10400

  • Department of Radiology, Ramathibodi Hospital

    Bangkok, 10400

  • National Cancer Institute

    Bangkok, 10400

Other trials in Thailand

Philippines2 sites

  • University of Philippines Manila-Philippine General Hospital

    Manila, National Capital Region, 1000

  • St. Luke's Medical Center

    Quezon City, 1102

Other trials in Philippines

About this study

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

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.

Being tested
PF-05280586, MabThera®
Keywords
rituximab, follicular lymphoma, Non-Hodgkin lymphoma, Non-Hodgkin's lymphoma
Medical subject headings
Lymphoma, Follicular, Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-05280586Biological

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

  • MabThera®Biological

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

Study groups in NCT02213263
Study groupRoleWhat they receive
PF-05280586ExperimentalNot described
Receives: Biological: PF-05280586
MabThera®Active comparatorNot described
Receives: Biological: MabThera®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 26

Secondary outcomes (15)

  1. 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.

    Measured: Baseline up to Week 52

  2. 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.

    Measured: Baseline up to Week 52

  3. 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.

    Measured: Baseline up to Week 52

  4. 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.

    Measured: Baseline up to Week 52

  5. 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.

    Measured: Baseline up to Week 52

  6. 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.

    Measured: From randomization until disease progression, death or permanent discontinuation from treatment/study due to any reason, or up to Week 52

  7. 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.

    Measured: From randomization until disease progression or death due to any cause or up to Week 52

  8. 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.

    Measured: Week 26

  9. 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.

    Measured: 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

  10. 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.

    Measured: From randomization until death due to any cause or up to Week 52

  11. Maximum Observed Serum Concentration (Cmax) of PF-05280586 and Rituximab-EU

    Measured: 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

  12. Minimum Observed (Trough) Serum Concentration (Ctrough) of PF-05280586 and Rituximab-EU

    Measured: Predose (within 4 hours prior to the start of dosing) on Day 1, 8, 15, and 22

  13. Cluster of Differentiation (CD) 19-Positive B-Cell Counts

    Measured: Baseline, Week 2, 3, 4, 5, 13, 26, 39, 52

  14. 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.

    Measured: Baseline up to Week 52

  15. 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).

    Measured: Baseline up to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2014 (estimated)
  2. Study start30 Sep 2014
  3. Primary completion23 Oct 2017
  4. Study completion19 Apr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
394 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02213263
Sponsor's protocol ID
B3281006
Other IDs
2014-000132-41, REFLECTIONS, 2014
Status last verified
Jun 2019
First submitted
7 Aug 2014
Last updated
20 Jun 2019
Data monitoring committee
Yes
Individual data sharing
Yes: 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.

Publications

  • Courville J, Nastoupil L, Kaila N, Kelton J, Zhang J, Alcasid A, Nava-Parada P. Factors Influencing Infusion-Related Reactions Following Dosing of Reference Rituximab and PF-05280586, a Rituximab Biosimilar. BioDrugs. 2021 Jul;35(4):459-468. doi: 10.1007/s40259-021-00487-6. Epub 2021 Jun 21.

    PubMed 34152584

  • Sharman JP, Liberati AM, Ishizawa K, Khan T, Robbins J, Alcasid A, Rosenberg JA, Aurer I. A Randomized, Double-Blind, Efficacy and Safety Study of PF-05280586 (a Rituximab Biosimilar) Compared with Rituximab Reference Product (MabThera(R)) in Subjects with Previously Untreated CD20-Positive, Low-Tumor-Burden Follicular Lymphoma (LTB-FL). BioDrugs. 2020 Apr;34(2):171-181. doi: 10.1007/s40259-019-00398-7.

    PubMed 31820339

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PF-05280586 and MabThera® in people with Follicular Lymphoma, run by Pfizer at 423 sites in 30 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 423 sites in United States, Brazil, Russia, Japan, Germany and 25 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR): Percentage of Participants With Overall Response (OR) at Week 26 (time frame: Week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02213263, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2019.

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