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
3 other identifiers
interventional
394
29 countries
413
Brief Summary
This study will compare the safety and effectiveness of PF-05280586 versus rituximab-EU in patients with CD20-positive, low tumor burden follicular lymphoma. The primary hypothesis to be tested in this study is that the effectiveness of PF-05280586, as measured by the Overall Response Rate, is similar to that of rituximab-EU.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2014
Typical duration for phase_3
413 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 7, 2014
CompletedFirst Posted
Study publicly available on registry
August 11, 2014
CompletedStudy Start
First participant enrolled
September 30, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 23, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 19, 2018
CompletedResults Posted
Study results publicly available
October 30, 2018
CompletedJune 20, 2019
June 1, 2019
3.1 years
August 7, 2014
October 2, 2018
June 18, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Week 26
Secondary Outcomes (15)
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Baseline up to Week 52
Number of Participants With Treatment Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
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
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
Baseline up to Week 52
Number of Participants With Clinically Significant Laboratory Abnormalities
Baseline up to Week 52
- +10 more secondary outcomes
Study Arms (2)
PF-05280586
EXPERIMENTALMabThera®
ACTIVE COMPARATORInterventions
PF-05280586 (rituximab-Pfizer) concentrate for solution for infusion 375mg/m2 administered via IV infusion on Days 1, 8, 15, and 22
MabThera® (rituximab-EU) concentrate for solution for infusion 375mg/m2 administered via IV infusion on Days 1, 8, 15, and 22
Eligibility Criteria
You may qualify if:
- Confirmed diagnosis of low tumor burden, CD20-positive follicular lymphoma
- Ann Arbor Stage II, III, or IV
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (423)
Pacific Cancer Medical Center, Inc.
Anaheim, California, 92801, United States
The Oncology Institute of Hope and Innovation
Anaheim, California, 92801, United States
Compassionate Care Research Group, Inc., at Compassionate Cancer Care Medical Group, Inc.
Corona, California, 92879, United States
The Oncology Institute of Hope and Innovation
Downey, California, 90241, United States
Compassionate Care Research Group, Inc., at Compassionate Cancer Care Medical Group, Inc.
Fountain Valley, California, 92708, United States
Global Cancer Research Institute (GCRI), Inc
Gilroy, California, 95020, United States
Saint Louise Regional Hospital Radiology Department (Radiology Only)
Gilroy, California, 95020, United States
South Valley Imaging Center (Imaging Only)
Gilroy, California, 95020, United States
Los Angeles Hematology Oncology Medical Group
Glendale, California, 91204, United States
The Oncology Institute of Hope and Innovation
Glendale, California, 91204, United States
Los Angeles Hematology Oncology Medical Group
Glendale, California, 91206, United States
The Oncology Institute of Hope and Innovation
Long Beach, California, 90805, United States
Los Angeles Hematology Oncology Medical Group
Los Angeles, California, 90017, United States
Los Angeles Hematology Oncology Medical Group
Los Angeles, California, 90057, United States
The Oncology Institute of Hope and Innovation
Lynwood, California, 90262, United States
The Oncology Institute of Hope and Innovation
Montebello, California, 90640, United States
Comprehensive Cancer Center at Desert Regional Medical Center
Palm Springs, California, 92262, United States
Torrance Health Association DBA, Torrance Memorial Physician, Network/Cancer Care Associates
Redondo Beach, California, 90277, United States
Compassionate Care Research Group, Inc., at Compassionate Cancer Care Medical Group, Inc.
Riverside, California, 92501, United States
Global Cancer Research Institute, Inc.
San Jose, California, 95124, United States
O'Connor Hospital
San Jose, California, 95128, United States
PET Imaging of San Jose (Imaging Only)
San Jose, California, 95128, United States
The Oncology Institute of Hope and Innovation
Santa Ana, California, 92705, United States
Torrance Memorial Medical Center
Torrance, California, 90505, United States
The Oncology Institute of Hope and Innovation
Whittier, California, 90602, United States
Innovative Clinical Research Institute (ICRI)
Whittier, California, 90603, United States
Rocky Mountain Cancer Centers
Aurora, Colorado, 80012, United States
Rocky Mountain Cancer Centers
Boulder, Colorado, 80303, United States
Rocky Mountain Cancer Centers
Denver, Colorado, 80218, United States
Rocky Mountain Cancer Center-Lakewood (Laboratory)
Lakewood, Colorado, 80228, United States
Rocky Mountain Cancer Centers (RMCC) - Lakewood - St Anthony
Lakewood, Colorado, 80228, United States
Rocky Mountain Cancer Centers
Lone Tree, Colorado, 80124, United States
Rocky Mountain Cancer Center Pueblo
Pueblo, Colorado, 81008, United States
John D. Archbold Memorial Hospital
Thomasville, Georgia, 31792, United States
Lewis Hall Singletary Oncology Center At John D. Archbold Memorial Hospital
Thomasville, Georgia, 31792, United States
Northwestern Medicine West Region
DeKalb, Illinois, 60115, United States
Cancer Center,Northwestern Medicine, West Region
Geneva, Illinois, 60134, United States
Cancer Center of Kansas
Chanute, Kansas, 66720, United States
Cancer Center of Kansas
Dodge City, Kansas, 67801, United States
Cancer Center of Kansas
El Dorado, Kansas, 67042, United States
Cancer Center of Kansas
Independence, Kansas, 67301, United States
Cancer Center of Kansas
Kingman, Kansas, 67068, United States
Cancer Center of Kansas
Liberal, Kansas, 67905, United States
Cancer Center of Kansas
McPherson, Kansas, 67460, United States
Cancer Center of Kansas
Newton, Kansas, 67114, United States
The University of Kansas Cancer Center
Overland Park, Kansas, 66210, United States
Cancer Center of Kansas
Parsons, Kansas, 67357, United States
Cancer Center of Kansas
Salina, Kansas, 67401, United States
Cancer Center of Kansas
Wellington, Kansas, 67152, United States
Cancer Center of Kansas
Wichita, Kansas, 67208, United States
Cancer Center of Kansas
Wichita, Kansas, 67214, United States
Cancer Center Of Kansas
Winfield, Kansas, 67156, United States
PET/CT facility Seton Imaging Center
Baltimore, Maryland, 21229, United States
Saint Agnes Hospital
Baltimore, Maryland, 21229, United States
Rcca Md Llc
Bethesda, Maryland, 20817, United States
Holy Cross Hospital Resource Center
Silver Spring, Maryland, 20902, United States
Holy Cross Hospital Hospital Pharmacy
Silver Spring, Maryland, 20910, United States
Holy Cross Hospital
Silver Spring, Maryland, 20910, United States
Maryland Oncology Hematology, P.A.
Wheaton, Maryland, 20902, United States
The University of Kansas Cancer Center
Kansas City, Missouri, 64131, United States
The University of Kansas Cancer Center
Kansas City, Missouri, 64154, United States
The University of Kansas Cancer Center
Lee's Summit, Missouri, 64064, United States
Saint Francis Medical Center, Saint Francis Cancer Treatment Center
Grand Island, Nebraska, 68803, United States
Saint Francis Medical Center
Grand Island, Nebraska, 68803, United States
Saint Francis Medical Center, Saint Francis Cancer Treatment Center
Hastings, Nebraska, 68901, United States
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, 89052, United States
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, 89074, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89128, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89148, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169, United States
Brody School of Medicine at East Carolina University
Greenville, North Carolina, 27834, United States
Vidant Medical Center Pharmacy
Greenville, North Carolina, 27834, United States
Vidant Medical Center
Greenville, North Carolina, 27834, United States
Toledo Clinic Cancer Center - Maumee
Maumee, Ohio, 43537, United States
Toledo Clinic Cancer Center - Toledo
Toledo, Ohio, 43623, United States
Toledo Clinic, Inc.
Toledo, Ohio, 43623, United States
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, 97401, United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920, United States
San Antonio Military Medical Center- Department of Pharmacy
Fort Sam Houston, Texas, 78234, United States
San Antonio Military Medical Center- Department of Radiology
Fort Sam Houston, Texas, 78234, United States
San Antonio Military Medical Center
Fort Sam Houston, Texas, 78234, United States
Investigational Products Center (I PC)
Fort Worth, Texas, 76177, United States
Investigational Products Center (IPC)
Fort Worth, Texas, 76177, United States
Millennium Oncology
Houston, Texas, 77090, United States
US Oncology Investigational Products Center (IPC)
Irving, Texas, 75063, United States
Millennium Oncology
Kingwood, Texas, 77339, United States
Texas Oncology - Longview Cancer Center
Longview, Texas, 75601, United States
Millennium Oncology
Shenandoah, Texas, 77384, United States
Millennium Oncology
The Woodlands, Texas, 77380, United States
Texas Oncology-Tyler
Tyler, Texas, 75702, United States
Yakima Valley Memorial Hospital/North Star Lodge Cancer Center
Yakima, Washington, 98902, United States
Krankenhaus der Barmherzigen Schwestern Linz
Linz, 4010, Austria
Kepler Universitaetsklinikum GmbH
Linz, 4020, Austria
Kepler Universitaetsklinikum GmbH
Linz, 4021, Austria
SI 'Republican Research and Practice Centre of Oncology and Medical Radiology n.a. N.N. Alexandrov'
Lyasny, Minsk Oblast, 220013, Belarus
SI 'Republican Research and Practice Centre of Oncology and Medical Radiology n.a. N.N. Alexandrov'
Lyasny, Minsk Oblast, 223040, Belarus
Healthcare Institution "Brest Regional Oncologic Dispensary"
Brest, 224027, Belarus
Healthcare Institution 'Minsk City Clinical Oncology Dispensary'
Minsk, 220013, Belarus
SI Republican Research and Practice Centre of oncology and medical radiology n.a N.N Alexandrov
Republic of Belarus, 223040, Belarus
Hopital Erasme
Brussels, 1070, Belgium
Nuclear Medicine Department
Brussels, 1200, Belgium
Grand Hopital de Charleroi-Site Notre-Dame
Charleroi, 6000, Belgium
PET/CT facility: Grand Hopital de Charleroi (GHdC) - site Notre-Dame
Charleroi, 6000, Belgium
Pharmacy Department: Grand Hopital de Charleroi (GHdC) - site Notre-Dame
Charleroi, 6000, Belgium
Pharmacy Department, Centre Hospitalier De Jolimont - Lobbes
La Louviere (Haine-Saint Paul), 7100, Belgium
Centre Hospitalier de Jolimont - Lobbes
La Louviere (Haine-Saint-Paul), 7100, Belgium
Radiology Department
La Louviere (Haine-Saint-Paul), 7100, Belgium
C.H.U. Ambroise Pare
Mons, 7000, Belgium
Pharmacy Department, CHU Ambroise Pare
Mons, 7000, Belgium
Hospital Santa Izabel - Setor de Bioimagem
Salvador, Estado de Bahia, 40050-410, Brazil
Hospital Santa Izabel / Santa Casa de Misericordia da Bahia
Salvador, Estado de Bahia, 40050-410, Brazil
Clinica Multimagem
Goiânia, Goiás, 74175-150, Brazil
Hospital das Clinicas da Universidade Federal de Goias \ Centro de Pesquisa Clinica
Goiânia, Goiás, 74605-020, Brazil
Centro de Imagens da Faculdade de Medicina - INCT Medicina Nuclear - PET/CT
Belo Horizonte, Minas Gerais, 30130-100, Brazil
Hospital das Clinicas Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, 30130-100, Brazil
Unidade Funcional Apoio Diagnostico e terapeutica por Imagem do HC/UFMG - CT Scan
Belo Horizonte, Minas Gerais, 30130-100, Brazil
Central de Misturas Intravenosas do Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Hospital de Clinicas de Porto Alegre - Centro de Pesquisa Clinica
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Servico de Radiologia do Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
CDI - Centro de Diagnostico por Imagem do Hospital Sao Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
InsCer - Instituto do Cerebro do Rio Grande do Sul - PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Uniao Brasileira de Educacao e Assistencia (UBEA) - Hospital Sao Lucas da PUCRS -
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
CEMEDI
Campinas, São Paulo, 13075-460, Brazil
Instituto Radium
Campinas, São Paulo, 13075-460, Brazil
CAEP - Centro Avancado de Estudos e Pesquisas LTDA
Campinas, São Paulo, 13087-567, Brazil
Hospital e Maternidade Madre Theodora LTDA
Campinas, São Paulo, 13087-567, Brazil
CENNI Oncologia
Campinas, São Paulo, 13092-132, Brazil
Fundacao Amaral Carvalho / Fundacao Dr. Amaral Carvalho
Jaú, São Paulo, 17210-080, Brazil
Fundacao Amaral Carvalho / Fundacao Dr. Amaral Carvalho
Jaú, São Paulo, 17210-120, Brazil
Unidade de Quimioterapia
Jaú, São Paulo, 17210-120, Brazil
Casa da Esperanca
Santo André, São Paulo, 09030-340, Brazil
Fundacao do ABC - FMABC/ Faculdade de Medicina ABC ( CEPHO - Centro de Estudos e Pesquisas de
Santo André, São Paulo, 09060-650, Brazil
Tecnolab
São Bernardo do Campo, São Paulo, 09750-670, Brazil
IEP São Lucas (Pharmacy)
São Paulo, São Paulo, 01242-020, Brazil
Hospital Bandeirantes
São Paulo, São Paulo, 01506-000, Brazil
Hospital das Clinicas da Faculdade de Medicina da USP / Fundacao Faculdade de Medicina MEC MPAS
São Paulo, São Paulo, 05403-000, Brazil
Casa de Saude Santa Marcelina (Centro de Pesquisa Santa Marcelina)
São Paulo, São Paulo, 08270-070, Brazil
IEP Sao Lucas - Instituto de Ensino e Pesquisa Sao Lucas / HEMOMED - Instituto de Oncologia e
São Paulo, 01236-030, Brazil
Fleury
São Paulo, 01333-910, Brazil
University Hospital Center Zagreb, Department of Nuclear Medicine and Radiation Protection
Zagreb, 10 000, Croatia
University Hospital Center Zagreb, Department of Pathology and Cytology
Zagreb, 10 000, Croatia
University Hospital Center Zagreb, Department of Radiology
Zagreb, 10 000, Croatia
University Hospital Centre "Sestre Milosrdnice"
Zagreb, 10000, Croatia
University Hospital Centre Zagreb
Zagreb, 10000, Croatia
CHU Marseille Hopital de La Conception
Marseille, Marseille Cedex 05, 13385, France
CH de Mulhouse, Hopital Emile Muller
Mulhouse, Mulhouse Cedex, 68100, France
Hopital Duchenne Chu - Boulogne Sur Mer
Boulogne-sur-Mer, NAP, 62321, France
Hopital Duchenne Chu - Boulogne Sur Mer
Boulogne-sur-Mer, 62321, France
Centre Hospitalier De Bourg En Bresse
Bourg-en-Bresse, 01012, France
Hopital Morvan-CHU Brest- Service Hematologie Clinique
Brest, 29609, France
Centre Hospitalier Universitaire Cote de Nacre
Caen, 14033, France
Centre Hospitalier du Mans
Le Mans, 72037, France
Clinique de la Sauvegarde
Lyon, 69009, France
"LTD ""M. Zodelava's Hematology Centre"""
Tbilisi, 0112, Georgia
LTD "Research Institute of Clinical Medicine"
Tbilisi, 0112, Georgia
High Technology Medical Center, University Clinic
Tbilisi, 0144, Georgia
Charite - Universitaetsmedizin Berlin
Berlin, 12200, Germany
Charite - Universitatsmedizin Berlin - Campus Benjamin Franklin
Berlin, 12200, Germany
Charite - Universitaetsmedizin Berlin, Campus Virchow-Klinikum
Berlin, 13353, Germany
Charite - Universitatsmedizin Berlin, Campus Virchow-Klinikum
Berlin, 13353, Germany
Charite - Universitatsmedizin Berlin
Berlin, 13353, Germany
Klinikum Chemnitz gGmbH - Institut fuer Interventionelle Radiologie und Neuroradiologie
Chemnitz, 09113, Germany
Klinikum Chemnitz gGmbH
Chemnitz, 09113, Germany
Klinikum Chemnitz gGmbH - Klinik fuer Nuklearmedizin
Chemnitz, 09116, Germany
Klinikum Chemnitz gGmbH - Zentralapotheke
Chemnitz, 09116, Germany
Praxis im Koeln Triangle
Cologne, 50679, Germany
Universitaetsklinikum Essen (AoeR)
Essen, 45147, Germany
Universitatsklinikum Essen (AoR)
Essen, 45147, Germany
DokuSan Gesellschaft fuer Medizinische Studien mbH & Co. KG
Herne, 44623, Germany
Apotheke des St. Anna Hospital
Herne, 44649, Germany
EVK Eickel
Herne, 44651, Germany
Gemeinschaftspraxis fuer Diagnostische Radiologie und Nuklearmedizin
Mutlangen, 73557, Germany
Kliniken Ostalb, Stauferklinikum Schwaebisch Gmuend, Zentrum fuer Innere Medizin
Mutlangen, 73557, Germany
Stauferklinikum Schwaebisch Gmuend, Apotheke
Mutlangen, 73557, Germany
Universitaetsmedizin Rostock
Rostock, 18057, Germany
Klinikum Stuttgart, Klinik fuer Nuklearmedizin
Stuttgart, 70174, Germany
Vinzenz von Paul Kliniken gGmbH
Stuttgart, 70199, Germany
Radiologie Rhein-Sieg
Troisdorf, 53840, Germany
Ueberoertliche Berufsausuebungsgemeinschaft Drs. med. Helmut Forstbauer
Troisdorf, 53840, Germany
Zentralapotheke
Troisdorf, 53842, Germany
Gen. Hosp. of Athens "Evangelismos - Eye Hosp.- Polikliniki"
Athens, 10676, Greece
Gen. Hosp. of Athens "Evangelismos-Eye Hosp. - Polikliniki"
Athens, 10676, Greece
Gen. Hosp. of Athens "Evangelismos-Eye Hosp.-Polikliniki"
Athens, 10676, Greece
Gen.Hosp.of Athens "Evangelismos-Eye Hosp.-polikiliniki"
Athens, 10676, Greece
General Hospital of Athens "Evangelismos - Eye Hosp. - Polikliniki"
Athens, 10676, Greece
Bioiatriki S.A.
Athens, 11526, Greece
Bioiatriki
Athens, 11526, Greece
General Hospital of Athens 'Laiko'
Athens, 11527, Greece
"""ATTIKON"" Gen. Univ. Hosp"
Athens, 12462, Greece
"ATTIKON'' Gen. Univ. Hosp.
Chaidari, Athens, 12462, Greece
Magnitiki Patron
Pátrai, 26222, Greece
University General Hospital of Patras
Pátrai, 26504, Greece
Super Scan Imaging Centre
Surat, Gujarat, 395001, India
Pathology Department, Unique Hospital Multispeciality & Research Institute
Surat, Gujarat, 395002, India
Zircon- BIC Imaging Centre
Surat, Gujarat, 395002, India
HealthCare Global Enterprises Limited
Bangalore, Karnataka, 560027, India
Mangalore Institute of Oncology
Mangalore, Karnataka, 575002, India
Kasturba Medical College and Hospital
Manipal, Karnataka, 576104, India
Curie Manavata Cancer Centre
Nashik, Maharashtra, 422004, India
Department of Radiology, Curie Manavata Cancer Centre
Nashik, Maharashtra, 422004, India
Department of Radiology
Pune, Maharashtra, 411001, India
Jehangir Clinical Development Centre Pvt. Ltd.
Pune, Maharashtra, 411001, India
Ruby Hall clinic
Pune, Maharashtra, 411001, India
R.K. Birla Cancer Center, Sawai Man Singh Hospital
Jaipur, Rajasthan, 302004, India
Apollo Speciality Hospital
Chennai, Tamil Nadu, 600035, India
Department of Radiology
Chennai, Tamil Nadu, 600035, India
Global Hospitals
Hyderabad, Telangana, 500 004, India
Vijaya Diagnostic Centre
Hyderabad, Telangana, 500029, India
N.R.S Medical College and Hospital
Kolkata, West Bengal, 700014, India
Spandan PET-CT Unit
Kolkata, West Bengal, 700014, India
Rajiv Gandhi Cancer Institute & Research Center (RGCIRC)
New Delhi, 110 085, India
U.O. di Ematologia e CTMO - Istituti Ospedalieri di Cremona
Cremona, CR, 26100, Italy
IRST - IRCCS U. O. Oncologia Medica
Meldola, FC, 47014, Italy
U.O. Ematologia 1 - IRCCS AOU San Martino-IST
Genova, GE, 16132, Italy
Unita di Ricerca Clinica
Monza, MB, 20900, Italy
Istituto Europeo di Oncologia
Milan, MI, 20141, Italy
Unità semplice di Medicina Nucleare
Latina, NAP, 04100, Italy
Clinica Ematologica - A.O.U. Ospedali Riuniti di Ancona
Torrette Ancona, Palermo, 60121, Italy
Az Ospedaliera Santa Maria
Terni, PG, 05100, Italy
Medicina nucleare
Reggio Emilia, Reggio, 42123, Italy
Radiologia
Reggio Emilia, Reggio, 42123, Italy
SC Ematologia - SC Ematologia - Arcispedale Santa Maria Nuova - IRCCS
Reggio Emilia, Reggio, 42123, Italy
"Dipartimento di Biotecnologie Cellulari ed Ematologia, Universita ""Sapienza""
Rome, ROME RM, 00161, Italy
IRCSS A.O.U. San Martino - IST - UO Clinica Ematologica
Genova, 16132, Italy
SC Ematologia, Fondazione IRCCS Ist Nazionale dei Tumori
Milan, 20133, Italy
Padiglione 1, Torre delle medicine, 6 piano
Parma, 43100, Italy
Ematologia e Centro Trapianti - AZ Osp. Ospedali Riuniti Marche Nord (AORMN) - Presidio S. Salvatore
Pesaro, 61122, Italy
U.O. Ematologia Universitaria - Dip. Di Oncologia dei Trapianti - AOU Pisana
Pisa, 56126, Italy
Policlinico Universitario Campus Bio- Medico-U.O.C. di Ematologia Trapianto Cellule Staminali
Roma, 00128, Italy
East Nagoya Imaging Diagnosis Center
Nagoya, Aichi-ken, 464-0044, Japan
Nagoya Daini Red Cross Hospital
Nagoya, Aichi-ken, 466-8650, Japan
Akita University Hospital
Akita, Akita, 010-8543, Japan
Chiba Cancer Center
Chiba, Chiba, 260-8717, Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, Fukuoka, 810-8563, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, Fukuoka, 811-1395, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, 650-0047, Japan
National Hospital Organization Kanazawa Medical Center
Kanazawa, Ishikawa-ken, 920-8650, Japan
Kanazawa Advanced Medical Center
Kanazawa, Ishikawa-ken, 9200934, Japan
Showa University Northern Yokohama Hospital
Yokohama, Kanagawa, 224-8503, Japan
Kochi Medical School Hospital
Okocho, Nankoku, Kochi, 783-8505, Japan
National Hospital Organization Kumamoto Medical Center
Kumamoto, Kumamoto, 860-0008, Japan
Uozumi Clinic
Kumamoto, Kumamoto, 862-0941, Japan
Sendai Kousei Hospital
Sendai, Miyagi, 980-0873, Japan
National Hospital Organization Sendai Medical Center
Sendai, Miyagi, 983-8520, Japan
Aizawa Hospital
Matsumoto-shi, Nagano, 390-8510, Japan
Nagano Red Cross Hospital
Nagano, Nagano, 380-8582, Japan
National Hospital Organization Nagasaki Medical Center
Ōmura, Nagasaki, 856-8562, Japan
National Hospital Organization Osaka Minami Medical Center
Kawachi-Nagano, Osaka, 586-8521, Japan
Hanwa Dai 2 Senboku Hospital
Naka-ku Sakai, Osaka, 599-8271, Japan
Osaka City University Hospital
Osaka, Osaka, 545-8586, Japan
Tokushima University Hospital
Tokushima, Tokushima, 770-8503, Japan
National Hospital Organization Tokyo Medical Center
Meguro-Ku, Tokyo, 152-8902, Japan
Showa University Hospital
Shinagawa-ku, Tokyo, 142-8666, Japan
National Hospital Organization Disaster Medical Center
Tachikawa, Tokyo, 190-0014, Japan
Yamagata University Hospital
Yamagata, Yamagata, 990-9585, Japan
Fukuoka Wajiro PET Diagnostic Imaging Clinic
Fukuoka, 811-0213, Japan
National Hospital Organization Matsumoto Medical Center
Nagano, 399-8701, Japan
Musashimurayama Hospital
Tokyo, 2080022, Japan
Hammoud Hospital, University Medical Center
Saida, Southern Governate, Lebanon
Doctors Center Radiology
Beirut, Lebanon
Mount Lebanon Hospital
Beirut, Lebanon
Middle East Institute Of Health
El Metn, Lebanon
Ain Wazein Hospital
Mount Lebanon, Lebanon
Grupo Medico Camino S.C.
Mexico City, Mexico City, 03310, Mexico
Imagenus
Mexico City, Mexico City, 03340, Mexico
Isos Pharmacorp, S.A. de C.V.
Mexico City, Mexico City, 06700, Mexico
Centro Universitario de Imagen Diagnostica, Radiologia e Imagen del Hospital Universitario
Monterrey, Nuevo León, 64460, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, 64460, Mexico
Vely Grupo Medico Quirurgico, S.A. de C.V.
Cuautitlan Izacalli, State of Mexico, 54750, Mexico
Phylasis Clinicas Research S. de R.L. de C.V.
Cuautitlán Izcalli, State of Mexico, 54769, Mexico
Cirurgia y Ginecobstetricia de Oaxaca, S.A de C.V.
Oaxaca City, 68000, Mexico
Oaxaca Site Management Organization S.C.
Oaxaca City, 68000, Mexico
Hospital Angeles Puebla
Puebla City, 72190, Mexico
Cancerologia de Queretaro S.C.
Querétaro, 76090, Mexico
Hospital Infantil Teleton de Oncologia
Querétaro, 76140, Mexico
Hospital San Jose Norte
Querétaro, 76158, Mexico
Instituto Nacional de Enfermedades Neoplasicas
Surquillo, Lima region, 34, Peru
Pet Scan Peru
Lima, 18, Peru
Resocentro
Lima, 18, Peru
University of Philippines Manila-Philippine General Hospital
Manila, National Capital Region, 1000, Philippines
St. Luke's Medical Center
Quezon City, 1102, Philippines
Klinika Nowotworow Ukladu Chlonnego Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie
Warsaw, 02-781, Poland
Euromedic Wroclawskie Centrum Medyczne II
Wroclaw, 50-420, Poland
Euromedic Wroclawskie Centrum Medyczne III
Wroclaw, 50-557, Poland
Dolnoslaskie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku
Wroclaw, 53-439, Poland
Euromedic Wroclawskie Centrum Medyczne I
Wroclaw, 53-439, Poland
Apteka Dolnoslaskiego Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku
Wroclaw, 54-424, Poland
Unidade Local de Saude de Matosinhos E.P.E. - Hospital Pedro Hispano S.A.
Matosinhos Municipality, Porto District, 4464-513, Portugal
Hospital de Braga
Braga, 4710-243, Portugal
Hospital CUF Descobertas
Lisbon, 1998-018, Portugal
CIMC
Porto, 4050-075, Portugal
Dr. Campos Costa Clinic
Porto, 4050-075, Portugal
Centro Hospitalar do Porto-Hospital de Santo Antonio E.P.E.
Porto, 4099 - 001, Portugal
Instituto Portugues de Oncologia do Porto Francisco Gentil E.P.E
Porto, 4200-072, Portugal
Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
Vila Nova de Gaia, 4434-502, Portugal
Modern Radiology, PSC
Coto Laurel, PR, 00780, Puerto Rico
Ad-Vance Medical Research, LLC
Ponce, PR, 00717, Puerto Rico
Caribe MRI and CT
Ponce, PR, 00717, Puerto Rico
Policlinica de Diagnostic Rapid, Hematologie
Brasov, 500152, Romania
Policlinica de Diagnostic Rapid SA
Brasov, 500366, Romania
Spitalul Clinic Colentina
Bucharest, 020125, Romania
Hiperdia Ritmului
Bucharest, 021675, Romania
Affidea Fundeni
Bucharest, 022328, Romania
Affidea Romania SRL
Bucharest, 022328, Romania
Spitalul Clinic Coltea, Clinica de Hematologie
Bucharest, 030171, Romania
Institutul Oncologic Prof. Dr. Ion Chiricuta, Laborator Radiologie si Imagistica Medicala
Cluj-Napoca, 400015, Romania
Institutul Oncologic Prof. Dr. Ion Chiricuta, Sectia Oncologie Medicala
Cluj-Napoca, 400015, Romania
Clinica de Hematologie-Institutul Oncologic, Prof. Dr. Ion Chiricuta
Cluj-Napoca, 400124, Romania
CT Clinic S.R.L.
Cluj-Napoca, 400489, Romania
A.Tsyb Medical Radiological Research Centre -
Obninsk, Kaluga Oblast, 249036, Russia
State Healthcare Institution Republican Oncology Dispensary
Saransk, Mordovian Republic, 430032, Russia
"SBHI of NNR ""Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko"""
Nizhny Novgorod, Nizhniy Novgorod Region, 603126, Russia
LLC MC "MRT-Diagnostika"
Nizhny Novgorod, Nizhniy Novgorod Region, 603126, Russia
FSBI "Russian Research Centre of Radiology and Surgical Technologies" of MoH of RF
Saint Petersburg, Pesochniy TOWN, 197758, Russia
FSBI "Russian Research Centre of Radiology and Surgical Technologies"
Saint Petersburg, Pesochniy TOWN, 197758, Russia
FSBI "Russian Research Centre of Radiology and Surgical Technologies
Saint Petersburg, Pesochniy TOWN, 197758, Russia
FSBI 'Russian Research Centre of Radiology and Surgical Technologies
Saint Petersburg, Pesochniy TOWN, 197758, Russia
FSBI "Russian Research Centre of Radiology and Surgical Technologies n.a. A.M. Granov" of MoH of RF
Saint Petersburg, Pesochniy, 197758, Russia
FSBI "Russian Research Centre of Radiology and Surgical Technologies named after academician
Saint Petersburg, Pesochniy, 197758, Russia
FSBI "Russian Research Centre of Radiology and Surgical Technologies
Saint Petersburg, Pesochniy, 197758, Russia
FSBI 'National Medical Oncology Research Centre n.a. N.N.Petrov'
Saint Petersburg, Pos.pesochny, 197758, Russia
Branch office of LLC 'PET-Technology' at Ufa city
Ufa, Republic Bashkortostan, 450054, Russia
State Budgetary Healthcare Institution "Republican Clinical Oncology Dispensary of the Ministry
Ufa, Republic Bashkortostan, 450054, Russia
FSBI "Russian Research Centre of Radiology and Surgical Technologies" of MoH of RF
Pesochniy Town, Sankt-Peterburg, 197758, Russia
Private medical institution "Euromedservice"
Pushkin, Sankt-Peterburg, 196603, Russia
Federal State-Financed Institution 'North-Caucasian Research and Clinical Center'
Lermontov, Stavropol Kray, 357340, Russia
SBHI of Stavropol Region "Pyatigorsk Interdistrict Oncology Dispensary
Pyatigorsk, Stavropol Kray, 357502, Russia
"State Budget Healthcare Institution ""Chelyabinsk Regional Clinical Center of Oncology
Chelyabinsk, 454087, Russia
FSBSI 'N.N.Blokhin Russian Cancer Research Center' of MoH of RF
Moscow, 115478, Russia
Russian Cancer Research Centre them N.N. Blokhin
Moscow, 115478, Russia
LLC "VitaMed"
Moscow, 121309, Russia
SBHI of Moscow City Clinical Hospital n.a. S.P.Botkin of Healthcare Department of Moscow
Moscow, 125284, Russia
Ramsay Diagnostics
Moscow, 127473, Russia
Dr. Berezin Medical Institute
Saint Petersburg, 194214, Russia
State Budgetary Institution of Healthcare "Leningrad Regional Clinical Hospital"
Saint Petersburg, 194291, Russia
N.P. Bechtereva Institute of Human Brain of the Russian Academy of Sciences
Saint Petersburg, 197376, Russia
N.P. Bechtereva Institute of the Human Brain of the Russian Academy of Sciences
Saint Petersburg, 197376, Russia
Non-state healthcare institution "Road Clinical Hospital of Joint Stock Company "Russian Railways"
Saint-Petersurg, 195271, Russia
Yaroslavl State Medical Academy
Yaroslavl, 150010, Russia
GBUZ of Yaroslavl Region "Regional Clinical Hospital"
Yaroslavl, 150062, Russia
NIKSCH & PARTNERS t/a CAPITAL RADIOLOGY
Groenkloof, Gauteng, 0181, South Africa
The Medical Oncology Centre of Rosebank
Johannesburg, Gauteng, 2196, South Africa
Department of Medical Oncology, University of Pretoria, Steve Biko Academic Hospitals Complex
Pretoria, Gauteng, 0002, South Africa
Albert Alberts Stem Cell Transplant Centre
Pretoria, Gauteng, 0044, South Africa
Dr JN De Jong and Partners t/a East Rad
Pretoria, Gauteng, 0044, South Africa
NIKSCH & PARTNERS t/a CAPITAL RADIOLOGY
Pretoria, Gauteng, 0181, South Africa
Drs Sulman & Partners Specialist Radiologists
Rosebank, Gauteng, 2196, South Africa
Drs Bloch & Partners Incorporated
Sandton, Gauteng, 2191, South Africa
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do, 14068, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707, South Korea
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 54907, South Korea
Ulsan University Hospital
Ulsan, Korea, 44033, South Korea
Inje University Busan Paik Hospital
Busan, 47392, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Hospital Parc Tauli
Sabadell, Barcelona, 08208, Spain
Onkologikoa
Donostia / San Sebastian, Guipuzcoa, 20014, Spain
Hospital Universitario Sanitas La Zarzuela
Aravaca, Madrid, 28023, Spain
Hospital Rey Juan Carlos
Móstoles, Madrid, 28933, Spain
Hospital Clinico Universitario Virgen de la Arrixaca
El Palmar, Murcia, 30120, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, 30120, Spain
Hospital do Meixoeiro Complejo Hospitalario Universitario de Vigo
Vigo, Pontevedra, 36200, Spain
Complejo Hospitalario Universitario A Coruna
A Coruña, 15006, Spain
Hospital Modelo
A Coruña, 15011, Spain
Hospital Del Mar
Barcelona, 08003, Spain
Hospital Quiron de Barcelona, IEC
Barcelona, 08012, Spain
CETIR, Centre Medic
Barcelona, 08029, Spain
Radiodiagnostic CETIR - Clinica del Pilar
Barcelona, 08029, Spain
Hospital Universitario Puerta del Mar
Cadiz, 11009, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040, Spain
Hospital Universitario Sanitas La Moraleja
Madrid, 28050, Spain
Centro CIMES
Málaga, 29010, Spain
Hospital universitario Virgen de la Victoria
Málaga, 29010, Spain
Centro Mario Gallegos
Málaga, 29016, Spain
Complejo Hospitalario de Ourense. Hematología
Ourense, 32005, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
H. Quiron Zaragoza
Zaragoza, 50006, Spain
Hospital de Dia Quiron Zaragoza
Zaragoza, 50012, Spain
Universitatsspital Basel
Basel, 4031, Switzerland
Inselspital Bern
Bern, 3010, Switzerland
Apotheke, Spital STS AG
Thun, 3600, Switzerland
Onkologiezentrum Thun-Berner Oberland Spital Sts Ag
Thun, 3600, Switzerland
Kantonsapotheke Zuerich
Zurich, 8006, Switzerland
UniversitaetsSpital Zuerich
Zurich, 8091, Switzerland
Cardiology Unit,Department of Medicine, Faculty of Medicine, Ramathibodi Hospital,
Bangkok, 10400, Thailand
Department of Radiology, Ramathibodi Hospital
Bangkok, 10400, Thailand
National Cancer Institute
Bangkok, 10400, Thailand
Hacettepe Universitesi Tip Fakultesi Onkoloji Hastanesi
Ankara, 06100, Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Eg. ve Aras.
Ankara, 06200, Turkey (Türkiye)
Ultramar Tibbi Gorunteleme Merkezi
Ankara, 06420, Turkey (Türkiye)
Ultramar Tibbi Goruntuleme Merkezi
Ankara, 06420, Turkey (Türkiye)
Integra Gurses Teshis Tedavi ve Saglik Hizmetleri A.S.
Ankara, 06540, Turkey (Türkiye)
Adnan Menderes University Medical Faculty
Aydin, 09010, Turkey (Türkiye)
Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi
Gaziantep, 27310, Turkey (Türkiye)
Gaziantep Universitesi Sahinbey Arastirma ve Uygulama
Gaziantep, 27310, Turkey (Türkiye)
Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
Istanbul, 34093, Turkey (Türkiye)
Ege Universitesi Tip Fakultesi Ic Hastaliklari Anabilim Dali
Izmir, 35040, Turkey (Türkiye)
EGE-RAD Bilgisayarli Tomografi Ozel Saglik Hizmetleri ve Malzemeleri Tic.Ltd.Sti.
Izmir, 35040, Turkey (Türkiye)
Erciyes Universitesi Tip Fakultesi Nukleer Tip Laboratuvari
Kayseri, 38100, Turkey (Türkiye)
Erciyes Universitesi Tip Fakultesi Radyoloji Laboratuvari
Kayseri, 38100, Turkey (Türkiye)
Erciyes Universitesi Tip Fakultesi
Kayseri, 38100, Turkey (Türkiye)
Inonu Universitesi Tip Fakultesi Turgut Ozal Tip Merkezi
Malatya, 44280, Turkey (Türkiye)
Celal Bayar University Medical Faculty
Manisa, 45000, Turkey (Türkiye)
Ondokuz Mayis Universitesi Tip Fakultesi
Samsun, 55139, Turkey (Türkiye)
"MedX-Ray International Group" LLC
Obukhiv, Kyiv Oblast, 08720, Ukraine
"Mediks-rey International Group" LLC
Obukhiv District, Kyiv Oblast, 08720, Ukraine
"MedX-rey International Group" LLC
Obukhiv District, Kyiv Oblast, 08720, Ukraine
"Municipal Institution ""Chernivtsi Regional Clinical Oncology Center"",
Chernivtsi, 58013, Ukraine
MI 'City Dnipropetrovsk Multi-field Clin. Hospital #4 of DRC',
Dnipropetrovsk, 49102, Ukraine
Municipal Non-Profit Enterprise "Regional Oncology Centre"
Kharkiv, 61070, Ukraine
National Cancer Institute
Kyiv, 03022, Ukraine
"Central City Clinical Hospital, City Oncology Center, SHEI ""Uzhhorod National University"", Chair
Uzhhorod, 88017, Ukraine
Podilskyy Regional Oncology Center, Chemotherapy Department
Vinnytsia, 21029, Ukraine
Municipal Establishment 'Zaporizhzhia Regional Clinical Oncology Dispensary'
Zaporizhzhia, 69040, Ukraine
LLC "Diaservis"
Zaporizhzhia, 69076, Ukraine
Southend University Hospital NHS Foundation Trust
Westcliff-on-Sea, Essex, SS0 0RY, United Kingdom
Cobalt Diagnostic Imaging
Cheltenham, Glos., GL53 7AS, United Kingdom
Royal United Hospitals Bath NHS Foundation Trust
Bath, BA1 3NG, United Kingdom
Barts Health NHS Trust
London, EC1A 7BE, United Kingdom
Positron Emission Tomography (PET) Centre
Newcastle upon Tyne, NE4 6BE, United Kingdom
City Hospitals Sunderland NHS Foundation Trust-Sunderland Royal Hospital
Sunderland, SR4 7TP, United Kingdom
Diagnostic Imaging
Sunderland, SR4 7TP, United Kingdom
Related Publications (2)
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.
PMID: 34152584DERIVEDSharman 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.
PMID: 31820339DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 7, 2014
First Posted
August 11, 2014
Study Start
September 30, 2014
Primary Completion
October 23, 2017
Study Completion
April 19, 2018
Last Updated
June 20, 2019
Results First Posted
October 30, 2018
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will share
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.