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)

NCT ID: NCT02213263

Last Updated: 2019-06-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

394 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2018-04-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Follicular Lymphoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PF-05280586

Group Type EXPERIMENTAL

PF-05280586

Intervention Type BIOLOGICAL

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

MabThera®

Group Type ACTIVE_COMPARATOR

MabThera®

Intervention Type BIOLOGICAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PF-05280586

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

Intervention Type BIOLOGICAL

MabThera®

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

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kasturba Medical College and Hospital

Manipal, Karnataka, India

Site Status

Curie Manavata Cancer Centre

Nashik, Maharashtra, India

Site Status

Pacific Cancer Medical Center, Inc.

Anaheim, California, United States

Site Status

The Oncology Institute of Hope and Innovation

Anaheim, California, United States

Site Status

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

Corona, California, United States

Site Status

The Oncology Institute of Hope and Innovation

Downey, California, United States

Site Status

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

Fountain Valley, California, United States

Site Status

Global Cancer Research Institute (GCRI), Inc

Gilroy, California, United States

Site Status

Saint Louise Regional Hospital Radiology Department (Radiology Only)

Gilroy, California, United States

Site Status

South Valley Imaging Center (Imaging Only)

Gilroy, California, United States

Site Status

Los Angeles Hematology Oncology Medical Group

Glendale, California, United States

Site Status

The Oncology Institute of Hope and Innovation

Glendale, California, United States

Site Status

Los Angeles Hematology Oncology Medical Group

Glendale, California, United States

Site Status

The Oncology Institute of Hope and Innovation

Long Beach, California, United States

Site Status

Los Angeles Hematology Oncology Medical Group

Los Angeles, California, United States

Site Status

Los Angeles Hematology Oncology Medical Group

Los Angeles, California, United States

Site Status

The Oncology Institute of Hope and Innovation

Lynwood, California, United States

Site Status

The Oncology Institute of Hope and Innovation

Montebello, California, United States

Site Status

Comprehensive Cancer Center at Desert Regional Medical Center

Palm Springs, California, United States

Site Status

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

Redondo Beach, California, United States

Site Status

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

Riverside, California, United States

Site Status

Global Cancer Research Institute, Inc.

San Jose, California, United States

Site Status

O'Connor Hospital

San Jose, California, United States

Site Status

PET Imaging of San Jose (Imaging Only)

San Jose, California, United States

Site Status

The Oncology Institute of Hope and Innovation

Santa Ana, California, United States

Site Status

Torrance Memorial Medical Center

Torrance, California, United States

Site Status

The Oncology Institute of Hope and Innovation

Whittier, California, United States

Site Status

Innovative Clinical Research Institute (ICRI)

Whittier, California, United States

Site Status

Rocky Mountain Cancer Centers

Aurora, Colorado, United States

Site Status

Rocky Mountain Cancer Centers

Boulder, Colorado, United States

Site Status

Rocky Mountain Cancer Centers

Denver, Colorado, United States

Site Status

Rocky Mountain Cancer Center-Lakewood (Laboratory)

Lakewood, Colorado, United States

Site Status

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

Lakewood, Colorado, United States

Site Status

Rocky Mountain Cancer Centers

Lone Tree, Colorado, United States

Site Status

Rocky Mountain Cancer Center Pueblo

Pueblo, Colorado, United States

Site Status

John D. Archbold Memorial Hospital

Thomasville, Georgia, United States

Site Status

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

Thomasville, Georgia, United States

Site Status

Northwestern Medicine West Region

DeKalb, Illinois, United States

Site Status

Cancer Center,Northwestern Medicine, West Region

Geneva, Illinois, United States

Site Status

Cancer Center of Kansas

Chanute, Kansas, United States

Site Status

Cancer Center of Kansas

Dodge City, Kansas, United States

Site Status

Cancer Center of Kansas

El Dorado, Kansas, United States

Site Status

Cancer Center of Kansas

Independence, Kansas, United States

Site Status

Cancer Center of Kansas

Kingman, Kansas, United States

Site Status

Cancer Center of Kansas

Liberal, Kansas, United States

Site Status

Cancer Center of Kansas

McPherson, Kansas, United States

Site Status

Cancer Center of Kansas

Newton, Kansas, United States

Site Status

The University of Kansas Cancer Center

Overland Park, Kansas, United States

Site Status

Cancer Center of Kansas

Parsons, Kansas, United States

Site Status

Cancer Center of Kansas

Salina, Kansas, United States

Site Status

Cancer Center of Kansas

Wellington, Kansas, United States

Site Status

Cancer Center of Kansas

Wichita, Kansas, United States

Site Status

Cancer Center of Kansas

Wichita, Kansas, United States

Site Status

Cancer Center Of Kansas

Winfield, Kansas, United States

Site Status

PET/CT facility Seton Imaging Center

Baltimore, Maryland, United States

Site Status

Saint Agnes Hospital

Baltimore, Maryland, United States

Site Status

Rcca Md Llc

Bethesda, Maryland, United States

Site Status

Holy Cross Hospital Resource Center

Silver Spring, Maryland, United States

Site Status

Holy Cross Hospital Hospital Pharmacy

Silver Spring, Maryland, United States

Site Status

Holy Cross Hospital

Silver Spring, Maryland, United States

Site Status

Maryland Oncology Hematology, P.A.

Wheaton, Maryland, United States

Site Status

The University of Kansas Cancer Center

Kansas City, Missouri, United States

Site Status

The University of Kansas Cancer Center

Kansas City, Missouri, United States

Site Status

The University of Kansas Cancer Center

Lee's Summit, Missouri, United States

Site Status

Saint Francis Medical Center, Saint Francis Cancer Treatment Center

Grand Island, Nebraska, United States

Site Status

Saint Francis Medical Center

Grand Island, Nebraska, United States

Site Status

Saint Francis Medical Center, Saint Francis Cancer Treatment Center

Hastings, Nebraska, United States

Site Status

Comprehensive Cancer Centers of Nevada

Henderson, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada

Henderson, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

Site Status

Brody School of Medicine at East Carolina University

Greenville, North Carolina, United States

Site Status

Vidant Medical Center Pharmacy

Greenville, North Carolina, United States

Site Status

Vidant Medical Center

Greenville, North Carolina, United States

Site Status

Toledo Clinic Cancer Center - Maumee

Maumee, Ohio, United States

Site Status

Toledo Clinic Cancer Center - Toledo

Toledo, Ohio, United States

Site Status

Toledo Clinic, Inc.

Toledo, Ohio, United States

Site Status

Willamette Valley Cancer Institute and Research Center

Eugene, Oregon, United States

Site Status

University of Tennessee Medical Center

Knoxville, Tennessee, United States

Site Status

San Antonio Military Medical Center- Department of Pharmacy

Fort Sam Houston, Texas, United States

Site Status

San Antonio Military Medical Center- Department of Radiology

Fort Sam Houston, Texas, United States

Site Status

San Antonio Military Medical Center

Fort Sam Houston, Texas, United States

Site Status

Investigational Products Center (I PC)

Fort Worth, Texas, United States

Site Status

Investigational Products Center (IPC)

Fort Worth, Texas, United States

Site Status

Millennium Oncology

Houston, Texas, United States

Site Status

US Oncology Investigational Products Center (IPC)

Irving, Texas, United States

Site Status

Millennium Oncology

Kingwood, Texas, United States

Site Status

Texas Oncology - Longview Cancer Center

Longview, Texas, United States

Site Status

Millennium Oncology

Shenandoah, Texas, United States

Site Status

Millennium Oncology

The Woodlands, Texas, United States

Site Status

Texas Oncology-Tyler

Tyler, Texas, United States

Site Status

Yakima Valley Memorial Hospital/North Star Lodge Cancer Center

Yakima, Washington, United States

Site Status

Krankenhaus der Barmherzigen Schwestern Linz

Linz, , Austria

Site Status

Kepler Universitaetsklinikum GmbH

Linz, , Austria

Site Status

Kepler Universitaetsklinikum GmbH

Linz, , Austria

Site Status

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

Lyasny, Minsk Oblast, Belarus

Site Status

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

Lyasny, Minsk Oblast, Belarus

Site Status

Healthcare Institution "Brest Regional Oncologic Dispensary"

Brest, , Belarus

Site Status

Healthcare Institution 'Minsk City Clinical Oncology Dispensary'

Minsk, , Belarus

Site Status

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

Republic of Belarus, , Belarus

Site Status

Hopital Erasme

Brussels, , Belgium

Site Status

Nuclear Medicine Department

Brussels, , Belgium

Site Status

Grand Hopital de Charleroi-Site Notre-Dame

Charleroi, , Belgium

Site Status

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

Charleroi, , Belgium

Site Status

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

Charleroi, , Belgium

Site Status

Pharmacy Department, Centre Hospitalier De Jolimont - Lobbes

La Louviere (Haine-Saint Paul), , Belgium

Site Status

Centre Hospitalier de Jolimont - Lobbes

La Louviere (Haine-Saint-Paul), , Belgium

Site Status

Radiology Department

La Louviere (Haine-Saint-Paul), , Belgium

Site Status

C.H.U. Ambroise Pare

Mons, , Belgium

Site Status

Pharmacy Department, CHU Ambroise Pare

Mons, , Belgium

Site Status

Hospital Santa Izabel - Setor de Bioimagem

Salvador, Estado de Bahia, Brazil

Site Status

Hospital Santa Izabel / Santa Casa de Misericordia da Bahia

Salvador, Estado de Bahia, Brazil

Site Status

Clinica Multimagem

Goiânia, Goiás, Brazil

Site Status

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

Goiânia, Goiás, Brazil

Site Status

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

Belo Horizonte, Minas Gerais, Brazil

Site Status

Hospital das Clinicas Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Site Status

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

Belo Horizonte, Minas Gerais, Brazil

Site Status

Central de Misturas Intravenosas do Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Hospital de Clinicas de Porto Alegre - Centro de Pesquisa Clinica

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Servico de Radiologia do Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

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

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

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

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

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

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

CEMEDI

Campinas, São Paulo, Brazil

Site Status

Instituto Radium

Campinas, São Paulo, Brazil

Site Status

CAEP - Centro Avancado de Estudos e Pesquisas LTDA

Campinas, São Paulo, Brazil

Site Status

Hospital e Maternidade Madre Theodora LTDA

Campinas, São Paulo, Brazil

Site Status

CENNI Oncologia

Campinas, São Paulo, Brazil

Site Status

Fundacao Amaral Carvalho / Fundacao Dr. Amaral Carvalho

Jaú, São Paulo, Brazil

Site Status

Fundacao Amaral Carvalho / Fundacao Dr. Amaral Carvalho

Jaú, São Paulo, Brazil

Site Status

Unidade de Quimioterapia

Jaú, São Paulo, Brazil

Site Status

Casa da Esperanca

Santo André, São Paulo, Brazil

Site Status

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

Santo André, São Paulo, Brazil

Site Status

Tecnolab

São Bernardo do Campo, São Paulo, Brazil

Site Status

IEP São Lucas (Pharmacy)

São Paulo, São Paulo, Brazil

Site Status

Hospital Bandeirantes

São Paulo, São Paulo, Brazil

Site Status

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

São Paulo, São Paulo, Brazil

Site Status

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

São Paulo, São Paulo, Brazil

Site Status

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

São Paulo, , Brazil

Site Status

Fleury

São Paulo, , Brazil

Site Status

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

Zagreb, , Croatia

Site Status

University Hospital Center Zagreb, Department of Pathology and Cytology

Zagreb, , Croatia

Site Status

University Hospital Center Zagreb, Department of Radiology

Zagreb, , Croatia

Site Status

University Hospital Centre "Sestre Milosrdnice"

Zagreb, , Croatia

Site Status

University Hospital Centre Zagreb

Zagreb, , Croatia

Site Status

CHU Marseille Hopital de La Conception

Marseille, Marseille Cedex 05, France

Site Status

CH de Mulhouse, Hopital Emile Muller

Mulhouse, Mulhouse Cedex, France

Site Status

Hopital Duchenne Chu - Boulogne Sur Mer

Boulogne-sur-Mer, NAP, France

Site Status

Hopital Duchenne Chu - Boulogne Sur Mer

Boulogne-sur-Mer, , France

Site Status

Centre Hospitalier De Bourg En Bresse

Bourg-en-Bresse, , France

Site Status

Hopital Morvan-CHU Brest- Service Hematologie Clinique

Brest, , France

Site Status

Centre Hospitalier Universitaire Cote de Nacre

Caen, , France

Site Status

Centre Hospitalier du Mans

Le Mans, , France

Site Status

Clinique de la Sauvegarde

Lyon, , France

Site Status

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

Tbilisi, , Georgia

Site Status

LTD "Research Institute of Clinical Medicine"

Tbilisi, , Georgia

Site Status

High Technology Medical Center, University Clinic

Tbilisi, , Georgia

Site Status

Charite - Universitaetsmedizin Berlin

Berlin, , Germany

Site Status

Charite - Universitatsmedizin Berlin - Campus Benjamin Franklin

Berlin, , Germany

Site Status

Charite - Universitaetsmedizin Berlin, Campus Virchow-Klinikum

Berlin, , Germany

Site Status

Charite - Universitatsmedizin Berlin, Campus Virchow-Klinikum

Berlin, , Germany

Site Status

Charite - Universitatsmedizin Berlin

Berlin, , Germany

Site Status

Klinikum Chemnitz gGmbH - Institut fuer Interventionelle Radiologie und Neuroradiologie

Chemnitz, , Germany

Site Status

Klinikum Chemnitz gGmbH

Chemnitz, , Germany

Site Status

Klinikum Chemnitz gGmbH - Klinik fuer Nuklearmedizin

Chemnitz, , Germany

Site Status

Klinikum Chemnitz gGmbH - Zentralapotheke

Chemnitz, , Germany

Site Status

Praxis im Koeln Triangle

Cologne, , Germany

Site Status

Universitaetsklinikum Essen (AoeR)

Essen, , Germany

Site Status

Universitatsklinikum Essen (AoR)

Essen, , Germany

Site Status

DokuSan Gesellschaft fuer Medizinische Studien mbH & Co. KG

Herne, , Germany

Site Status

Apotheke des St. Anna Hospital

Herne, , Germany

Site Status

EVK Eickel

Herne, , Germany

Site Status

Gemeinschaftspraxis fuer Diagnostische Radiologie und Nuklearmedizin

Mutlangen, , Germany

Site Status

Kliniken Ostalb, Stauferklinikum Schwaebisch Gmuend, Zentrum fuer Innere Medizin

Mutlangen, , Germany

Site Status

Stauferklinikum Schwaebisch Gmuend, Apotheke

Mutlangen, , Germany

Site Status

Universitaetsmedizin Rostock

Rostock, , Germany

Site Status

Klinikum Stuttgart, Klinik fuer Nuklearmedizin

Stuttgart, , Germany

Site Status

Vinzenz von Paul Kliniken gGmbH

Stuttgart, , Germany

Site Status

Radiologie Rhein-Sieg

Troisdorf, , Germany

Site Status

Ueberoertliche Berufsausuebungsgemeinschaft Drs. med. Helmut Forstbauer

Troisdorf, , Germany

Site Status

Zentralapotheke

Troisdorf, , Germany

Site Status

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

Athens, , Greece

Site Status

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

Athens, , Greece

Site Status

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

Athens, , Greece

Site Status

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

Athens, , Greece

Site Status

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

Athens, , Greece

Site Status

Bioiatriki S.A.

Athens, , Greece

Site Status

Bioiatriki

Athens, , Greece

Site Status

General Hospital of Athens 'Laiko'

Athens, , Greece

Site Status

"""ATTIKON"" Gen. Univ. Hosp"

Athens, , Greece

Site Status

"ATTIKON'' Gen. Univ. Hosp.

Chaidari, Athens, , Greece

Site Status

Magnitiki Patron

Pátrai, , Greece

Site Status

University General Hospital of Patras

Pátrai, , Greece

Site Status

Super Scan Imaging Centre

Surat, Gujarat, India

Site Status

Pathology Department, Unique Hospital Multispeciality & Research Institute

Surat, Gujarat, India

Site Status

Zircon- BIC Imaging Centre

Surat, Gujarat, India

Site Status

HealthCare Global Enterprises Limited

Bangalore, Karnataka, India

Site Status

Mangalore Institute of Oncology

Mangalore, Karnataka, India

Site Status

Department of Radiology, Curie Manavata Cancer Centre

Nashik, Maharashtra, India

Site Status

Department of Radiology

Pune, Maharashtra, India

Site Status

Jehangir Clinical Development Centre Pvt. Ltd.

Pune, Maharashtra, India

Site Status

Ruby Hall clinic

Pune, Maharashtra, India

Site Status

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

Jaipur, Rajasthan, India

Site Status

Apollo Speciality Hospital

Chennai, Tamil Nadu, India

Site Status

Department of Radiology

Chennai, Tamil Nadu, India

Site Status

Global Hospitals

Hyderabad, Telangana, India

Site Status

Vijaya Diagnostic Centre

Hyderabad, Telangana, India

Site Status

N.R.S Medical College and Hospital

Kolkata, West Bengal, India

Site Status

Spandan PET-CT Unit

Kolkata, West Bengal, India

Site Status

Rajiv Gandhi Cancer Institute & Research Center (RGCIRC)

New Delhi, , India

Site Status

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

Cremona, CR, Italy

Site Status

IRST - IRCCS U. O. Oncologia Medica

Meldola, FC, Italy

Site Status

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

Genova, GE, Italy

Site Status

Unita di Ricerca Clinica

Monza, MB, Italy

Site Status

Istituto Europeo di Oncologia

Milan, MI, Italy

Site Status

Unità semplice di Medicina Nucleare

Latina, NAP, Italy

Site Status

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

Torrette Ancona, Palermo, Italy

Site Status

Az Ospedaliera Santa Maria

Terni, PG, Italy

Site Status

Medicina nucleare

Reggio Emilia, Reggio, Italy

Site Status

Radiologia

Reggio Emilia, Reggio, Italy

Site Status

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

Reggio Emilia, Reggio, Italy

Site Status

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

Rome, ROME RM, Italy

Site Status

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

Genova, , Italy

Site Status

SC Ematologia, Fondazione IRCCS Ist Nazionale dei Tumori

Milan, , Italy

Site Status

Padiglione 1, Torre delle medicine, 6 piano

Parma, , Italy

Site Status

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

Pesaro, , Italy

Site Status

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

Pisa, , Italy

Site Status

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

Roma, , Italy

Site Status

East Nagoya Imaging Diagnosis Center

Nagoya, Aichi-ken, Japan

Site Status

Nagoya Daini Red Cross Hospital

Nagoya, Aichi-ken, Japan

Site Status

Akita University Hospital

Akita, Akita, Japan

Site Status

Chiba Cancer Center

Chiba, Chiba, Japan

Site Status

National Hospital Organization Kyushu Medical Center

Fukuoka, Fukuoka, Japan

Site Status

National Hospital Organization Kyushu Cancer Center

Fukuoka, Fukuoka, Japan

Site Status

Kobe City Medical Center General Hospital

Kobe, Hyōgo, Japan

Site Status

National Hospital Organization Kanazawa Medical Center

Kanazawa, Ishikawa-ken, Japan

Site Status

Kanazawa Advanced Medical Center

Kanazawa, Ishikawa-ken, Japan

Site Status

Showa University Northern Yokohama Hospital

Yokohama, Kanagawa, Japan

Site Status

Kochi Medical School Hospital

Okocho, Nankoku, Kochi, Japan

Site Status

National Hospital Organization Kumamoto Medical Center

Kumamoto, Kumamoto, Japan

Site Status

Uozumi Clinic

Kumamoto, Kumamoto, Japan

Site Status

Sendai Kousei Hospital

Sendai, Miyagi, Japan

Site Status

National Hospital Organization Sendai Medical Center

Sendai, Miyagi, Japan

Site Status

Aizawa Hospital

Matsumoto-shi, Nagano, Japan

Site Status

Nagano Red Cross Hospital

Nagano, Nagano, Japan

Site Status

National Hospital Organization Nagasaki Medical Center

Ōmura, Nagasaki, Japan

Site Status

National Hospital Organization Osaka Minami Medical Center

Kawachi-Nagano, Osaka, Japan

Site Status

Hanwa Dai 2 Senboku Hospital

Naka-ku Sakai, Osaka, Japan

Site Status

Osaka City University Hospital

Osaka, Osaka, Japan

Site Status

Tokushima University Hospital

Tokushima, Tokushima, Japan

Site Status

National Hospital Organization Tokyo Medical Center

Meguro-Ku, Tokyo, Japan

Site Status

Showa University Hospital

Shinagawa-ku, Tokyo, Japan

Site Status

National Hospital Organization Disaster Medical Center

Tachikawa, Tokyo, Japan

Site Status

Yamagata University Hospital

Yamagata, Yamagata, Japan

Site Status

Fukuoka Wajiro PET Diagnostic Imaging Clinic

Fukuoka, , Japan

Site Status

National Hospital Organization Matsumoto Medical Center

Nagano, , Japan

Site Status

Musashimurayama Hospital

Tokyo, , Japan

Site Status

Hammoud Hospital, University Medical Center

Saida, Southern Governate, Lebanon

Site Status

Doctors Center Radiology

Beirut, , Lebanon

Site Status

Mount Lebanon Hospital

Beirut, , Lebanon

Site Status

Middle East Institute Of Health

El Metn, , Lebanon

Site Status

Ain Wazein Hospital

Mount Lebanon, , Lebanon

Site Status

Grupo Medico Camino S.C.

Mexico City, Mexico City, Mexico

Site Status

Imagenus

Mexico City, Mexico City, Mexico

Site Status

Isos Pharmacorp, S.A. de C.V.

Mexico City, Mexico City, Mexico

Site Status

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

Monterrey, Nuevo León, Mexico

Site Status

Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

Monterrey, Nuevo León, Mexico

Site Status

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

Cuautitlan Izacalli, State of Mexico, Mexico

Site Status

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

Cuautitlán Izcalli, State of Mexico, Mexico

Site Status

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

Oaxaca City, , Mexico

Site Status

Oaxaca Site Management Organization S.C.

Oaxaca City, , Mexico

Site Status

Hospital Angeles Puebla

Puebla City, , Mexico

Site Status

Cancerologia de Queretaro S.C.

Querétaro, , Mexico

Site Status

Hospital Infantil Teleton de Oncologia

Querétaro, , Mexico

Site Status

Hospital San Jose Norte

Querétaro, , Mexico

Site Status

Instituto Nacional de Enfermedades Neoplasicas

Surquillo, Lima region, Peru

Site Status

Pet Scan Peru

Lima, , Peru

Site Status

Resocentro

Lima, , Peru

Site Status

University of Philippines Manila-Philippine General Hospital

Manila, National Capital Region, Philippines

Site Status

St. Luke's Medical Center

Quezon City, , Philippines

Site Status

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

Warsaw, , Poland

Site Status

Euromedic Wroclawskie Centrum Medyczne II

Wroclaw, , Poland

Site Status

Euromedic Wroclawskie Centrum Medyczne III

Wroclaw, , Poland

Site Status

Dolnoslaskie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku

Wroclaw, , Poland

Site Status

Euromedic Wroclawskie Centrum Medyczne I

Wroclaw, , Poland

Site Status

Apteka Dolnoslaskiego Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku

Wroclaw, , Poland

Site Status

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

Matosinhos Municipality, Porto District, Portugal

Site Status

Hospital de Braga

Braga, , Portugal

Site Status

Hospital CUF Descobertas

Lisbon, , Portugal

Site Status

CIMC

Porto, , Portugal

Site Status

Dr. Campos Costa Clinic

Porto, , Portugal

Site Status

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

Porto, , Portugal

Site Status

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

Porto, , Portugal

Site Status

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

Vila Nova de Gaia, , Portugal

Site Status

Modern Radiology, PSC

Coto Laurel, PR, Puerto Rico

Site Status

Ad-Vance Medical Research, LLC

Ponce, PR, Puerto Rico

Site Status

Caribe MRI and CT

Ponce, PR, Puerto Rico

Site Status

Policlinica de Diagnostic Rapid, Hematologie

Brasov, , Romania

Site Status

Policlinica de Diagnostic Rapid SA

Brasov, , Romania

Site Status

Spitalul Clinic Colentina

Bucharest, , Romania

Site Status

Hiperdia Ritmului

Bucharest, , Romania

Site Status

Affidea Fundeni

Bucharest, , Romania

Site Status

Affidea Romania SRL

Bucharest, , Romania

Site Status

Spitalul Clinic Coltea, Clinica de Hematologie

Bucharest, , Romania

Site Status

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

Cluj-Napoca, , Romania

Site Status

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

Cluj-Napoca, , Romania

Site Status

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

Cluj-Napoca, , Romania

Site Status

CT Clinic S.R.L.

Cluj-Napoca, , Romania

Site Status

A.Tsyb Medical Radiological Research Centre -

Obninsk, Kaluga Oblast, Russia

Site Status

State Healthcare Institution Republican Oncology Dispensary

Saransk, Mordovian Republic, Russia

Site Status

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

Nizhny Novgorod, Nizhniy Novgorod Region, Russia

Site Status

LLC MC "MRT-Diagnostika"

Nizhny Novgorod, Nizhniy Novgorod Region, Russia

Site Status

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

Saint Petersburg, Pesochniy TOWN, Russia

Site Status

FSBI "Russian Research Centre of Radiology and Surgical Technologies"

Saint Petersburg, Pesochniy TOWN, Russia

Site Status

FSBI "Russian Research Centre of Radiology and Surgical Technologies

Saint Petersburg, Pesochniy TOWN, Russia

Site Status

FSBI 'Russian Research Centre of Radiology and Surgical Technologies

Saint Petersburg, Pesochniy TOWN, Russia

Site Status

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

Saint Petersburg, Pesochniy, Russia

Site Status

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

Saint Petersburg, Pesochniy, Russia

Site Status

FSBI "Russian Research Centre of Radiology and Surgical Technologies

Saint Petersburg, Pesochniy, Russia

Site Status

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

Saint Petersburg, Pos.pesochny, Russia

Site Status

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

Ufa, Republic Bashkortostan, Russia

Site Status

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

Ufa, Republic Bashkortostan, Russia

Site Status

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

Pesochniy Town, Sankt-Peterburg, Russia

Site Status

Private medical institution "Euromedservice"

Pushkin, Sankt-Peterburg, Russia

Site Status

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

Lermontov, Stavropol Kray, Russia

Site Status

SBHI of Stavropol Region "Pyatigorsk Interdistrict Oncology Dispensary

Pyatigorsk, Stavropol Kray, Russia

Site Status

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

Chelyabinsk, , Russia

Site Status

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

Moscow, , Russia

Site Status

Russian Cancer Research Centre them N.N. Blokhin

Moscow, , Russia

Site Status

LLC "VitaMed"

Moscow, , Russia

Site Status

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

Moscow, , Russia

Site Status

Ramsay Diagnostics

Moscow, , Russia

Site Status

Dr. Berezin Medical Institute

Saint Petersburg, , Russia

Site Status

State Budgetary Institution of Healthcare "Leningrad Regional Clinical Hospital"

Saint Petersburg, , Russia

Site Status

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

Saint Petersburg, , Russia

Site Status

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

Saint Petersburg, , Russia

Site Status

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

Saint-Petersurg, , Russia

Site Status

Yaroslavl State Medical Academy

Yaroslavl, , Russia

Site Status

GBUZ of Yaroslavl Region "Regional Clinical Hospital"

Yaroslavl, , Russia

Site Status

NIKSCH & PARTNERS t/a CAPITAL RADIOLOGY

Groenkloof, Gauteng, South Africa

Site Status

The Medical Oncology Centre of Rosebank

Johannesburg, Gauteng, South Africa

Site Status

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

Pretoria, Gauteng, South Africa

Site Status

Albert Alberts Stem Cell Transplant Centre

Pretoria, Gauteng, South Africa

Site Status

Dr JN De Jong and Partners t/a East Rad

Pretoria, Gauteng, South Africa

Site Status

NIKSCH & PARTNERS t/a CAPITAL RADIOLOGY

Pretoria, Gauteng, South Africa

Site Status

Drs Sulman & Partners Specialist Radiologists

Rosebank, Gauteng, South Africa

Site Status

Drs Bloch & Partners Incorporated

Sandton, Gauteng, South Africa

Site Status

Hallym University Sacred Heart Hospital

Anyang-si, Gyeonggi-do, South Korea

Site Status

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Site Status

Ulsan University Hospital

Ulsan, Korea, South Korea

Site Status

Inje University Busan Paik Hospital

Busan, , South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Samsung Medical Center

Seoul, , South Korea

Site Status

Hospital Parc Tauli

Sabadell, Barcelona, Spain

Site Status

Onkologikoa

Donostia / San Sebastian, Guipuzcoa, Spain

Site Status

Hospital Universitario Sanitas La Zarzuela

Aravaca, Madrid, Spain

Site Status

Hospital Rey Juan Carlos

Móstoles, Madrid, Spain

Site Status

Hospital Clinico Universitario Virgen de la Arrixaca

El Palmar, Murcia, Spain

Site Status

Hospital Clínico Universitario Virgen de la Arrixaca

El Palmar, Murcia, Spain

Site Status

Hospital do Meixoeiro Complejo Hospitalario Universitario de Vigo

Vigo, Pontevedra, Spain

Site Status

Complejo Hospitalario Universitario A Coruna

A Coruña, , Spain

Site Status

Hospital Modelo

A Coruña, , Spain

Site Status

Hospital Del Mar

Barcelona, , Spain

Site Status

Hospital Quiron de Barcelona, IEC

Barcelona, , Spain

Site Status

CETIR, Centre Medic

Barcelona, , Spain

Site Status

Radiodiagnostic CETIR - Clinica del Pilar

Barcelona, , Spain

Site Status

Hospital Universitario Puerta del Mar

Cadiz, , Spain

Site Status

Hospital Universitario Fundacion Jimenez Diaz

Madrid, , Spain

Site Status

Hospital Universitario Sanitas La Moraleja

Madrid, , Spain

Site Status

Centro CIMES

Málaga, , Spain

Site Status

Hospital universitario Virgen de la Victoria

Málaga, , Spain

Site Status

Centro Mario Gallegos

Málaga, , Spain

Site Status

Complejo Hospitalario de Ourense. Hematología

Ourense, , Spain

Site Status

Hospital Universitario Virgen del Rocio

Seville, , Spain

Site Status

H. Quiron Zaragoza

Zaragoza, , Spain

Site Status

Hospital de Dia Quiron Zaragoza

Zaragoza, , Spain

Site Status

Universitatsspital Basel

Basel, , Switzerland

Site Status

Inselspital Bern

Bern, , Switzerland

Site Status

Apotheke, Spital STS AG

Thun, , Switzerland

Site Status

Onkologiezentrum Thun-Berner Oberland Spital Sts Ag

Thun, , Switzerland

Site Status

Kantonsapotheke Zuerich

Zurich, , Switzerland

Site Status

UniversitaetsSpital Zuerich

Zurich, , Switzerland

Site Status

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

Bangkok, , Thailand

Site Status

Department of Radiology, Ramathibodi Hospital

Bangkok, , Thailand

Site Status

National Cancer Institute

Bangkok, , Thailand

Site Status

Hacettepe Universitesi Tip Fakultesi Onkoloji Hastanesi

Ankara, , Turkey (Türkiye)

Site Status

Dr. Abdurrahman Yurtaslan Ankara Onkoloji Eg. ve Aras.

Ankara, , Turkey (Türkiye)

Site Status

Ultramar Tibbi Gorunteleme Merkezi

Ankara, , Turkey (Türkiye)

Site Status

Ultramar Tibbi Goruntuleme Merkezi

Ankara, , Turkey (Türkiye)

Site Status

Integra Gurses Teshis Tedavi ve Saglik Hizmetleri A.S.

Ankara, , Turkey (Türkiye)

Site Status

Adnan Menderes University Medical Faculty

Aydin, , Turkey (Türkiye)

Site Status

Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi

Gaziantep, , Turkey (Türkiye)

Site Status

Gaziantep Universitesi Sahinbey Arastirma ve Uygulama

Gaziantep, , Turkey (Türkiye)

Site Status

Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi

Istanbul, , Turkey (Türkiye)

Site Status

Ege Universitesi Tip Fakultesi Ic Hastaliklari Anabilim Dali

Izmir, , Turkey (Türkiye)

Site Status

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

Izmir, , Turkey (Türkiye)

Site Status

Erciyes Universitesi Tip Fakultesi Nukleer Tip Laboratuvari

Kayseri, , Turkey (Türkiye)

Site Status

Erciyes Universitesi Tip Fakultesi Radyoloji Laboratuvari

Kayseri, , Turkey (Türkiye)

Site Status

Erciyes Universitesi Tip Fakultesi

Kayseri, , Turkey (Türkiye)

Site Status

Inonu Universitesi Tip Fakultesi Turgut Ozal Tip Merkezi

Malatya, , Turkey (Türkiye)

Site Status

Celal Bayar University Medical Faculty

Manisa, , Turkey (Türkiye)

Site Status

Ondokuz Mayis Universitesi Tip Fakultesi

Samsun, , Turkey (Türkiye)

Site Status

"MedX-Ray International Group" LLC

Obukhiv, Kyiv Oblast, Ukraine

Site Status

"Mediks-rey International Group" LLC

Obukhiv District, Kyiv Oblast, Ukraine

Site Status

"MedX-rey International Group" LLC

Obukhiv District, Kyiv Oblast, Ukraine

Site Status

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

Chernivtsi, , Ukraine

Site Status

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

Dnipropetrovsk, , Ukraine

Site Status

Municipal Non-Profit Enterprise "Regional Oncology Centre"

Kharkiv, , Ukraine

Site Status

National Cancer Institute

Kyiv, , Ukraine

Site Status

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

Uzhhorod, , Ukraine

Site Status

Podilskyy Regional Oncology Center, Chemotherapy Department

Vinnytsia, , Ukraine

Site Status

Municipal Establishment 'Zaporizhzhia Regional Clinical Oncology Dispensary'

Zaporizhzhia, , Ukraine

Site Status

LLC "Diaservis"

Zaporizhzhia, , Ukraine

Site Status

Southend University Hospital NHS Foundation Trust

Westcliff-on-Sea, Essex, United Kingdom

Site Status

Cobalt Diagnostic Imaging

Cheltenham, Glos., United Kingdom

Site Status

Royal United Hospitals Bath NHS Foundation Trust

Bath, , United Kingdom

Site Status

Barts Health NHS Trust

London, , United Kingdom

Site Status

Positron Emission Tomography (PET) Centre

Newcastle upon Tyne, , United Kingdom

Site Status

City Hospitals Sunderland NHS Foundation Trust-Sunderland Royal Hospital

Sunderland, , United Kingdom

Site Status

Diagnostic Imaging

Sunderland, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Austria Belarus Belgium Brazil Croatia France Georgia Germany Greece India Italy Japan Lebanon Mexico Peru Philippines Poland Portugal Puerto Rico Romania Russia South Africa South Korea Spain Switzerland Thailand Turkey (Türkiye) Ukraine United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 34152584 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31820339 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

Access external resources that provide additional context or updates about the study.

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B3281006

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

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2014-000132-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

REFLECTIONS

Identifier Type: OTHER

Identifier Source: secondary_id

B3281006

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Primary Rituximab and Maintenance
NCT00140582 COMPLETED PHASE3