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

18 de junho de 2019 atualizado por: Pfizer

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

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

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

394

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: PF-05280586
Biológico: PF-05280586
PF-05280586 (rituximab-Pfizer) concentrate for solution for infusion 375mg/m2 administered via IV infusion on Days 1, 8, 15, and 22
Comparador Ativo: MabThera®
Biológico: MabThera®
MabThera® (rituximab-EU) concentrate for solution for infusion 375mg/m2 administered via IV infusion on Days 1, 8, 15, and 22

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Overall Response Rate (ORR): Percentage of Participants With Overall Response (OR) at Week 26
Prazo: 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

Medidas de resultados secundários

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

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Patrocinador

Pfizer

Publicações e links úteis

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Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

30 de setembro de 2014

Conclusão Primária (Real)

23 de outubro de 2017

Conclusão do estudo (Real)

19 de abril de 2018

Datas de inscrição no estudo

Enviado pela primeira vez

7 de agosto de 2014

Enviado pela primeira vez que atendeu aos critérios de CQ

7 de agosto de 2014

Primeira postagem (Estimativa)

11 de agosto de 2014

Atualizações de registro de estudo

Última Atualização Postada (Real)

20 de junho de 2019

Última atualização enviada que atendeu aos critérios de controle de qualidade

18 de junho de 2019

Última verificação

1 de junho de 2019

Mais Informações

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Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • B3281006
  • 2014-000132-41 (Número EudraCT)
  • REFLECTIONS (Outro identificador: Alias Study Number)

Plano para dados de participantes individuais (IPD)

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Descrição do plano IPD

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.

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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