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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 июня 2019 г. обновлено: 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.

Обзор исследования

Статус

Завершенный

Тип исследования

Интервенционный

Регистрация (Действительный)

394

Фаза

  • Фаза 3

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Двойной

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: PF-05280586
PF-05280586 (rituximab-Pfizer) concentrate for solution for infusion 375mg/m2 administered via IV infusion on Days 1, 8, 15, and 22
Активный компаратор: Мабтера®
MabThera® (rituximab-EU) concentrate for solution for infusion 375mg/m2 administered via IV infusion on Days 1, 8, 15, and 22

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Overall Response Rate (ORR): Percentage of Participants With Overall Response (OR) at Week 26
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

30 сентября 2014 г.

Первичное завершение (Действительный)

23 октября 2017 г.

Завершение исследования (Действительный)

19 апреля 2018 г.

Даты регистрации исследования

Первый отправленный

7 августа 2014 г.

Впервые представлено, что соответствует критериям контроля качества

7 августа 2014 г.

Первый опубликованный (Оценивать)

11 августа 2014 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

20 июня 2019 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

18 июня 2019 г.

Последняя проверка

1 июня 2019 г.

Дополнительная информация

Термины, связанные с этим исследованием

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

Да

Описание плана 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.

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

Клинические исследования PF-05280586

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