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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 czerwca 2019 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

394

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: PF-05280586
Biologiczny: PF-05280586
PF-05280586 (rituximab-Pfizer) concentrate for solution for infusion 375mg/m2 administered via IV infusion on Days 1, 8, 15, and 22
Aktywny komparator: MabThera®
Biologiczny: MabThera®
MabThera® (rituximab-EU) concentrate for solution for infusion 375mg/m2 administered via IV infusion on Days 1, 8, 15, and 22

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Overall Response Rate (ORR): Percentage of Participants With Overall Response (OR) at Week 26
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

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Sponsor

Pfizer

Publikacje i pomocne linki

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Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

30 września 2014

Zakończenie podstawowe (Rzeczywisty)

23 października 2017

Ukończenie studiów (Rzeczywisty)

19 kwietnia 2018

Daty rejestracji na studia

Pierwszy przesłany

7 sierpnia 2014

Pierwszy przesłany, który spełnia kryteria kontroli jakości

7 sierpnia 2014

Pierwszy wysłany (Oszacować)

11 sierpnia 2014

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

20 czerwca 2019

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

18 czerwca 2019

Ostatnia weryfikacja

1 czerwca 2019

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • B3281006
  • 2014-000132-41 (Numer EudraCT)
  • REFLECTIONS (Inny identyfikator: Alias Study Number)

Plan dla danych uczestnika indywidualnego (IPD)

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Opis planu 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.

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