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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. Juni 2019 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

394

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: PF-05280586
Biologisch: PF-05280586
PF-05280586 (rituximab-Pfizer) concentrate for solution for infusion 375mg/m2 administered via IV infusion on Days 1, 8, 15, and 22
Aktiver Komparator: MabThera®
Biologisch: MabThera®
MabThera® (rituximab-EU) concentrate for solution for infusion 375mg/m2 administered via IV infusion on Days 1, 8, 15, and 22

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Overall Response Rate (ORR): Percentage of Participants With Overall Response (OR) at Week 26
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: Baseline up to Week 52
Immune-based adverse effects included infusion related reaction (IRR), adverse events which fulfill Sampson's criteria, and adverse events which belong to the Standardized Medical Dictionary for Regulatory Activities (MedDRA) Queries (SMQs) anaphylaxis or hypersensitivity reactions. Potential allergic and anaphylactic reactions were identified programmatically based on the criteria of Sampson et al, (2006).
Baseline up to Week 52

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Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

30. September 2014

Primärer Abschluss (Tatsächlich)

23. Oktober 2017

Studienabschluss (Tatsächlich)

19. April 2018

Studienanmeldedaten

Zuerst eingereicht

7. August 2014

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

7. August 2014

Zuerst gepostet (Schätzen)

11. August 2014

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

20. Juni 2019

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

18. Juni 2019

Zuletzt verifiziert

1. Juni 2019

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • B3281006
  • 2014-000132-41 (EudraCT-Nummer)
  • REFLECTIONS (Andere Kennung: Alias Study Number)

Plan für individuelle Teilnehmerdaten (IPD)

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Ja

Beschreibung des IPD-Plans

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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