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. června 2019 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Aktuální)
394
Fáze
- Fáze 3
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Brussels, Belgie, 1070
- Hopital Erasme
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Brussels, Belgie, 1200
- Nuclear Medicine Department
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Charleroi, Belgie, 6000
- Grand Hopital de Charleroi-Site Notre-Dame
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Charleroi, Belgie, 6000
- PET/CT facility: Grand Hopital de Charleroi (GHdC) - site Notre-Dame
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Charleroi, Belgie, 6000
- Pharmacy Department: Grand Hopital de Charleroi (GHdC) - site Notre-Dame
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La Louviere (Haine-Saint Paul), Belgie, 7100
- Pharmacy Department, Centre Hospitalier De Jolimont - Lobbes
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La Louviere (Haine-Saint-Paul), Belgie, 7100
- Centre Hospitalier de Jolimont - Lobbes
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La Louviere (Haine-Saint-Paul), Belgie, 7100
- Radiology Department
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Mons, Belgie, 7000
- C.H.U. Ambroise Paré
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Mons, Belgie, 7000
- Pharmacy Department, CHU Ambroise Pare
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Sao Paulo, Brazílie, 01236-030
- IEP Sao Lucas - Instituto de Ensino e Pesquisa Sao Lucas / HEMOMED - Instituto de Oncologia e
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Sao Paulo, Brazílie, 01333-910
- Fleury
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Bahia
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Salvador, Bahia, Brazílie, 40050-410
- Hospital Santa Izabel - Setor de Bioimagem
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Salvador, Bahia, Brazílie, 40050-410
- Hospital Santa Izabel / Santa Casa de Misericordia da Bahia
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GO
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Goiania, GO, Brazílie, 74175-150
- Clinica Multimagem
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Goiania, GO, Brazílie, 74605-020
- Hospital das Clinicas da Universidade Federal de Goias \ Centro de Pesquisa Clinica
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MG
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Belo Horizonte, MG, Brazílie, 30130-100
- Centro de Imagens da Faculdade de Medicina - INCT Medicina Nuclear - PET/CT
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Belo Horizonte, MG, Brazílie, 30130-100
- Unidade Funcional Apoio Diagnostico e terapeutica por Imagem do HC/UFMG - CT Scan
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brazílie, 30130-100
- Hospital das Clinicas Universidade Federal de Minas Gerais
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RIO Grande DO SUL
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Porto Alegre, RIO Grande DO SUL, Brazílie, 90035-903
- Hospital de Clinicas de Porto Alegre
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Porto Alegre, RIO Grande DO SUL, Brazílie, 90035-903
- Central de Misturas Intravenosas do Hospital de Clinicas de Porto Alegre
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Porto Alegre, RIO Grande DO SUL, Brazílie, 90035-903
- Hospital de Clinicas de Porto Alegre - Centro de Pesquisa Clinica
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Porto Alegre, RIO Grande DO SUL, Brazílie, 90035-903
- Servico de Radiologia do Hospital de Clinicas de Porto Alegre
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RS
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Porto Alegre, RS, Brazílie, 90610-000
- CDI - Centro de Diagnostico por Imagem do Hospital Sao Lucas da PUCRS
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Porto Alegre, RS, Brazílie, 90610-000
- InsCer - Instituto do Cerebro do Rio Grande do Sul - PUCRS
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Porto Alegre, RS, Brazílie, 90610-000
- Uniao Brasileira de Educacao e Assistencia (UBEA) - Hospital Sao Lucas da PUCRS -
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SAO Paulo
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Jau, SAO Paulo, Brazílie, 17210-080
- Fundacao Amaral Carvalho / Fundacao Dr. Amaral Carvalho
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Jau, SAO Paulo, Brazílie, 17210-120
- Fundacao Amaral Carvalho / Fundacao Dr. Amaral Carvalho
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Jaú, SAO Paulo, Brazílie, 17210-120
- Unidade de Quimioterapia
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Santo Andre, SAO Paulo, Brazílie, 09030-340
- Casa da Esperanca
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Sao Bernardo do Campo, SAO Paulo, Brazílie, 09750-670
- TECNOLAB
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SP
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Campinas, SP, Brazílie, 13075-460
- CEMEDI
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Campinas, SP, Brazílie, 13075-460
- Instituto Radium
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Campinas, SP, Brazílie, 13087-567
- CAEP - Centro Avancado de Estudos e Pesquisas LTDA
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Campinas, SP, Brazílie, 13087-567
- Hospital e Maternidade Madre Theodora LTDA
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Campinas, SP, Brazílie, 13092-132
- CENNI Oncologia
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Santo Andre, SP, Brazílie, 09060-650
- Fundacao do ABC - FMABC/ Faculdade de Medicina ABC ( CEPHO - Centro de Estudos e Pesquisas de
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Sao Paulo, SP, Brazílie, 01506-000
- Hospital Bandeirantes
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Sao Paulo, SP, Brazílie, 05403-000
- Hospital das Clinicas da Faculdade de Medicina da USP / Fundacao Faculdade de Medicina MEC MPAS
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Sao Paulo, SP, Brazílie, 08270-070
- Casa de Saude Santa Marcelina (Centro de Pesquisa Santa Marcelina)
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São Paulo, SP, Brazílie, 01242-020
- IEP São Lucas (Pharmacy)
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Brest, Bělorusko, 224027
- Healthcare Institution "Brest Regional Oncologic Dispensary"
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Minsk, Bělorusko, 220013
- Healthcare Institution 'Minsk City Clinical Oncology Dispensary'
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Republic Of Belarus, Bělorusko, 223040
- SI Republican Research and Practice Centre of oncology and medical radiology n.a N.N Alexandrov
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Minsk Region
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Lesnoy, Minsk Region, Bělorusko, 220013
- SI 'Republican Research and Practice Centre of Oncology and Medical Radiology n.a. N.N. Alexandrov'
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Lesnoy, Minsk Region, Bělorusko, 223040
- SI 'Republican Research and Practice Centre of Oncology and Medical Radiology n.a. N.N. Alexandrov'
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Zagreb, Chorvatsko, 10000
- University Hospital Centre Zagreb
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Zagreb, Chorvatsko, 10 000
- University Hospital Center Zagreb, Department of Nuclear Medicine and Radiation Protection
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Zagreb, Chorvatsko, 10 000
- University Hospital Center Zagreb, Department of Pathology and Cytology
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Zagreb, Chorvatsko, 10 000
- University Hospital Center Zagreb, Department of Radiology
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Zagreb, Chorvatsko, 10000
- University Hospital Centre "Sestre Milosrdnice"
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Quezon City, Filipíny, 1102
- St. Luke's Medical Center
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Metro Manila
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Manila, Metro Manila, Filipíny, 1000
- University of Philippines Manila-Philippine General Hospital
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Boulogne Sur Mer, Francie, 62321
- Hopital Duchenne Chu - Boulogne Sur Mer
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Bourg En Bresse Cedex, Francie, 01012
- Centre Hospitalier de Bourg en Bresse
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Brest, Francie, 29609
- Hopital Morvan-CHU Brest- Service Hematologie Clinique
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Caen, Francie, 14033
- Centre Hospitalier Universitaire Côte de Nacre
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Le Mans, Francie, 72037
- Centre Hospitalier du Mans
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Lyon, Francie, 69009
- Clinique de la Sauvegarde
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Marseille Cedex 05
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Marseille, Marseille Cedex 05, Francie, 13385
- CHU Marseille Hopital de La Conception
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Mulhouse Cedex
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Mulhouse, Mulhouse Cedex, Francie, 68100
- CH de Mulhouse, Hopital Emile Muller
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NAP
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Boulogne Sur Mer, NAP, Francie, 62321
- Hopital Duchenne Chu - Boulogne Sur Mer
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Tbilisi, Gruzie, 0144
- High Technology Medical Center, University Clinic
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Tbilisi, Gruzie, 0112
- "LTD ""M. Zodelava's Hematology Centre"""
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Tbilisi, Gruzie, 0112
- LTD "Research Institute of Clinical Medicine"
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New Delhi, Indie, 110 085
- Rajiv Gandhi Cancer Institute & Research Center (RGCIRC)
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Gujarat
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Surat, Gujarat, Indie, 395001
- Super Scan Imaging Centre
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Surat, Gujarat, Indie, 395002
- Pathology Department, Unique Hospital Multispeciality & Research Institute
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Surat, Gujarat, Indie, 395002
- Zircon- BIC Imaging Centre
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Karanataka
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Mangalore, Karanataka, Indie, 575002
- Mangalore Institute of Oncology
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Karnataka
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Bangalore, Karnataka, Indie, 560027
- HealthCare Global Enterprises Limited
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Manipal, Karnataka, Indie, 576104
- Kasturba Medical College and Hospital
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Maharashtra
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Nashik, Maharashtra, Indie, 422004
- Curie Manavata Cancer Centre
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Nashik, Maharashtra, Indie, 422004
- Department of Radiology, Curie Manavata Cancer Centre
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Pune, Maharashtra, Indie, 411001
- Ruby Hall Clinic
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Pune, Maharashtra, Indie, 411001
- Department of Radiology
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Pune, Maharashtra, Indie, 411001
- Jehangir Clinical Development Centre Pvt. Ltd.
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Rajasthan
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Jaipur, Rajasthan, Indie, 302004
- R.K. Birla Cancer Center, Sawai Man Singh Hospital
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Tamilnadu
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Chennai, Tamilnadu, Indie, 600035
- Apollo Speciality Hospital
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Chennai, Tamilnadu, Indie, 600035
- Department of Radiology
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Telangana
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Hyderabad, Telangana, Indie, 500 004
- Global Hospitals
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Hyderabad, Telangana, Indie, 500029
- Vijaya Diagnostic Centre
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WEST Bengal
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Kolkata, WEST Bengal, Indie, 700014
- N.R.S Medical College and Hospital
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Kolkata, WEST Bengal, Indie, 700014
- Spandan PET-CT Unit
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Genova, Itálie, 16132
- IRCSS A.O.U. San Martino - IST - UO Clinica Ematologica
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Milano, Itálie, 20133
- SC Ematologia, Fondazione IRCCS Ist Nazionale dei Tumori
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Parma, Itálie, 43100
- Padiglione 1, Torre delle medicine, 6 piano
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Pesaro, Itálie, 61122
- Ematologia e Centro Trapianti - AZ Osp. Ospedali Riuniti Marche Nord (AORMN) - Presidio S. Salvatore
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Pisa, Itálie, 56126
- U.O. Ematologia Universitaria - Dip. Di Oncologia dei Trapianti - AOU Pisana
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Roma, Itálie, 00128
- Policlinico Universitario Campus Bio- Medico-U.O.C. di Ematologia Trapianto Cellule Staminali
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CR
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Cremona, CR, Itálie, 26100
- U.O. di Ematologia e CTMO - Istituti Ospedalieri di Cremona
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FC
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Meldola, FC, Itálie, 47014
- IRST - IRCCS U. O. Oncologia Medica
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GE
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Genova, GE, Itálie, 16132
- U.O. Ematologia 1 - IRCCS AOU San Martino-IST
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MB
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Monza, MB, Itálie, 20900
- Unita di Ricerca Clinica
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MI
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Milano, MI, Itálie, 20141
- Istituto Europeo di Oncologia
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NAP
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Latina, NAP, Itálie, 04100
- Unità semplice di Medicina Nucleare
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PG
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Terni, PG, Itálie, 05100
- Az Ospedaliera Santa Maria
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Palermo
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Torrette Ancona, Palermo, Itálie, 60121
- Clinica Ematologica - A.O.U. Ospedali Riuniti di Ancona
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Reggio
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Reggio Emilia, Reggio, Itálie, 42123
- Medicina nucleare
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Reggio Emilia, Reggio, Itálie, 42123
- Radiologia
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Reggio Emilia, Reggio, Itálie, 42123
- SC Ematologia - SC Ematologia - Arcispedale Santa Maria Nuova - IRCCS
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Rome Rm
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Rome, Rome Rm, Itálie, 00161
- "Dipartimento di Biotecnologie Cellulari ed Ematologia, Universita ""Sapienza""
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Fukuoka, Japonsko, 811-0213
- Fukuoka Wajiro PET Diagnostic Imaging Clinic
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Nagano, Japonsko, 399-8701
- National Hospital Organization Matsumoto Medical Center
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Tokyo, Japonsko, 2080022
- Musashimurayama Hospital
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Aichi
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Nagoya, Aichi, Japonsko, 466-8650
- Nagoya Daini Red Cross Hospital
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Nagoya, Aichi, Japonsko, 464-0044
- East Nagoya Imaging Diagnosis Center
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Akita
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Akita City, Akita, Japonsko, 010-8543
- Akita University Hospital
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Chiba
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Chiba-shi, Chiba, Japonsko, 260-8717
- Chiba Cancer Center
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Fukuoka
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Fukuoka-Shi, Fukuoka, Japonsko, 811-1395
- National Hospital Organization Kyushu Cancer Center
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Fukuoka-shi, Fukuoka, Japonsko, 810-8563
- National Hospital Organization Kyushu Medical Center
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Hyogo
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Kobe-City, Hyogo, Japonsko, 650-0047
- Kobe City Medical Center General Hospital
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Ishikawa
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Kanazawa, Ishikawa, Japonsko, 920-8650
- National Hospital Organization Kanazawa Medical Center
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Kanazawa, Ishikawa, Japonsko, 9200934
- Kanazawa Advanced Medical Center
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Kanagawa-ken
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Yokohama-shi, Kanagawa-ken, Japonsko, 224-8503
- Showa University Northern Yokohama Hospital
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Kochi
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Okocho, Nankoku, Kochi, Japonsko, 783-8505
- Kochi Medical School Hospital
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Kumamoto-ken
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Kumamoto-shi, Kumamoto-ken, Japonsko, 860-0008
- National Hospital Organization Kumamoto Medical Center
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Kumamoto-shi, Kumamoto-ken, Japonsko, 862-0941
- Uozumi Clinic
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Miyagi
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Sendai-shi, Miyagi, Japonsko, 983-8520
- National Hospital Organization Sendai Medical Center
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Sendai-shi, Miyagi, Japonsko, 980-0873
- Sendai Kousei Hospital
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Nagano
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Matsumoto-shi, Nagano, Japonsko, 390-8510
- Aizawa Hospital
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Nagano-shi, Nagano, Japonsko, 380-8582
- Nagano Red Cross Hospital
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Nagasaki
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Omura, Nagasaki, Japonsko, 856-8562
- National Hospital Organization Nagasaki Medical Center
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Osaka
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Kawachinagano, Osaka, Japonsko, 586-8521
- National Hospital Organization Osaka Minami Medical Center
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Naka-ku Sakai, Osaka, Japonsko, 599-8271
- Hanwa Dai 2 Senboku Hospital
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Osaka-City, Osaka, Japonsko, 545-8586
- Osaka City University Hospital
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Tokushima
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Tokushima-Shi, Tokushima, Japonsko, 770-8503
- Tokushima University Hospital
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Tokyo
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Meguro-Ku, Tokyo, Japonsko, 152-8902
- National Hospital Organization Tokyo Medical Center
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Shinagawa-ku, Tokyo, Japonsko, 142-8666
- Showa University Hospital
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Tachikawa, Tokyo, Japonsko, 190-0014
- National Hospital Organization Disaster Medical Center
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Yamagata
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Yamagata-Shi, Yamagata, Japonsko, 990-9585
- Yamagata University Hospital
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Gauteng
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Groenkloof, Gauteng, Jižní Afrika, 0181
- NIKSCH & PARTNERS t/a CAPITAL RADIOLOGY
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Johannesburg, Gauteng, Jižní Afrika, 2196
- The Medical Oncology Centre of Rosebank
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Pretoria, Gauteng, Jižní Afrika, 0002
- Department of Medical Oncology, University of Pretoria, Steve Biko Academic Hospitals Complex
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Pretoria, Gauteng, Jižní Afrika, 0044
- Albert Alberts Stem Cell Transplant Centre
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Pretoria, Gauteng, Jižní Afrika, 0044
- Dr JN De Jong and Partners t/a East Rad
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Pretoria, Gauteng, Jižní Afrika, 0181
- NIKSCH & PARTNERS t/a CAPITAL RADIOLOGY
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Rosebank, Gauteng, Jižní Afrika, 2196
- Drs Sulman & Partners Specialist Radiologists
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Sandton, Gauteng, Jižní Afrika, 2191
- Drs Bloch & Partners Incorporated
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Busan, Korejská republika, 47392
- Inje University Busan Paik Hospital
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Seoul, Korejská republika, 03080
- Seoul National University Hospital
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Seoul, Korejská republika, 06351
- Samsung Medical Center
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Gyeonggi-do
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Anyang-si, Gyeonggi-do, Korejská republika, 14068
- Hallym University Sacred Heart Hospital
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Seongnam-si, Gyeonggi-do, Korejská republika, 463-707
- Seoul National University Bundang Hospital
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Jeollabuk-do
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Jeonju-si, Jeollabuk-do, Korejská republika, 54907
- Chonbuk National University Hospital
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Korea
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Ulsan, Korea, Korejská republika, 44033
- Ulsan University Hospital
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Ankara, Krocan, 06100
- Hacettepe Universitesi Tip Fakultesi Onkoloji Hastanesi
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Ankara, Krocan, 06200
- Dr. Abdurrahman Yurtaslan Ankara Onkoloji Eg. ve Aras.
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Ankara, Krocan, 06420
- Ultramar Tibbi Gorunteleme Merkezi
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Ankara, Krocan, 06420
- Ultramar Tibbi Goruntuleme Merkezi
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Ankara, Krocan, 06540
- Integra Gurses Teshis Tedavi ve Saglik Hizmetleri A.S.
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Aydin, Krocan, 09010
- Adnan Menderes University Medical Faculty
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Gaziantep, Krocan, 27310
- Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi
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Gaziantep, Krocan, 27310
- Gaziantep Universitesi Sahinbey Arastirma ve Uygulama
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Istanbul, Krocan, 34093
- Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
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Izmir, Krocan, 35040
- Ege Universitesi Tip Fakultesi Ic Hastaliklari Anabilim Dali
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Izmir, Krocan, 35040
- EGE-RAD Bilgisayarli Tomografi Ozel Saglik Hizmetleri ve Malzemeleri Tic.Ltd.Sti.
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Kayseri, Krocan, 38100
- Erciyes Universitesi Tip Fakultesi Nukleer Tip Laboratuvari
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Kayseri, Krocan, 38100
- Erciyes Universitesi Tip Fakultesi Radyoloji Laboratuvari
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Kayseri, Krocan, 38100
- Erciyes Universitesi Tip Fakultesi
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Malatya, Krocan, 44280
- Inonu Universitesi Tip Fakultesi Turgut Ozal Tip Merkezi
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Manisa, Krocan, 45000
- Celal Bayar University Medical Faculty
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Samsun, Krocan, 55139
- Ondokuz Mayis Universitesi Tip Fakultesi
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Beirut, Libanon
- Doctors Center Radiology
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Beirut, Libanon
- Mount Lebanon Hospital
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El Metn, Libanon
- Middle East Institute Of Health
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Mount Lebanon, Libanon
- Ain Wazein Hospital
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Southern Governate
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Saida, Southern Governate, Libanon
- Hammoud Hospital, University Medical Center
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Oaxaca, Mexiko, 68000
- Oaxaca Site Management Organization S.C.
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Oaxaca, Mexiko, 68000
- Cirurgia y Ginecobstetricia de Oaxaca, S.A de C.V.
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Puebla, Mexiko, 72190
- Hospital Angeles Puebla
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Queretaro, Mexiko, 76090
- Cancerologia de Queretaro S.C.
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Queretaro, Mexiko, 76140
- Hospital Infantil Teleton de Oncologia
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Queretaro, Mexiko, 76158
- Hospital San Jose Norte
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Distrito Federal
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Mexico City, Distrito Federal, Mexiko, 03310
- Grupo Médico Camino S.C.
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Mexico City, Distrito Federal, Mexiko, 03340
- Imagenus
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Mexico City, Distrito Federal, Mexiko, 06700
- Isos Pharmacorp, S.A. de C.V.
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Estado DE Mexico
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Cuautitlan Izacalli, Estado DE Mexico, Mexiko, 54750
- Vely Grupo Medico Quirurgico, S.A. de C.V.
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Cuautitlan Izcalli, Estado DE Mexico, Mexiko, 54769
- Phylasis Clinicas Research S. de R.L. de C.V.
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Nuevo LEON
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Monterrey, Nuevo LEON, Mexiko, 64460
- Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
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Monterrey, Nuevo LEON, Mexiko, 64460
- Centro Universitario de Imagen Diagnostica, Radiologia e Imagen del Hospital Universitario
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Berlin, Německo, 13353
- Charité - Universitätsmedizin Berlin
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Berlin, Německo, 12200
- Charite - Universitaetsmedizin Berlin
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Berlin, Německo, 12200
- Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin
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Berlin, Německo, 13353
- Charite - Universitaetsmedizin Berlin, Campus Virchow-Klinikum
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Berlin, Německo, 13353
- Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum
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Chemnitz, Německo, 09113
- Klinikum Chemnitz gGmbH
-
Chemnitz, Německo, 09113
- Klinikum Chemnitz gGmbH - Institut fuer Interventionelle Radiologie und Neuroradiologie
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Chemnitz, Německo, 09116
- Klinikum Chemnitz gGmbH - Klinik fuer Nuklearmedizin
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Chemnitz, Německo, 09116
- Klinikum Chemnitz gGmbH - Zentralapotheke
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Essen, Německo, 45147
- Universitaetsklinikum Essen (AoeR)
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Essen, Německo, 45147
- Universitatsklinikum Essen (Aor)
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Herne, Německo, 44623
- DokuSan Gesellschaft fuer Medizinische Studien mbH & Co. KG
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Herne, Německo, 44649
- Apotheke des St. Anna Hospital
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Herne, Německo, 44651
- EVK Eickel
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Koeln, Německo, 50679
- Praxis im Koeln Triangle
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Mutlangen, Německo, 73557
- Gemeinschaftspraxis fuer Diagnostische Radiologie und Nuklearmedizin
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Mutlangen, Německo, 73557
- Kliniken Ostalb, Stauferklinikum Schwaebisch Gmuend, Zentrum fuer Innere Medizin
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Mutlangen, Německo, 73557
- Stauferklinikum Schwaebisch Gmuend, Apotheke
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Rostock, Německo, 18057
- Universitaetsmedizin Rostock
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Stuttgart, Německo, 70174
- Klinikum Stuttgart, Klinik fuer Nuklearmedizin
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Stuttgart, Německo, 70199
- Vinzenz von Paul Kliniken GgmbH
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Troisdorf, Německo, 53840
- Radiologie Rhein-Sieg
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Troisdorf, Německo, 53840
- Ueberoertliche Berufsausuebungsgemeinschaft Drs. med. Helmut Forstbauer
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Troisdorf, Německo, 53842
- Zentralapotheke
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Lima, Peru, 18
- Pet Scan Peru
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Lima, Peru, 18
- Resocentro
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Lima
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Surquillo, Lima, Peru, 34
- Instituto Nacional de Enfermedades Neoplasicas
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-
Warszawa, Polsko, 02-781
- Klinika Nowotworow Ukladu Chlonnego Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie
-
Wroclaw, Polsko, 50-420
- Euromedic Wroclawskie Centrum Medyczne II
-
Wroclaw, Polsko, 50-557
- Euromedic Wroclawskie Centrum Medyczne III
-
Wroclaw, Polsko, 53-439
- Dolnośląskie Centrum Transplantacji Komórkowych z Krajowym Bankiem Dawców Szpiku
-
Wroclaw, Polsko, 53-439
- Euromedic Wroclawskie Centrum Medyczne I
-
Wroclaw, Polsko, 54-424
- Apteka Dolnoslaskiego Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku
-
-
-
-
-
Coto Laurel, Portoriko, 00780
- Modern Radiology, PSC
-
Ponce, Portoriko, 00717
- Ad-Vance Medical Research, LLC
-
Ponce, Portoriko, 00717
- Caribe MRI and CT
-
-
-
-
-
Braga, Portugalsko, 4710-243
- Hospital de Braga
-
Lisboa, Portugalsko, 1998-018
- Hospital CUF Descobertas
-
Porto, Portugalsko, 4050-075
- CIMC
-
Porto, Portugalsko, 4050-075
- Dr. Campos Costa Clinic
-
Porto, Portugalsko, 4099 - 001
- Centro Hospitalar do Porto-Hospital de Santo Antonio E.P.E.
-
Porto, Portugalsko, 4200-072
- Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E
-
Vila Nova de Gaia, Portugalsko, 4434-502
- Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
-
-
Porto
-
Matosinhos, Porto, Portugalsko, 4464-513
- Unidade Local de Saude de Matosinhos E.P.E. - Hospital Pedro Hispano S.A.
-
-
-
-
-
Linz, Rakousko, 4010
- Krankenhaus Der Barmherzigen Schwestern Linz
-
Linz, Rakousko, 4020
- Kepler Universitaetsklinikum GmbH
-
Linz, Rakousko, 4021
- Kepler Universitaetsklinikum GmbH
-
-
-
-
-
Brasov, Rumunsko, 500152
- Policlinica de Diagnostic Rapid, Hematologie
-
Brasov, Rumunsko, 500366
- Policlinica de Diagnostic Rapid SA
-
Bucuresti, Rumunsko, 030171
- Spitalul Clinic Coltea, Clinica de Hematologie
-
Bucuresti, Rumunsko, 020125
- Spitalul Clinic Colentina
-
Bucuresti, Rumunsko, 021675
- Hiperdia Ritmului
-
Bucuresti, Rumunsko, 022328
- Affidea Fundeni
-
Bucuresti, Rumunsko, 022328
- Affidea Romania SRL
-
Cluj-Napoca, Rumunsko, 400015
- Institutul Oncologic Prof. Dr. Ion Chiricuta, Laborator Radiologie si Imagistica Medicala
-
Cluj-Napoca, Rumunsko, 400015
- Institutul Oncologic Prof. Dr. Ion Chiricuta, Sectia Oncologie Medicala
-
Cluj-Napoca, Rumunsko, 400124
- Clinica de Hematologie-Institutul Oncologic, Prof. Dr. Ion Chiricuta
-
Cluj-Napoca, Rumunsko, 400489
- CT Clinic S.R.L.
-
-
-
-
-
Chelyabinsk, Ruská Federace, 454087
- "State Budget Healthcare Institution ""Chelyabinsk Regional Clinical Center of Oncology
-
Moscow, Ruská Federace, 121309
- LLC "Vitamed"
-
Moscow, Ruská Federace, 115478
- FSBSI 'N.N.Blokhin Russian Cancer Research Center' of MoH of RF
-
Moscow, Ruská Federace, 115478
- Russian Cancer Research Centre them N.N. Blokhin
-
Moscow, Ruská Federace, 125284
- SBHI of Moscow City Clinical Hospital n.a. S.P.Botkin of Healthcare Department of Moscow
-
Moscow, Ruská Federace, 127473
- Ramsay Diagnostics
-
Saint Petersburg, Ruská Federace, 194291
- State Budgetary Institution of Healthcare "Leningrad Regional Clinical Hospital"
-
Saint-Petersburg, Ruská Federace, 194214
- Dr. Berezin Medical Institute
-
Saint-Petersburg, Ruská Federace, 197376
- N.P. Bechtereva Institute of Human Brain of the Russian Academy of Sciences
-
Saint-Petersburg, Ruská Federace, 197376
- N.P. Bechtereva Institute of the Human Brain of the Russian Academy of Sciences
-
Saint-Petersurg, Ruská Federace, 195271
- Non-state healthcare institution "Road Clinical Hospital of Joint Stock Company "Russian Railways"
-
Yaroslavl, Ruská Federace, 150010
- Yaroslavl State Medical Academy
-
Yaroslavl, Ruská Federace, 150062
- GBUZ of Yaroslavl Region "Regional Clinical Hospital"
-
-
Kaluga Region
-
Obninsk, Kaluga Region, Ruská Federace, 249036
- A.Tsyb Medical Radiological Research Centre -
-
-
Mordovian Republic
-
Saransk, Mordovian Republic, Ruská Federace, 430032
- State Healthcare Institution Republican Oncology Dispensary
-
-
Nizhniy Novgorod Region
-
Nizhniy Novgorod, Nizhniy Novgorod Region, Ruská Federace, 603126
- "SBHI of NNR ""Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko"""
-
Nizhniy Novgorod, Nizhniy Novgorod Region, Ruská Federace, 603126
- LLC MC "MRT-Diagnostika"
-
-
Pesochniy
-
Saint-Petersburg, Pesochniy, Ruská Federace, 197758
- FSBI "Russian Research Centre of Radiology and Surgical Technologies n.a. A.M. Granov" of MoH of RF
-
Saint-Petersburg, Pesochniy, Ruská Federace, 197758
- FSBI "Russian Research Centre of Radiology and Surgical Technologies named after academician
-
Saint-Petersburg, Pesochniy, Ruská Federace, 197758
- FSBI "Russian Research Centre of Radiology and Surgical Technologies
-
-
Pesochniy TOWN
-
Saint-Petersburg, Pesochniy TOWN, Ruská Federace, 197758
- FSBI "Russian Research Centre of Radiology and Surgical Technologies" of MoH of RF
-
Saint-Petersburg, Pesochniy TOWN, Ruská Federace, 197758
- FSBI "Russian Research Centre of Radiology and Surgical Technologies"
-
Saint-Petersburg, Pesochniy TOWN, Ruská Federace, 197758
- FSBI "Russian Research Centre of Radiology and Surgical Technologies
-
Saint-Petersburg, Pesochniy TOWN, Ruská Federace, 197758
- FSBI 'Russian Research Centre of Radiology and Surgical Technologies
-
-
Pos.pesochny
-
Saint-Petersburg, Pos.pesochny, Ruská Federace, 197758
- FSBI 'National Medical Oncology Research Centre n.a. N.N.Petrov'
-
-
Republic Bashkortostan
-
Ufa, Republic Bashkortostan, Ruská Federace, 450054
- Branch office of LLC 'PET-Technology' at Ufa city
-
Ufa, Republic Bashkortostan, Ruská Federace, 450054
- State Budgetary Healthcare Institution "Republican Clinical Oncology Dispensary of the Ministry
-
-
Saint Petersburg
-
Pushkin, Saint Petersburg, Ruská Federace, 196603
- Private Medical Institution "Euromedservice"
-
-
Saint-petersburg
-
Pesochniy Town, Saint-petersburg, Ruská Federace, 197758
- FSBI "Russian Research Centre of Radiology and Surgical Technologies" of MoH of RF
-
-
Stavropol Region
-
Lermontov, Stavropol Region, Ruská Federace, 357340
- Federal State-Financed Institution 'North-Caucasian Research and Clinical Center'
-
Pyatigorsk, Stavropol Region, Ruská Federace, 357502
- SBHI of Stavropol Region "Pyatigorsk Interdistrict Oncology Dispensary
-
-
-
-
-
Bath, Spojené království, BA1 3NG
- Royal United Hospitals Bath NHS Foundation Trust
-
London, Spojené království, EC1A 7BE
- Barts Health NHS Trust
-
Newcastle upon Tyne, Spojené království, NE4 6BE
- Positron Emission Tomography (PET) Centre
-
Sunderland, Spojené království, SR4 7TP
- City Hospitals Sunderland NHS Foundation Trust-Sunderland Royal Hospital
-
Sunderland, Spojené království, SR4 7TP
- Diagnostic Imaging
-
-
Essex
-
Westcliff-On-Sea, Essex, Spojené království, SS0 0RY
- Southend University Hospital NHS Foundation Trust
-
-
Glos.
-
Cheltenham, Glos., Spojené království, GL53 7AS
- Cobalt Diagnostic Imaging
-
-
-
-
California
-
Anaheim, California, Spojené státy, 92801
- Pacific Cancer Medical Center, Inc.
-
Anaheim, California, Spojené státy, 92801
- The Oncology Institute of Hope and Innovation
-
Corona, California, Spojené státy, 92879
- Compassionate Care Research Group, Inc., at Compassionate Cancer Care Medical Group, Inc.
-
Downey, California, Spojené státy, 90241
- The Oncology Institute of Hope and Innovation
-
Fountain Valley, California, Spojené státy, 92708
- Compassionate Care Research Group, Inc., at Compassionate Cancer Care Medical Group, Inc.
-
Gilroy, California, Spojené státy, 95020
- Global Cancer Research Institute (GCRI), Inc
-
Gilroy, California, Spojené státy, 95020
- Saint Louise Regional Hospital Radiology Department (Radiology Only)
-
Gilroy, California, Spojené státy, 95020
- South Valley Imaging Center (Imaging Only)
-
Glendale, California, Spojené státy, 91204
- Los Angeles Hematology Oncology Medical Group
-
Glendale, California, Spojené státy, 91204
- The Oncology Institute of Hope and Innovation
-
Glendale, California, Spojené státy, 91206
- Los Angeles Hematology Oncology Medical Group
-
Long Beach, California, Spojené státy, 90805
- The Oncology Institute of Hope and Innovation
-
Los Angeles, California, Spojené státy, 90017
- Los Angeles Hematology Oncology Medical Group
-
Los Angeles, California, Spojené státy, 90057
- Los Angeles Hematology Oncology Medical Group
-
Lynwood, California, Spojené státy, 90262
- The Oncology Institute of Hope and Innovation
-
Montebello, California, Spojené státy, 90640
- The Oncology Institute of Hope and Innovation
-
Palm Springs, California, Spojené státy, 92262
- Comprehensive Cancer Center at Desert Regional Medical Center
-
Redondo Beach, California, Spojené státy, 90277
- Torrance Health Association DBA, Torrance Memorial Physician, Network/Cancer Care Associates
-
Riverside, California, Spojené státy, 92501
- Compassionate Care Research Group, Inc., at Compassionate Cancer Care Medical Group, Inc.
-
San Jose, California, Spojené státy, 95128
- O'Connor Hospital
-
San Jose, California, Spojené státy, 95124
- Global Cancer Research Institute, Inc.
-
San Jose, California, Spojené státy, 95128
- PET Imaging of San Jose (Imaging Only)
-
Santa Ana, California, Spojené státy, 92705
- The Oncology Institute of Hope and Innovation
-
Torrance, California, Spojené státy, 90505
- Torrance Memorial Medical Center
-
Whittier, California, Spojené státy, 90603
- Innovative Clinical Research Institute (ICRI)
-
Whittier, California, Spojené státy, 90602
- The Oncology Institute of Hope and Innovation
-
-
Colorado
-
Aurora, Colorado, Spojené státy, 80012
- Rocky Mountain Cancer Centers
-
Boulder, Colorado, Spojené státy, 80303
- Rocky Mountain Cancer Centers
-
Denver, Colorado, Spojené státy, 80218
- Rocky Mountain Cancer Centers
-
Lakewood, Colorado, Spojené státy, 80228
- Rocky Mountain Cancer Center-Lakewood (Laboratory)
-
Lakewood, Colorado, Spojené státy, 80228
- Rocky Mountain Cancer Centers (RMCC) - Lakewood - St Anthony
-
Lone Tree, Colorado, Spojené státy, 80124
- Rocky Mountain Cancer Centers
-
Pueblo, Colorado, Spojené státy, 81008
- Rocky Mountain Cancer Center Pueblo
-
-
Georgia
-
Thomasville, Georgia, Spojené státy, 31792
- John D. Archbold Memorial Hospital
-
Thomasville, Georgia, Spojené státy, 31792
- Lewis Hall Singletary Oncology Center at John D. Archbold Memorial Hospital
-
-
Illinois
-
DeKalb, Illinois, Spojené státy, 60115
- Northwestern Medicine West Region
-
Geneva, Illinois, Spojené státy, 60134
- Cancer Center,Northwestern Medicine, West Region
-
-
Kansas
-
Chanute, Kansas, Spojené státy, 66720
- Cancer Center of Kansas
-
Dodge City, Kansas, Spojené státy, 67801
- Cancer Center of Kansas
-
El Dorado, Kansas, Spojené státy, 67042
- Cancer Center of Kansas
-
Independence, Kansas, Spojené státy, 67301
- Cancer Center of Kansas
-
Kingman, Kansas, Spojené státy, 67068
- Cancer Center of Kansas
-
Liberal, Kansas, Spojené státy, 67905
- Cancer Center of Kansas
-
McPherson, Kansas, Spojené státy, 67460
- Cancer Center of Kansas
-
Newton, Kansas, Spojené státy, 67114
- Cancer Center of Kansas
-
Overland Park, Kansas, Spojené státy, 66210
- The University of Kansas Cancer Center
-
Parsons, Kansas, Spojené státy, 67357
- Cancer Center of Kansas
-
Salina, Kansas, Spojené státy, 67401
- Cancer Center of Kansas
-
Wellington, Kansas, Spojené státy, 67152
- Cancer Center of Kansas
-
Wichita, Kansas, Spojené státy, 67214
- Cancer Center of Kansas
-
Wichita, Kansas, Spojené státy, 67208
- Cancer Center of Kansas
-
Winfield, Kansas, Spojené státy, 67156
- Cancer Center of Kansas
-
-
Maryland
-
Baltimore, Maryland, Spojené státy, 21229
- Saint Agnes Hospital
-
Baltimore, Maryland, Spojené státy, 21229
- PET/CT facility Seton Imaging Center
-
Bethesda, Maryland, Spojené státy, 20817
- Rcca Md Llc
-
Silver Spring, Maryland, Spojené státy, 20910
- Holy Cross Hospital
-
Silver Spring, Maryland, Spojené státy, 20902
- Holy Cross Hospital Resource Center
-
Silver Spring, Maryland, Spojené státy, 20910
- Holy Cross Hospital Hospital Pharmacy
-
Wheaton, Maryland, Spojené státy, 20902
- Maryland Oncology Hematology, P.A.
-
-
Missouri
-
Kansas City, Missouri, Spojené státy, 64131
- The University of Kansas Cancer Center
-
Kansas City, Missouri, Spojené státy, 64154
- The University of Kansas Cancer Center
-
Lee's Summit, Missouri, Spojené státy, 64064
- The University of Kansas Cancer Center
-
-
Nebraska
-
Grand Island, Nebraska, Spojené státy, 68803
- Saint Francis Medical Center, Saint Francis Cancer Treatment Center
-
Grand Island, Nebraska, Spojené státy, 68803
- Saint Francis Medical Center
-
Hastings, Nebraska, Spojené státy, 68901
- Saint Francis Medical Center, Saint Francis Cancer Treatment Center
-
-
Nevada
-
Henderson, Nevada, Spojené státy, 89074
- Comprehensive Cancer Centers of Nevada
-
Henderson, Nevada, Spojené státy, 89052
- Comprehensive Cancer Centers of Nevada
-
Las Vegas, Nevada, Spojené státy, 89148
- Comprehensive Cancer Centers of Nevada
-
Las Vegas, Nevada, Spojené státy, 89128
- Comprehensive Cancer Centers of Nevada
-
Las Vegas, Nevada, Spojené státy, 89169
- Comprehensive Cancer Centers of Nevada
-
-
North Carolina
-
Greenville, North Carolina, Spojené státy, 27834
- Vidant Medical Center
-
Greenville, North Carolina, Spojené státy, 27834
- Brody School of Medicine at East Carolina University
-
Greenville, North Carolina, Spojené státy, 27834
- Vidant Medical Center Pharmacy
-
-
Ohio
-
Maumee, Ohio, Spojené státy, 43537
- Toledo Clinic Cancer Center - Maumee
-
Toledo, Ohio, Spojené státy, 43623
- Toledo Clinic Cancer Center - Toledo
-
Toledo, Ohio, Spojené státy, 43623
- Toledo Clinic, Inc.
-
-
Oregon
-
Eugene, Oregon, Spojené státy, 97401
- Willamette Valley Cancer Institute and Research Center
-
-
Tennessee
-
Knoxville, Tennessee, Spojené státy, 37920
- University of Tennessee Medical Center
-
-
Texas
-
Fort Sam Houston, Texas, Spojené státy, 78234
- San Antonio Military Medical Center
-
Fort Sam Houston, Texas, Spojené státy, 78234
- San Antonio Military Medical Center- Department of Pharmacy
-
Fort Sam Houston, Texas, Spojené státy, 78234
- San Antonio Military Medical Center- Department of Radiology
-
Fort Worth, Texas, Spojené státy, 76177
- Investigational Products Center (IPC)
-
Fort Worth, Texas, Spojené státy, 76177
- Investigational Products Center (I PC)
-
Houston, Texas, Spojené státy, 77090
- Millennium Oncology
-
Irving, Texas, Spojené státy, 75063
- US Oncology Investigational Products Center (IPC)
-
Kingwood, Texas, Spojené státy, 77339
- Millennium Oncology
-
Longview, Texas, Spojené státy, 75601
- Texas Oncology - Longview Cancer Center
-
Shenandoah, Texas, Spojené státy, 77384
- Millennium Oncology
-
The Woodlands, Texas, Spojené státy, 77380
- Millennium Oncology
-
Tyler, Texas, Spojené státy, 75702
- Texas Oncology-Tyler
-
-
Washington
-
Yakima, Washington, Spojené státy, 98902
- Yakima Valley Memorial Hospital/North Star Lodge Cancer Center
-
-
-
-
-
Bangkok, Thajsko, 10400
- National Cancer Institute
-
Bangkok, Thajsko, 10400
- Cardiology Unit,Department of Medicine, Faculty of Medicine, Ramathibodi Hospital,
-
Bangkok, Thajsko, 10400
- Department of Radiology, Ramathibodi Hospital
-
-
-
-
-
Chernivtsi, Ukrajina, 58013
- "Municipal Institution ""Chernivtsi Regional Clinical Oncology Center"",
-
Dnipropetrovsk, Ukrajina, 49102
- MI 'City Dnipropetrovsk Multi-field Clin. Hospital #4 of DRC',
-
Kharkiv, Ukrajina, 61070
- Municipal Non-Profit Enterprise "Regional Oncology Centre"
-
Kyiv, Ukrajina, 03022
- National Cancer Institute
-
Uzhhorod, Ukrajina, 88017
- "Central City Clinical Hospital, City Oncology Center, SHEI ""Uzhhorod National University"", Chair
-
Vinnytsia, Ukrajina, 21029
- Podilskyy Regional Oncology Center, Chemotherapy Department
-
Zaporizhzhia, Ukrajina, 69040
- Municipal Establishment 'Zaporizhzhia Regional Clinical Oncology Dispensary'
-
Zaporizhzhia, Ukrajina, 69076
- LLC "Diaservis"
-
-
KYIV Region
-
Obukhiv, KYIV Region, Ukrajina, 08720
- "MedX-Ray International Group" LLC
-
Obukhiv District, KYIV Region, Ukrajina, 08720
- "Mediks-rey International Group" LLC
-
Obukhiv District, KYIV Region, Ukrajina, 08720
- "MedX-rey International Group" LLC
-
-
-
-
-
Athens, Řecko, 10676
- Gen. Hosp. of Athens "Evangelismos - Eye Hosp.- Polikliniki"
-
Athens, Řecko, 10676
- Gen. Hosp. of Athens "Evangelismos-Eye Hosp. - Polikliniki"
-
Athens, Řecko, 10676
- Gen. Hosp. of Athens "Evangelismos-Eye Hosp.-Polikliniki"
-
Athens, Řecko, 10676
- Gen.Hosp.of Athens "Evangelismos-Eye Hosp.-polikiliniki"
-
Athens, Řecko, 10676
- General Hospital of Athens "Evangelismos - Eye Hosp. - Polikliniki"
-
Athens, Řecko, 11526
- Bioiatriki S.A.
-
Athens, Řecko, 11526
- Bioiatriki
-
Athens, Řecko, 11527
- General Hospital of Athens 'Laiko'
-
Athens, Řecko, 12462
- """ATTIKON"" Gen. Univ. Hosp"
-
Chaidari, Athens, Řecko, 12462
- "ATTIKON'' Gen. Univ. Hosp.
-
Patras, Řecko, 26504
- University General Hospital of Patras
-
Patras, Řecko, 26222
- Magnitiki Patron
-
-
-
-
-
A Coruna, Španělsko, 15006
- Complejo Hospitalario Universitario A Coruña
-
A Coruna, Španělsko, 15011
- Hospital Modelo
-
Barcelona, Španělsko, 08003
- Hospital Del Mar
-
Barcelona, Španělsko, 08012
- Hospital Quiron de Barcelona, IEC
-
Barcelona, Španělsko, 08029
- CETIR, Centre Medic
-
Barcelona, Španělsko, 08029
- Radiodiagnostic CETIR - Clinica del Pilar
-
Cadiz, Španělsko, 11009
- Hospital Universitario Puerta del Mar
-
Madrid, Španělsko, 28040
- Hospital Universitario Fundación Jiménez Díaz
-
Madrid, Španělsko, 28050
- Hospital Universitario Sanitas La Moraleja
-
Malaga, Španělsko, 29010
- Hospital Universitario Virgen de la Victoria
-
Malaga, Španělsko, 29010
- Centro CIMES
-
Malaga, Španělsko, 29016
- Centro Mario Gallegos
-
Ourense, Španělsko, 32005
- Complejo Hospitalario de Ourense. Hematología
-
Sevilla, Španělsko, 41013
- Hospital Universitario Virgen del Rocío
-
Zaragoza, Španělsko, 50012
- Hospital de Dia Quiron Zaragoza
-
Zaragoza, Španělsko, 50006
- H. Quirón Zaragoza
-
-
Barcelona
-
Sabadell, Barcelona, Španělsko, 08208
- Hospital Parc Tauli
-
-
Guipuzcoa
-
San Sebastian, Guipuzcoa, Španělsko, 20014
- Onkologikoa
-
-
Madrid
-
Aravaca, Madrid, Španělsko, 28023
- Hospital Universitario Sanitas la Zarzuela
-
Mostoles, Madrid, Španělsko, 28933
- Hospital Rey Juan Carlos
-
-
Murcia
-
El Palmar, Murcia, Španělsko, 30120
- Hospital Clínico Universitario Virgen de la Arrixaca
-
-
Pontevedra
-
Vigo, Pontevedra, Španělsko, 36200
- Hospital do Meixoeiro Complejo Hospitalario Universitario de Vigo
-
-
-
-
-
Basel, Švýcarsko, 4031
- Universitätsspital Basel
-
Bern, Švýcarsko, 3010
- Inselspital Bern
-
Thun, Švýcarsko, 3600
- Apotheke, Spital STS AG
-
Thun, Švýcarsko, 3600
- Onkologiezentrum Thun-Berner Oberland Spital Sts Ag
-
Zuerich, Švýcarsko, 8091
- Universitaetsspital Zuerich
-
Zuerich, Švýcarsko, 8006
- Kantonsapotheke Zuerich
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: PF-05280586
|
PF-05280586 (rituximab-Pfizer) concentrate for solution for infusion 375mg/m2 administered via IV infusion on Days 1, 8, 15, and 22
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|
Aktivní komparátor: MabThera®
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MabThera® (rituximab-EU) concentrate for solution for infusion 375mg/m2 administered via IV infusion on Days 1, 8, 15, and 22
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Overall Response Rate (ORR): Percentage of Participants With Overall Response (OR) at Week 26
Časové okno: Week 26
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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.
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Week 26
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Časové okno: Baseline up to Week 52
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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.
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Baseline up to Week 52
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Number of Participants With Treatment Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Časové okno: Baseline up to Week 52
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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.
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Baseline up to Week 52
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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
Časové okno: Baseline up to Week 52
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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.
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Baseline up to Week 52
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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
Časové okno: Baseline up to Week 52
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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.
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Baseline up to Week 52
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Number of Participants With Clinically Significant Laboratory Abnormalities
Časové okno: Baseline up to Week 52
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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.
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Baseline up to Week 52
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Time to Treatment Failure (TTF)
Časové okno: From randomization until disease progression, death or permanent discontinuation from treatment/study due to any reason, or up to Week 52
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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.
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From randomization until disease progression, death or permanent discontinuation from treatment/study due to any reason, or up to Week 52
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Progression-Free Survival (PFS)
Časové okno: From randomization until disease progression or death due to any cause or up to Week 52
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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.
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From randomization until disease progression or death due to any cause or up to Week 52
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Percentage of Participants With Complete Remission (CR) at Week 26
Časové okno: Week 26
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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.
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Week 26
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Duration of Response (DOR)
Časové okno: 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
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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.
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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
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Overall Survival
Časové okno: From randomization until death due to any cause or up to Week 52
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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.
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From randomization until death due to any cause or up to Week 52
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Maximum Observed Serum Concentration (Cmax) of PF-05280586 and Rituximab-EU
Časové okno: 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
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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
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Minimum Observed (Trough) Serum Concentration (Ctrough) of PF-05280586 and Rituximab-EU
Časové okno: Predose (within 4 hours prior to the start of dosing) on Day 1, 8, 15, and 22
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Predose (within 4 hours prior to the start of dosing) on Day 1, 8, 15, and 22
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Cluster of Differentiation (CD) 19-Positive B-Cell Counts
Časové okno: Baseline, Week 2, 3, 4, 5, 13, 26, 39, 52
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Baseline, Week 2, 3, 4, 5, 13, 26, 39, 52
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Number of Participants With Positive Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs)
Časové okno: Baseline up to Week 52
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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.
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Baseline up to Week 52
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Number of Participants Reporting Immune-Based Adverse Effects
Časové okno: Baseline up to Week 52
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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).
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Baseline up to Week 52
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- Courville J, Nastoupil L, Kaila N, Kelton J, Zhang J, Alcasid A, Nava-Parada P. Factors Influencing Infusion-Related Reactions Following Dosing of Reference Rituximab and PF-05280586, a Rituximab Biosimilar. BioDrugs. 2021 Jul;35(4):459-468. doi: 10.1007/s40259-021-00487-6. Epub 2021 Jun 21.
- Sharman JP, Liberati AM, Ishizawa K, Khan T, Robbins J, Alcasid A, Rosenberg JA, Aurer I. A Randomized, Double-Blind, Efficacy and Safety Study of PF-05280586 (a Rituximab Biosimilar) Compared with Rituximab Reference Product (MabThera(R)) in Subjects with Previously Untreated CD20-Positive, Low-Tumor-Burden Follicular Lymphoma (LTB-FL). BioDrugs. 2020 Apr;34(2):171-181. doi: 10.1007/s40259-019-00398-7.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
30. září 2014
Primární dokončení (Aktuální)
23. října 2017
Dokončení studie (Aktuální)
19. dubna 2018
Termíny zápisu do studia
První předloženo
7. srpna 2014
První předloženo, které splnilo kritéria kontroly kvality
7. srpna 2014
První zveřejněno (Odhad)
11. srpna 2014
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
20. června 2019
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
18. června 2019
Naposledy ověřeno
1. června 2019
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Onemocnění imunitního systému
- Novotvary podle histologického typu
- Novotvary
- Lymfoproliferativní poruchy
- Lymfatická onemocnění
- Imunoproliferativní poruchy
- Lymfom, Non-Hodgkin
- Lymfom
- Lymfom, folikulární
- Fyziologické účinky léků
- Antirevmatika
- Antineoplastická činidla
- Imunologické faktory
- Antineoplastická činidla, Imunologická
- Rituximab
Další identifikační čísla studie
- B3281006
- 2014-000132-41 (Číslo EudraCT)
- REFLECTIONS (Jiný identifikátor: Alias Study Number)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Ano
Popis plánu 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.
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .