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 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
394
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Brest, Belarus, 224027
- Healthcare Institution "Brest Regional Oncologic Dispensary"
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Minsk, Belarus, 220013
- Healthcare Institution 'Minsk City Clinical Oncology Dispensary'
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Republic Of Belarus, Belarus, 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, Belarus, 220013
- SI 'Republican Research and Practice Centre of Oncology and Medical Radiology n.a. N.N. Alexandrov'
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Lesnoy, Minsk Region, Belarus, 223040
- SI 'Republican Research and Practice Centre of Oncology and Medical Radiology n.a. N.N. Alexandrov'
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Brussels, Belgien, 1070
- Hôpital Erasme
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Brussels, Belgien, 1200
- Nuclear Medicine Department
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Charleroi, Belgien, 6000
- Grand Hopital de Charleroi-Site Notre-Dame
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Charleroi, Belgien, 6000
- PET/CT facility: Grand Hopital de Charleroi (GHdC) - site Notre-Dame
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Charleroi, Belgien, 6000
- Pharmacy Department: Grand Hopital de Charleroi (GHdC) - site Notre-Dame
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La Louviere (Haine-Saint Paul), Belgien, 7100
- Pharmacy Department, Centre Hospitalier De Jolimont - Lobbes
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La Louviere (Haine-Saint-Paul), Belgien, 7100
- Centre Hospitalier de Jolimont - Lobbes
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La Louviere (Haine-Saint-Paul), Belgien, 7100
- Radiology Department
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Mons, Belgien, 7000
- C.H.U. Ambroise Pare
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Mons, Belgien, 7000
- Pharmacy Department, CHU Ambroise Pare
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Sao Paulo, Brasilien, 01236-030
- IEP Sao Lucas - Instituto de Ensino e Pesquisa Sao Lucas / HEMOMED - Instituto de Oncologia e
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Sao Paulo, Brasilien, 01333-910
- Fleury
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Bahia
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Salvador, Bahia, Brasilien, 40050-410
- Hospital Santa Izabel - Setor de Bioimagem
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Salvador, Bahia, Brasilien, 40050-410
- Hospital Santa Izabel / Santa Casa de Misericordia da Bahia
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GO
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Goiania, GO, Brasilien, 74175-150
- Clinica Multimagem
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Goiania, GO, Brasilien, 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, Brasilien, 30130-100
- Centro de Imagens da Faculdade de Medicina - INCT Medicina Nuclear - PET/CT
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Belo Horizonte, MG, Brasilien, 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, Brasilien, 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, Brasilien, 90035-903
- Hospital de Clínicas de Porto Alegre
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Porto Alegre, RIO Grande DO SUL, Brasilien, 90035-903
- Central de Misturas Intravenosas do Hospital de Clinicas de Porto Alegre
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Porto Alegre, RIO Grande DO SUL, Brasilien, 90035-903
- Hospital de Clinicas de Porto Alegre - Centro de Pesquisa Clinica
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Porto Alegre, RIO Grande DO SUL, Brasilien, 90035-903
- Servico de Radiologia do Hospital de Clinicas de Porto Alegre
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RS
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Porto Alegre, RS, Brasilien, 90610-000
- CDI - Centro de Diagnostico por Imagem do Hospital Sao Lucas da PUCRS
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Porto Alegre, RS, Brasilien, 90610-000
- InsCer - Instituto do Cerebro do Rio Grande do Sul - PUCRS
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Porto Alegre, RS, Brasilien, 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, Brasilien, 17210-080
- Fundacao Amaral Carvalho / Fundacao Dr. Amaral Carvalho
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Jau, SAO Paulo, Brasilien, 17210-120
- Fundacao Amaral Carvalho / Fundacao Dr. Amaral Carvalho
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Jaú, SAO Paulo, Brasilien, 17210-120
- Unidade de Quimioterapia
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Santo Andre, SAO Paulo, Brasilien, 09030-340
- Casa da Esperanca
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Sao Bernardo do Campo, SAO Paulo, Brasilien, 09750-670
- TECNOLAB
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SP
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Campinas, SP, Brasilien, 13075-460
- CEMEDI
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Campinas, SP, Brasilien, 13075-460
- Instituto Radium
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Campinas, SP, Brasilien, 13087-567
- CAEP - Centro Avancado de Estudos e Pesquisas LTDA
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Campinas, SP, Brasilien, 13087-567
- Hospital e Maternidade Madre Theodora LTDA
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Campinas, SP, Brasilien, 13092-132
- CENNI Oncologia
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Santo Andre, SP, Brasilien, 09060-650
- Fundacao do ABC - FMABC/ Faculdade de Medicina ABC ( CEPHO - Centro de Estudos e Pesquisas de
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Sao Paulo, SP, Brasilien, 01506-000
- Hospital Bandeirantes
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Sao Paulo, SP, Brasilien, 05403-000
- Hospital das Clinicas da Faculdade de Medicina da USP / Fundacao Faculdade de Medicina MEC MPAS
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Sao Paulo, SP, Brasilien, 08270-070
- Casa de Saude Santa Marcelina (Centro de Pesquisa Santa Marcelina)
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São Paulo, SP, Brasilien, 01242-020
- IEP São Lucas (Pharmacy)
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Quezon City, Filippinerna, 1102
- St. Luke's Medical Center
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Metro Manila
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Manila, Metro Manila, Filippinerna, 1000
- University of Philippines Manila-Philippine General Hospital
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-
-
-
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Boulogne Sur Mer, Frankrike, 62321
- Hopital Duchenne Chu - Boulogne Sur Mer
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Bourg En Bresse Cedex, Frankrike, 01012
- Centre Hospitalier de Bourg en Bresse
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Brest, Frankrike, 29609
- Hopital Morvan-CHU Brest- Service Hematologie Clinique
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Caen, Frankrike, 14033
- Centre Hospitalier Universitaire Côte de Nacre
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Le Mans, Frankrike, 72037
- Centre Hospitalier du Mans
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Lyon, Frankrike, 69009
- Clinique de la Sauvegarde
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Marseille Cedex 05
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Marseille, Marseille Cedex 05, Frankrike, 13385
- CHU Marseille Hopital de La Conception
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Mulhouse Cedex
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Mulhouse, Mulhouse Cedex, Frankrike, 68100
- CH de Mulhouse, Hopital Emile Muller
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NAP
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Boulogne Sur Mer, NAP, Frankrike, 62321
- Hopital Duchenne Chu - Boulogne Sur Mer
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California
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Anaheim, California, Förenta staterna, 92801
- Pacific Cancer Medical Center, Inc.
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Anaheim, California, Förenta staterna, 92801
- The Oncology Institute of Hope and Innovation
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Corona, California, Förenta staterna, 92879
- Compassionate Care Research Group, Inc., at Compassionate Cancer Care Medical Group, Inc.
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Downey, California, Förenta staterna, 90241
- The Oncology Institute of Hope and Innovation
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Fountain Valley, California, Förenta staterna, 92708
- Compassionate Care Research Group, Inc., at Compassionate Cancer Care Medical Group, Inc.
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Gilroy, California, Förenta staterna, 95020
- Global Cancer Research Institute (GCRI), Inc
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Gilroy, California, Förenta staterna, 95020
- Saint Louise Regional Hospital Radiology Department (Radiology Only)
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Gilroy, California, Förenta staterna, 95020
- South Valley Imaging Center (Imaging Only)
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Glendale, California, Förenta staterna, 91204
- Los Angeles Hematology Oncology Medical Group
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Glendale, California, Förenta staterna, 91204
- The Oncology Institute of Hope and Innovation
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Glendale, California, Förenta staterna, 91206
- Los Angeles Hematology Oncology Medical Group
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Long Beach, California, Förenta staterna, 90805
- The Oncology Institute of Hope and Innovation
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Los Angeles, California, Förenta staterna, 90017
- Los Angeles Hematology Oncology Medical Group
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Los Angeles, California, Förenta staterna, 90057
- Los Angeles Hematology Oncology Medical Group
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Lynwood, California, Förenta staterna, 90262
- The Oncology Institute of Hope and Innovation
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Montebello, California, Förenta staterna, 90640
- The Oncology Institute of Hope and Innovation
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Palm Springs, California, Förenta staterna, 92262
- Comprehensive Cancer Center at Desert Regional Medical Center
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Redondo Beach, California, Förenta staterna, 90277
- Torrance Health Association DBA, Torrance Memorial Physician, Network/Cancer Care Associates
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Riverside, California, Förenta staterna, 92501
- Compassionate Care Research Group, Inc., at Compassionate Cancer Care Medical Group, Inc.
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San Jose, California, Förenta staterna, 95128
- O'Connor Hospital
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San Jose, California, Förenta staterna, 95124
- Global Cancer Research Institute, Inc.
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San Jose, California, Förenta staterna, 95128
- PET Imaging of San Jose (Imaging Only)
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Santa Ana, California, Förenta staterna, 92705
- The Oncology Institute of Hope and Innovation
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Torrance, California, Förenta staterna, 90505
- Torrance Memorial Medical Center
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Whittier, California, Förenta staterna, 90603
- Innovative Clinical Research Institute (ICRI)
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Whittier, California, Förenta staterna, 90602
- The Oncology Institute of Hope and Innovation
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Colorado
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Aurora, Colorado, Förenta staterna, 80012
- Rocky Mountain Cancer Centers
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Boulder, Colorado, Förenta staterna, 80303
- Rocky Mountain Cancer Centers
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Denver, Colorado, Förenta staterna, 80218
- Rocky Mountain Cancer Centers
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Lakewood, Colorado, Förenta staterna, 80228
- Rocky Mountain Cancer Center-Lakewood (Laboratory)
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Lakewood, Colorado, Förenta staterna, 80228
- Rocky Mountain Cancer Centers (RMCC) - Lakewood - St Anthony
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Lone Tree, Colorado, Förenta staterna, 80124
- Rocky Mountain Cancer Centers
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Pueblo, Colorado, Förenta staterna, 81008
- Rocky Mountain Cancer Center Pueblo
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Georgia
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Thomasville, Georgia, Förenta staterna, 31792
- John D. Archbold Memorial Hospital
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Thomasville, Georgia, Förenta staterna, 31792
- Lewis Hall Singletary Oncology Center at John D. Archbold Memorial Hospital
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Illinois
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DeKalb, Illinois, Förenta staterna, 60115
- Northwestern Medicine West Region
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Geneva, Illinois, Förenta staterna, 60134
- Cancer Center,Northwestern Medicine, West Region
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Kansas
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Chanute, Kansas, Förenta staterna, 66720
- Cancer Center of Kansas
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Dodge City, Kansas, Förenta staterna, 67801
- Cancer Center of Kansas
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El Dorado, Kansas, Förenta staterna, 67042
- Cancer Center of Kansas
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Independence, Kansas, Förenta staterna, 67301
- Cancer Center of Kansas
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Kingman, Kansas, Förenta staterna, 67068
- Cancer Center of Kansas
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Liberal, Kansas, Förenta staterna, 67905
- Cancer Center of Kansas
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McPherson, Kansas, Förenta staterna, 67460
- Cancer Center of Kansas
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Newton, Kansas, Förenta staterna, 67114
- Cancer Center of Kansas
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Overland Park, Kansas, Förenta staterna, 66210
- The University of Kansas Cancer Center
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Parsons, Kansas, Förenta staterna, 67357
- Cancer Center of Kansas
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Salina, Kansas, Förenta staterna, 67401
- Cancer Center of Kansas
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Wellington, Kansas, Förenta staterna, 67152
- Cancer Center of Kansas
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Wichita, Kansas, Förenta staterna, 67214
- Cancer Center of Kansas
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Wichita, Kansas, Förenta staterna, 67208
- Cancer Center of Kansas
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Winfield, Kansas, Förenta staterna, 67156
- Cancer Center of Kansas
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Maryland
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Baltimore, Maryland, Förenta staterna, 21229
- Saint Agnes Hospital
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Baltimore, Maryland, Förenta staterna, 21229
- PET/CT facility Seton Imaging Center
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Bethesda, Maryland, Förenta staterna, 20817
- Rcca Md Llc
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Silver Spring, Maryland, Förenta staterna, 20910
- Holy Cross Hospital
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Silver Spring, Maryland, Förenta staterna, 20902
- Holy Cross Hospital Resource Center
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Silver Spring, Maryland, Förenta staterna, 20910
- Holy Cross Hospital Hospital Pharmacy
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Wheaton, Maryland, Förenta staterna, 20902
- Maryland Oncology Hematology, P.A.
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Missouri
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Kansas City, Missouri, Förenta staterna, 64131
- The University of Kansas Cancer Center
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Kansas City, Missouri, Förenta staterna, 64154
- The University of Kansas Cancer Center
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Lee's Summit, Missouri, Förenta staterna, 64064
- The University of Kansas Cancer Center
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Nebraska
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Grand Island, Nebraska, Förenta staterna, 68803
- Saint Francis Medical Center, Saint Francis Cancer Treatment Center
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Grand Island, Nebraska, Förenta staterna, 68803
- Saint Francis Medical Center
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Hastings, Nebraska, Förenta staterna, 68901
- Saint Francis Medical Center, Saint Francis Cancer Treatment Center
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Nevada
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Henderson, Nevada, Förenta staterna, 89074
- Comprehensive Cancer Centers of Nevada
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Henderson, Nevada, Förenta staterna, 89052
- Comprehensive Cancer Centers of Nevada
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Las Vegas, Nevada, Förenta staterna, 89148
- Comprehensive Cancer Centers of Nevada
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Las Vegas, Nevada, Förenta staterna, 89128
- Comprehensive Cancer Centers of Nevada
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Las Vegas, Nevada, Förenta staterna, 89169
- Comprehensive Cancer Centers of Nevada
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North Carolina
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Greenville, North Carolina, Förenta staterna, 27834
- Vidant Medical Center
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Greenville, North Carolina, Förenta staterna, 27834
- Brody School of Medicine at East Carolina University
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Greenville, North Carolina, Förenta staterna, 27834
- Vidant Medical Center Pharmacy
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Ohio
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Maumee, Ohio, Förenta staterna, 43537
- Toledo Clinic Cancer Center - Maumee
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Toledo, Ohio, Förenta staterna, 43623
- Toledo Clinic Cancer Center - Toledo
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Toledo, Ohio, Förenta staterna, 43623
- Toledo Clinic, Inc.
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Oregon
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Eugene, Oregon, Förenta staterna, 97401
- Willamette Valley Cancer Institute and Research Center
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Tennessee
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Knoxville, Tennessee, Förenta staterna, 37920
- University of Tennessee Medical Center
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Texas
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Fort Sam Houston, Texas, Förenta staterna, 78234
- San Antonio Military Medical Center
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Fort Sam Houston, Texas, Förenta staterna, 78234
- San Antonio Military Medical Center- Department of Pharmacy
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Fort Sam Houston, Texas, Förenta staterna, 78234
- San Antonio Military Medical Center- Department of Radiology
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Fort Worth, Texas, Förenta staterna, 76177
- Investigational Products Center (IPC)
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Fort Worth, Texas, Förenta staterna, 76177
- Investigational Products Center (I PC)
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Houston, Texas, Förenta staterna, 77090
- Millennium Oncology
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Irving, Texas, Förenta staterna, 75063
- US Oncology Investigational Products Center (IPC)
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Kingwood, Texas, Förenta staterna, 77339
- Millennium Oncology
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Longview, Texas, Förenta staterna, 75601
- Texas Oncology - Longview Cancer Center
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Shenandoah, Texas, Förenta staterna, 77384
- Millennium Oncology
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The Woodlands, Texas, Förenta staterna, 77380
- Millennium Oncology
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Tyler, Texas, Förenta staterna, 75702
- Texas Oncology-Tyler
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Washington
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Yakima, Washington, Förenta staterna, 98902
- Yakima Valley Memorial Hospital/North Star Lodge Cancer Center
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Tbilisi, Georgien, 0144
- High Technology Medical Center, University Clinic
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Tbilisi, Georgien, 0112
- "LTD ""M. Zodelava's Hematology Centre"""
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Tbilisi, Georgien, 0112
- LTD "Research Institute of Clinical Medicine"
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Athens, Grekland, 10676
- Gen. Hosp. of Athens "Evangelismos - Eye Hosp.- Polikliniki"
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Athens, Grekland, 10676
- Gen. Hosp. of Athens "Evangelismos-Eye Hosp. - Polikliniki"
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Athens, Grekland, 10676
- Gen. Hosp. of Athens "Evangelismos-Eye Hosp.-Polikliniki"
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Athens, Grekland, 10676
- Gen.Hosp.of Athens "Evangelismos-Eye Hosp.-polikiliniki"
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Athens, Grekland, 10676
- General Hospital of Athens "Evangelismos - Eye Hosp. - Polikliniki"
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Athens, Grekland, 11526
- Bioiatriki S.A.
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Athens, Grekland, 11526
- Bioiatriki
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Athens, Grekland, 11527
- General Hospital of Athens 'Laiko'
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Athens, Grekland, 12462
- """ATTIKON"" Gen. Univ. Hosp"
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Chaidari, Athens, Grekland, 12462
- "ATTIKON'' Gen. Univ. Hosp.
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Patras, Grekland, 26504
- University General Hospital of Patras
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Patras, Grekland, 26222
- Magnitiki Patron
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-
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New Delhi, Indien, 110 085
- Rajiv Gandhi Cancer Institute & Research Center (RGCIRC)
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Gujarat
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Surat, Gujarat, Indien, 395001
- Super Scan Imaging Centre
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Surat, Gujarat, Indien, 395002
- Pathology Department, Unique Hospital Multispeciality & Research Institute
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Surat, Gujarat, Indien, 395002
- Zircon- BIC Imaging Centre
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Karanataka
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Mangalore, Karanataka, Indien, 575002
- Mangalore Institute of Oncology
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Karnataka
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Bangalore, Karnataka, Indien, 560027
- Healthcare Global Enterprises Limited
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Manipal, Karnataka, Indien, 576104
- Kasturba Medical College and Hospital
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Maharashtra
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Nashik, Maharashtra, Indien, 422004
- Curie Manavata Cancer Centre
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Nashik, Maharashtra, Indien, 422004
- Department of Radiology, Curie Manavata Cancer Centre
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Pune, Maharashtra, Indien, 411001
- Ruby Hall Clinic
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Pune, Maharashtra, Indien, 411001
- Department of Radiology
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Pune, Maharashtra, Indien, 411001
- Jehangir Clinical Development Centre Pvt. Ltd.
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Rajasthan
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Jaipur, Rajasthan, Indien, 302004
- R.K. Birla Cancer Center, Sawai Man Singh Hospital
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Tamilnadu
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Chennai, Tamilnadu, Indien, 600035
- Apollo Speciality Hospital
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Chennai, Tamilnadu, Indien, 600035
- Department of Radiology
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Telangana
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Hyderabad, Telangana, Indien, 500 004
- Global Hospitals
-
Hyderabad, Telangana, Indien, 500029
- Vijaya Diagnostic Centre
-
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WEST Bengal
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Kolkata, WEST Bengal, Indien, 700014
- N.R.S Medical College and Hospital
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Kolkata, WEST Bengal, Indien, 700014
- Spandan PET-CT Unit
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-
-
-
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Genova, Italien, 16132
- IRCSS A.O.U. San Martino - IST - UO Clinica Ematologica
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Milano, Italien, 20133
- SC Ematologia, Fondazione IRCCS Ist Nazionale dei Tumori
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Parma, Italien, 43100
- Padiglione 1, Torre delle medicine, 6 piano
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Pesaro, Italien, 61122
- Ematologia e Centro Trapianti - AZ Osp. Ospedali Riuniti Marche Nord (AORMN) - Presidio S. Salvatore
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Pisa, Italien, 56126
- U.O. Ematologia Universitaria - Dip. Di Oncologia dei Trapianti - AOU Pisana
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Roma, Italien, 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, Italien, 26100
- U.O. di Ematologia e CTMO - Istituti Ospedalieri di Cremona
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FC
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Meldola, FC, Italien, 47014
- IRST - IRCCS U. O. Oncologia Medica
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GE
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Genova, GE, Italien, 16132
- U.O. Ematologia 1 - IRCCS AOU San Martino-IST
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MB
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Monza, MB, Italien, 20900
- Unita di Ricerca Clinica
-
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MI
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Milano, MI, Italien, 20141
- Istituto Europeo Di Oncologia
-
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NAP
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Latina, NAP, Italien, 04100
- Unità semplice di Medicina Nucleare
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-
PG
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Terni, PG, Italien, 05100
- Az Ospedaliera Santa Maria
-
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Palermo
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Torrette Ancona, Palermo, Italien, 60121
- Clinica Ematologica - A.O.U. Ospedali Riuniti di Ancona
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Reggio
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Reggio Emilia, Reggio, Italien, 42123
- Medicina nucleare
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Reggio Emilia, Reggio, Italien, 42123
- Radiologia
-
Reggio Emilia, Reggio, Italien, 42123
- SC Ematologia - SC Ematologia - Arcispedale Santa Maria Nuova - IRCCS
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Rome Rm
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Rome, Rome Rm, Italien, 00161
- "Dipartimento di Biotecnologie Cellulari ed Ematologia, Universita ""Sapienza""
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-
-
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Fukuoka, Japan, 811-0213
- Fukuoka Wajiro PET Diagnostic Imaging Clinic
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Nagano, Japan, 399-8701
- National Hospital Organization Matsumoto Medical Center
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Tokyo, Japan, 2080022
- Musashimurayama Hospital
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Aichi
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Nagoya, Aichi, Japan, 466-8650
- Nagoya Daini Red Cross Hospital
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Nagoya, Aichi, Japan, 464-0044
- East Nagoya Imaging Diagnosis Center
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Akita
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Akita City, Akita, Japan, 010-8543
- Akita University Hospital
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Chiba
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Chiba-shi, Chiba, Japan, 260-8717
- Chiba Cancer Center
-
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Fukuoka
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Fukuoka-Shi, Fukuoka, Japan, 811-1395
- National Hospital Organization Kyushu Cancer Center
-
Fukuoka-shi, Fukuoka, Japan, 810-8563
- National Hospital Organization Kyushu Medical Center
-
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Hyogo
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Kobe-City, Hyogo, Japan, 650-0047
- Kobe City Medical Center General Hospital
-
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Ishikawa
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Kanazawa, Ishikawa, Japan, 920-8650
- National Hospital Organization Kanazawa Medical Center
-
Kanazawa, Ishikawa, Japan, 9200934
- Kanazawa Advanced Medical Center
-
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Kanagawa-ken
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Yokohama-shi, Kanagawa-ken, Japan, 224-8503
- Showa University Northern Yokohama Hospital
-
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Kochi
-
Okocho, Nankoku, Kochi, Japan, 783-8505
- Kochi Medical School Hospital
-
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Kumamoto-ken
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Kumamoto-shi, Kumamoto-ken, Japan, 860-0008
- National Hospital Organization Kumamoto Medical Center
-
Kumamoto-shi, Kumamoto-ken, Japan, 862-0941
- Uozumi Clinic
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Miyagi
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Sendai-shi, Miyagi, Japan, 983-8520
- National Hospital Organization Sendai Medical Center
-
Sendai-shi, Miyagi, Japan, 980-0873
- Sendai Kousei Hospital
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Nagano
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Matsumoto-shi, Nagano, Japan, 390-8510
- Aizawa Hospital
-
Nagano-shi, Nagano, Japan, 380-8582
- Nagano Red Cross Hospital
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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
-
-
-
-
-
Ankara, Kalkon, 06100
- Hacettepe Universitesi Tip Fakultesi Onkoloji Hastanesi
-
Ankara, Kalkon, 06200
- Dr. Abdurrahman Yurtaslan Ankara Onkoloji Eg. ve Aras.
-
Ankara, Kalkon, 06420
- Ultramar Tibbi Gorunteleme Merkezi
-
Ankara, Kalkon, 06420
- Ultramar Tibbi Goruntuleme Merkezi
-
Ankara, Kalkon, 06540
- Integra Gurses Teshis Tedavi ve Saglik Hizmetleri A.S.
-
Aydin, Kalkon, 09010
- Adnan Menderes University Medical Faculty
-
Gaziantep, Kalkon, 27310
- Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi
-
Gaziantep, Kalkon, 27310
- Gaziantep Universitesi Sahinbey Arastirma ve Uygulama
-
Istanbul, Kalkon, 34093
- Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
-
Izmir, Kalkon, 35040
- Ege Universitesi Tip Fakultesi Ic Hastaliklari Anabilim Dali
-
Izmir, Kalkon, 35040
- EGE-RAD Bilgisayarli Tomografi Ozel Saglik Hizmetleri ve Malzemeleri Tic.Ltd.Sti.
-
Kayseri, Kalkon, 38100
- Erciyes Universitesi Tip Fakultesi Nukleer Tip Laboratuvari
-
Kayseri, Kalkon, 38100
- Erciyes Universitesi Tip Fakultesi Radyoloji Laboratuvari
-
Kayseri, Kalkon, 38100
- Erciyes Universitesi Tip Fakultesi
-
Malatya, Kalkon, 44280
- Inonu Universitesi Tip Fakultesi Turgut Ozal Tip Merkezi
-
Manisa, Kalkon, 45000
- Celal Bayar University Medical Faculty
-
Samsun, Kalkon, 55139
- Ondokuz Mayis Universitesi Tip Fakultesi
-
-
-
-
-
Busan, Korea, Republiken av, 47392
- Inje University Busan Paik Hospital
-
Seoul, Korea, Republiken av, 03080
- Seoul National University Hospital
-
Seoul, Korea, Republiken av, 06351
- Samsung Medical Center
-
-
Gyeonggi-do
-
Anyang-si, Gyeonggi-do, Korea, Republiken av, 14068
- Hallym University Sacred Heart Hospital
-
Seongnam-si, Gyeonggi-do, Korea, Republiken av, 463-707
- Seoul National University Bundang Hospital
-
-
Jeollabuk-do
-
Jeonju-si, Jeollabuk-do, Korea, Republiken av, 54907
- Chonbuk National University Hospital
-
-
Korea
-
Ulsan, Korea, Korea, Republiken av, 44033
- Ulsan University Hospital
-
-
-
-
-
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"
-
-
-
-
-
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
-
-
-
-
-
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 Medico 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
-
-
-
-
-
Lima, Peru, 18
- Pet Scan Peru
-
Lima, Peru, 18
- Resocentro
-
-
Lima
-
Surquillo, Lima, Peru, 34
- Instituto Nacional de Enfermedades Neoplasicas
-
-
-
-
-
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
-
-
-
-
-
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.
-
-
-
-
-
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
-
-
-
-
-
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.
-
-
-
-
-
Chelyabinsk, Ryska Federationen, 454087
- "State Budget Healthcare Institution ""Chelyabinsk Regional Clinical Center of Oncology
-
Moscow, Ryska Federationen, 121309
- LLC "Vitamed"
-
Moscow, Ryska Federationen, 115478
- FSBSI 'N.N.Blokhin Russian Cancer Research Center' of MoH of RF
-
Moscow, Ryska Federationen, 115478
- Russian Cancer Research Centre them N.N. Blokhin
-
Moscow, Ryska Federationen, 125284
- SBHI of Moscow City Clinical Hospital n.a. S.P.Botkin of Healthcare Department of Moscow
-
Moscow, Ryska Federationen, 127473
- Ramsay Diagnostics
-
Saint Petersburg, Ryska Federationen, 194291
- State Budgetary Institution of Healthcare "Leningrad Regional Clinical Hospital"
-
Saint-Petersburg, Ryska Federationen, 194214
- Dr. Berezin Medical Institute
-
Saint-Petersburg, Ryska Federationen, 197376
- N.P. Bechtereva Institute of Human Brain of the Russian Academy of Sciences
-
Saint-Petersburg, Ryska Federationen, 197376
- N.P. Bechtereva Institute of the Human Brain of the Russian Academy of Sciences
-
Saint-Petersurg, Ryska Federationen, 195271
- Non-state healthcare institution "Road Clinical Hospital of Joint Stock Company "Russian Railways"
-
Yaroslavl, Ryska Federationen, 150010
- Yaroslavl State Medical Academy
-
Yaroslavl, Ryska Federationen, 150062
- GBUZ of Yaroslavl Region "Regional Clinical Hospital"
-
-
Kaluga Region
-
Obninsk, Kaluga Region, Ryska Federationen, 249036
- A.Tsyb Medical Radiological Research Centre -
-
-
Mordovian Republic
-
Saransk, Mordovian Republic, Ryska Federationen, 430032
- State Healthcare Institution Republican Oncology Dispensary
-
-
Nizhniy Novgorod Region
-
Nizhniy Novgorod, Nizhniy Novgorod Region, Ryska Federationen, 603126
- "SBHI of NNR ""Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko"""
-
Nizhniy Novgorod, Nizhniy Novgorod Region, Ryska Federationen, 603126
- LLC MC "MRT-Diagnostika"
-
-
Pesochniy
-
Saint-Petersburg, Pesochniy, Ryska Federationen, 197758
- FSBI "Russian Research Centre of Radiology and Surgical Technologies n.a. A.M. Granov" of MoH of RF
-
Saint-Petersburg, Pesochniy, Ryska Federationen, 197758
- FSBI "Russian Research Centre of Radiology and Surgical Technologies named after academician
-
Saint-Petersburg, Pesochniy, Ryska Federationen, 197758
- FSBI "Russian Research Centre of Radiology and Surgical Technologies
-
-
Pesochniy TOWN
-
Saint-Petersburg, Pesochniy TOWN, Ryska Federationen, 197758
- FSBI "Russian Research Centre of Radiology and Surgical Technologies" of MoH of RF
-
Saint-Petersburg, Pesochniy TOWN, Ryska Federationen, 197758
- FSBI "Russian Research Centre of Radiology and Surgical Technologies"
-
Saint-Petersburg, Pesochniy TOWN, Ryska Federationen, 197758
- FSBI "Russian Research Centre of Radiology and Surgical Technologies
-
Saint-Petersburg, Pesochniy TOWN, Ryska Federationen, 197758
- FSBI 'Russian Research Centre of Radiology and Surgical Technologies
-
-
Pos.pesochny
-
Saint-Petersburg, Pos.pesochny, Ryska Federationen, 197758
- FSBI 'National Medical Oncology Research Centre n.a. N.N.Petrov'
-
-
Republic Bashkortostan
-
Ufa, Republic Bashkortostan, Ryska Federationen, 450054
- Branch office of LLC 'PET-Technology' at Ufa city
-
Ufa, Republic Bashkortostan, Ryska Federationen, 450054
- State Budgetary Healthcare Institution "Republican Clinical Oncology Dispensary of the Ministry
-
-
Saint Petersburg
-
Pushkin, Saint Petersburg, Ryska Federationen, 196603
- Private Medical Institution "Euromedservice"
-
-
Saint-petersburg
-
Pesochniy Town, Saint-petersburg, Ryska Federationen, 197758
- FSBI "Russian Research Centre of Radiology and Surgical Technologies" of MoH of RF
-
-
Stavropol Region
-
Lermontov, Stavropol Region, Ryska Federationen, 357340
- Federal State-Financed Institution 'North-Caucasian Research and Clinical Center'
-
Pyatigorsk, Stavropol Region, Ryska Federationen, 357502
- SBHI of Stavropol Region "Pyatigorsk Interdistrict Oncology Dispensary
-
-
-
-
-
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
-
-
-
-
-
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 Fundacion Jimenez Diaz
-
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 Rocio
-
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 Clinico Universitario Virgen de la Arrixaca
-
-
Pontevedra
-
Vigo, Pontevedra, Spanien, 36200
- Hospital do Meixoeiro Complejo Hospitalario Universitario de Vigo
-
-
-
-
-
Bath, Storbritannien, BA1 3NG
- Royal United Hospitals Bath NHS Foundation Trust
-
London, Storbritannien, EC1A 7BE
- Barts Health NHS Trust
-
Newcastle upon Tyne, Storbritannien, NE4 6BE
- Positron Emission Tomography (PET) Centre
-
Sunderland, Storbritannien, SR4 7TP
- City Hospitals Sunderland NHS Foundation Trust-Sunderland Royal Hospital
-
Sunderland, Storbritannien, SR4 7TP
- Diagnostic Imaging
-
-
Essex
-
Westcliff-On-Sea, Essex, Storbritannien, SS0 0RY
- Southend University Hospital NHS Foundation Trust
-
-
Glos.
-
Cheltenham, Glos., Storbritannien, GL53 7AS
- Cobalt Diagnostic Imaging
-
-
-
-
Gauteng
-
Groenkloof, Gauteng, Sydafrika, 0181
- NIKSCH & PARTNERS t/a CAPITAL RADIOLOGY
-
Johannesburg, Gauteng, Sydafrika, 2196
- The Medical Oncology Centre of Rosebank
-
Pretoria, Gauteng, Sydafrika, 0002
- Department of Medical Oncology, University of Pretoria, Steve Biko Academic Hospitals Complex
-
Pretoria, Gauteng, Sydafrika, 0044
- Albert Alberts Stem Cell Transplant Centre
-
Pretoria, Gauteng, Sydafrika, 0044
- Dr JN De Jong and Partners t/a East Rad
-
Pretoria, Gauteng, Sydafrika, 0181
- NIKSCH & PARTNERS t/a CAPITAL RADIOLOGY
-
Rosebank, Gauteng, Sydafrika, 2196
- Drs Sulman & Partners Specialist Radiologists
-
Sandton, Gauteng, Sydafrika, 2191
- Drs Bloch & Partners Incorporated
-
-
-
-
-
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
-
-
-
-
-
Berlin, Tyskland, 13353
- Charité - Universitätsmedizin Berlin
-
Berlin, Tyskland, 12200
- Charite - Universitaetsmedizin Berlin
-
Berlin, Tyskland, 12200
- Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin
-
Berlin, Tyskland, 13353
- Charite - Universitaetsmedizin Berlin, Campus Virchow-Klinikum
-
Berlin, Tyskland, 13353
- Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum
-
Chemnitz, Tyskland, 09113
- Klinikum Chemnitz gGMbH
-
Chemnitz, Tyskland, 09113
- Klinikum Chemnitz gGmbH - Institut fuer Interventionelle Radiologie und Neuroradiologie
-
Chemnitz, Tyskland, 09116
- Klinikum Chemnitz gGmbH - Klinik fuer Nuklearmedizin
-
Chemnitz, Tyskland, 09116
- Klinikum Chemnitz gGmbH - Zentralapotheke
-
Essen, Tyskland, 45147
- Universitaetsklinikum Essen (AoeR)
-
Essen, Tyskland, 45147
- Universitätsklinikum Essen (AöR)
-
Herne, Tyskland, 44623
- DokuSan Gesellschaft fuer Medizinische Studien mbH & Co. KG
-
Herne, Tyskland, 44649
- Apotheke des St. Anna Hospital
-
Herne, Tyskland, 44651
- EVK Eickel
-
Koeln, Tyskland, 50679
- Praxis im Koeln Triangle
-
Mutlangen, Tyskland, 73557
- Gemeinschaftspraxis fuer Diagnostische Radiologie und Nuklearmedizin
-
Mutlangen, Tyskland, 73557
- Kliniken Ostalb, Stauferklinikum Schwaebisch Gmuend, Zentrum fuer Innere Medizin
-
Mutlangen, Tyskland, 73557
- Stauferklinikum Schwaebisch Gmuend, Apotheke
-
Rostock, Tyskland, 18057
- Universitaetsmedizin Rostock
-
Stuttgart, Tyskland, 70174
- Klinikum Stuttgart, Klinik fuer Nuklearmedizin
-
Stuttgart, Tyskland, 70199
- Vinzenz von Paul Kliniken GgmbH
-
Troisdorf, Tyskland, 53840
- Radiologie Rhein-Sieg
-
Troisdorf, Tyskland, 53840
- Ueberoertliche Berufsausuebungsgemeinschaft Drs. med. Helmut Forstbauer
-
Troisdorf, Tyskland, 53842
- Zentralapotheke
-
-
-
-
-
Chernivtsi, Ukraina, 58013
- "Municipal Institution ""Chernivtsi Regional Clinical Oncology Center"",
-
Dnipropetrovsk, Ukraina, 49102
- MI 'City Dnipropetrovsk Multi-field Clin. Hospital #4 of DRC',
-
Kharkiv, Ukraina, 61070
- Municipal Non-Profit Enterprise "Regional Oncology Centre"
-
Kyiv, Ukraina, 03022
- National Cancer Institute
-
Uzhhorod, Ukraina, 88017
- "Central City Clinical Hospital, City Oncology Center, SHEI ""Uzhhorod National University"", Chair
-
Vinnytsia, Ukraina, 21029
- Podilskyy Regional Oncology Center, Chemotherapy Department
-
Zaporizhzhia, Ukraina, 69040
- Municipal Establishment 'Zaporizhzhia Regional Clinical Oncology Dispensary'
-
Zaporizhzhia, Ukraina, 69076
- LLC "Diaservis"
-
-
KYIV Region
-
Obukhiv, KYIV Region, Ukraina, 08720
- "MedX-Ray International Group" LLC
-
Obukhiv District, KYIV Region, Ukraina, 08720
- "Mediks-rey International Group" LLC
-
Obukhiv District, KYIV Region, Ukraina, 08720
- "MedX-rey International Group" LLC
-
-
-
-
-
Linz, Österrike, 4010
- Krankenhaus Der Barmherzigen Schwestern Linz
-
Linz, Österrike, 4020
- Kepler Universitaetsklinikum GmbH
-
Linz, Österrike, 4021
- Kepler Universitaetsklinikum GmbH
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: PF-05280586
|
PF-05280586 (rituximab-Pfizer) concentrate for solution for infusion 375mg/m2 administered via IV infusion on Days 1, 8, 15, and 22
|
|
Aktiv komparator: MabThera®
|
MabThera® (rituximab-EU) concentrate for solution for infusion 375mg/m2 administered via IV infusion on Days 1, 8, 15, and 22
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Overall Response Rate (ORR): Percentage of Participants With Overall Response (OR) at Week 26
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsram: 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)
Tidsram: 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.
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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
Tidsram: 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
Tidsram: 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.
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Baseline up to Week 52
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|
Number of Participants With Clinically Significant Laboratory Abnormalities
Tidsram: 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.
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Baseline up to Week 52
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Time to Treatment Failure (TTF)
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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.
|
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
Tidsram: 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
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Maximum Observed Serum Concentration (Cmax) of PF-05280586 and Rituximab-EU
Tidsram: 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
Tidsram: 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
|
|
|
Cluster of Differentiation (CD) 19-Positive B-Cell Counts
Tidsram: Baseline, Week 2, 3, 4, 5, 13, 26, 39, 52
|
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)
Tidsram: 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.
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Baseline up to Week 52
|
|
Number of Participants Reporting Immune-Based Adverse Effects
Tidsram: 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).
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Baseline up to Week 52
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
30 september 2014
Primärt slutförande (Faktisk)
23 oktober 2017
Avslutad studie (Faktisk)
19 april 2018
Studieregistreringsdatum
Först inskickad
7 augusti 2014
Först inskickad som uppfyllde QC-kriterierna
7 augusti 2014
Första postat (Uppskatta)
11 augusti 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
20 juni 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
18 juni 2019
Senast verifierad
1 juni 2019
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Immunsystemets sjukdomar
- Neoplasmer efter histologisk typ
- Neoplasmer
- Lymfoproliferativa störningar
- Lymfatiska sjukdomar
- Immunproliferativa störningar
- Lymfom, icke-Hodgkin
- Lymfom
- Lymfom, follikulärt
- Läkemedels fysiologiska effekter
- Antireumatiska medel
- Antineoplastiska medel
- Immunologiska faktorer
- Antineoplastiska medel, immunologiska
- Rituximab
Andra studie-ID-nummer
- B3281006
- 2014-000132-41 (EudraCT-nummer)
- REFLECTIONS (Annan identifierare: Alias Study Number)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Ja
IPD-planbeskrivning
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.
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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