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A Study Of PF-05280586 (Rituximab-Pfizer) Or MabThera® (Rituximab-EU) For The First-Line Treatment Of Patients With CD20-Positive, Low Tumor Burden, Follicular Lymphoma (REFLECTIONS B328-06)

18. juni 2019 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

394

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: PF-05280586
Biologisk: 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®
Biologisk: MabThera®
MabThera® (rituximab-EU) concentrate for solution for infusion 375mg/m2 administered via IV infusion on Days 1, 8, 15, and 22

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Response Rate (ORR): Percentage of Participants With Overall Response (OR) at Week 26
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsramme: 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)
Tidsramme: Baseline up to Week 52
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events after first dose of study drug that were absent before treatment or that worsened relative to pretreatment state. Relatedness to treatment was assessed by investigator. AEs included both serious and non-serious AEs.
Baseline up to Week 52
Number of Participants With Grade 3 or Higher Treatment-Emergent Adverse Events (AEs) as Graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03
Tidsramme: Baseline up to Week 52
An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 1=Mild, asymptomatic or mild symptoms, Grade 2=Moderate; minimal, local or noninvasive intervention indicated, Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life threatening) events caused participant to be in imminent danger of death. Grade 5 = death. Treatment-emergent were events after first dose of study drug that were absent before treatment or that worsened relative to pretreatment state.
Baseline up to Week 52
Number of Participants With Grade 3 or Higher Treatment-Related Treatment-Emergent Adverse Events (AEs) as Graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03
Tidsramme: Baseline up to Week 52
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Grade 1=Mild, asymptomatic or mild symptoms, Grade 2=Moderate; minimal, local or noninvasive intervention indicated; Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. Grade 5 = death. Treatment-emergent were events after first dose of study drug that were absent before treatment or that worsened relative to pretreatment state.
Baseline up to Week 52
Number of Participants With Clinically Significant Laboratory Abnormalities
Tidsramme: Baseline up to Week 52
Criteria for clinically significant laboratory abnormalities included total bilirubin (TB) less than (<) 2*upper limit of normal (ULN), alanine aminotransferase (ALT)<3*ULN; TB<2*ULN, ALT more than (>) 3 equal to (=) *ULN; TB<2*ULN, aspartate aminotransferase (AST)<3*ULN; TB<2*ULN, AST>=3*ULN. Data for only those categories are reported for which at least one participant had clinically significant laboratory abnormality.
Baseline up to Week 52
Time to Treatment Failure (TTF)
Tidsramme: From randomization until disease progression, death or permanent discontinuation from treatment/study due to any reason, or up to Week 52
TTF was defined as the time (in months) from date of randomization to first progression of disease based on central review, death due to any cause, or permanent discontinuation from treatment, or discontinuation from study for any reason, whichever came first. Progression was defined as any new lesion or increase by greater than or equal to (>=) 50% of previously involved sites from nadir. TTF was calculated using Kaplan-Meier method.
From randomization until disease progression, death or permanent discontinuation from treatment/study due to any reason, or up to Week 52
Progression-Free Survival (PFS)
Tidsramme: From randomization until disease progression or death due to any cause or up to Week 52
PFS was defined as the time (in months) from date of randomization to first progression of disease (PD) based on central review or death due to any cause in the absence of documented PD. PD was defined as any new lesion or increase by >=50% of previously involved sites from nadir. PFS was calculated using Kaplan-Meier method.
From randomization until disease progression or death due to any cause or up to Week 52
Percentage of Participants With Complete Remission (CR) at Week 26
Tidsramme: Week 26
Complete Remission (CR) was defined as disappearance of all evidence of disease. CR was assessed by central review based on scans done at Week 26.
Week 26
Duration of Response (DOR)
Tidsramme: From date of first documentation of overall response to first documentation of PD or to death due to any cause in absence of PD or up to Week 52
DOR was defined as the time (in months) from date of the first documentation of overall response (CR or PR) to the first documentation of progressive disease (PD) based on central review or to death due to any cause in the absence of documented PD. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measureable disease and no new sites. PD was defined as any new lesion or increase by >=50% of previously involved sites from nadir. DOR was calculated using Kaplan-Meier method.
From date of first documentation of overall response to first documentation of PD or to death due to any cause in absence of PD or up to Week 52
Overall Survival
Tidsramme: From randomization until death due to any cause or up to Week 52
Overall survival was defined as the time (in months) from date of randomization to death due to any cause. For participants who were alive, overall survival was censored at the last contact. Overall survival was calculated using Kaplan-Meier method.
From randomization until death due to any cause or up to Week 52
Maximum Observed Serum Concentration (Cmax) of PF-05280586 and Rituximab-EU
Tidsramme: 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
Tidsramme: Predose (within 4 hours prior to the start of dosing) on Day 1, 8, 15, and 22
Predose (within 4 hours prior to the start of dosing) on Day 1, 8, 15, and 22
Cluster of Differentiation (CD) 19-Positive B-Cell Counts
Tidsramme: Baseline, Week 2, 3, 4, 5, 13, 26, 39, 52
Baseline, Week 2, 3, 4, 5, 13, 26, 39, 52
Number of Participants With Positive Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs)
Tidsramme: Baseline up to Week 52
Human serum ADA samples were analyzed for the presence or absence of anti-rituximab antibodies or anti-PF-05280586 antibodies using the validated drug-specific assay with a tiered approach using screening, confirmation and titer/quantitation. Human NAb serum samples testing ADA positive were analyzed for the presence or absence of neutralizing anti-rituximab antibody and neutralizing anti-PF-05280586 antibody using the validated drug-specific assay with a tiered approach using screening, confirmation and titer/quantitation. Participants with their ADA titer >= 1.88 were considered to be ADA positive. Only participants with a positive ADA result were further tested for NAb.
Baseline up to Week 52
Number of Participants Reporting Immune-Based Adverse Effects
Tidsramme: Baseline up to Week 52
Immune-based adverse effects included infusion related reaction (IRR), adverse events which fulfill Sampson's criteria, and adverse events which belong to the Standardized Medical Dictionary for Regulatory Activities (MedDRA) Queries (SMQs) anaphylaxis or hypersensitivity reactions. Potential allergic and anaphylactic reactions were identified programmatically based on the criteria of Sampson et al, (2006).
Baseline up to Week 52

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pfizer

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

30. september 2014

Primær færdiggørelse (Faktiske)

23. oktober 2017

Studieafslutning (Faktiske)

19. april 2018

Datoer for studieregistrering

Først indsendt

7. august 2014

Først indsendt, der opfyldte QC-kriterier

7. august 2014

Først opslået (Skøn)

11. august 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. juni 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. juni 2019

Sidst verificeret

1. juni 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • B3281006
  • 2014-000132-41 (EudraCT nummer)
  • REFLECTIONS (Anden identifikator: Alias Study Number)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ja

IPD-planbeskrivelse

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.

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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