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)
2019년 6월 18일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (실제)
394
단계
- 3단계
연락처 및 위치
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연구 장소
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Tbilisi, 그루지야, 0144
- High Technology Medical Center, University Clinic
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Tbilisi, 그루지야, 0112
- "LTD ""M. Zodelava's Hematology Centre"""
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Tbilisi, 그루지야, 0112
- LTD "Research Institute of Clinical Medicine"
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Athens, 그리스, 10676
- Gen. Hosp. of Athens "Evangelismos - Eye Hosp.- Polikliniki"
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Athens, 그리스, 10676
- Gen. Hosp. of Athens "Evangelismos-Eye Hosp. - Polikliniki"
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Athens, 그리스, 10676
- Gen. Hosp. of Athens "Evangelismos-Eye Hosp.-Polikliniki"
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Athens, 그리스, 10676
- Gen.Hosp.of Athens "Evangelismos-Eye Hosp.-polikiliniki"
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Athens, 그리스, 10676
- General Hospital of Athens "Evangelismos - Eye Hosp. - Polikliniki"
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Athens, 그리스, 11526
- Bioiatriki S.A.
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Athens, 그리스, 11526
- Bioiatriki
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Athens, 그리스, 11527
- General Hospital of Athens 'Laiko'
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Athens, 그리스, 12462
- """ATTIKON"" Gen. Univ. Hosp"
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Chaidari, Athens, 그리스, 12462
- "ATTIKON'' Gen. Univ. Hosp.
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Patras, 그리스, 26504
- University General Hospital of Patras
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Patras, 그리스, 26222
- Magnitiki Patron
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Gauteng
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Groenkloof, Gauteng, 남아프리카, 0181
- NIKSCH & PARTNERS t/a CAPITAL RADIOLOGY
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Johannesburg, Gauteng, 남아프리카, 2196
- The Medical Oncology Centre of Rosebank
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Pretoria, Gauteng, 남아프리카, 0002
- Department of Medical Oncology, University of Pretoria, Steve Biko Academic Hospitals Complex
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Pretoria, Gauteng, 남아프리카, 0044
- Albert Alberts Stem Cell Transplant Centre
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Pretoria, Gauteng, 남아프리카, 0044
- Dr JN De Jong and Partners t/a East Rad
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Pretoria, Gauteng, 남아프리카, 0181
- NIKSCH & PARTNERS t/a CAPITAL RADIOLOGY
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Rosebank, Gauteng, 남아프리카, 2196
- Drs Sulman & Partners Specialist Radiologists
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Sandton, Gauteng, 남아프리카, 2191
- Drs Bloch & Partners Incorporated
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Busan, 대한민국, 47392
- Inje University Busan Paik Hospital
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Seoul, 대한민국, 03080
- Seoul National University Hospital
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Seoul, 대한민국, 06351
- Samsung Medical Center
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Gyeonggi-do
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Anyang-si, Gyeonggi-do, 대한민국, 14068
- Hallym University Sacred Heart Hospital
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Seongnam-si, Gyeonggi-do, 대한민국, 463-707
- Seoul National University Bundang Hospital
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Jeollabuk-do
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Jeonju-si, Jeollabuk-do, 대한민국, 54907
- Chonbuk National University Hospital
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Korea
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Ulsan, Korea, 대한민국, 44033
- Ulsan University Hospital
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Berlin, 독일, 13353
- Charité - Universitätsmedizin Berlin
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Berlin, 독일, 12200
- Charite - Universitaetsmedizin Berlin
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Berlin, 독일, 12200
- Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin
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Berlin, 독일, 13353
- Charite - Universitaetsmedizin Berlin, Campus Virchow-Klinikum
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Berlin, 독일, 13353
- Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum
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Chemnitz, 독일, 09113
- Klinikum Chemnitz gGmbH
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Chemnitz, 독일, 09113
- Klinikum Chemnitz gGmbH - Institut fuer Interventionelle Radiologie und Neuroradiologie
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Chemnitz, 독일, 09116
- Klinikum Chemnitz gGmbH - Klinik fuer Nuklearmedizin
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Chemnitz, 독일, 09116
- Klinikum Chemnitz gGmbH - Zentralapotheke
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Essen, 독일, 45147
- Universitaetsklinikum Essen (AoeR)
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Essen, 독일, 45147
- Universitatsklinikum Essen (Aor)
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Herne, 독일, 44623
- DokuSan Gesellschaft fuer Medizinische Studien mbH & Co. KG
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Herne, 독일, 44649
- Apotheke des St. Anna Hospital
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Herne, 독일, 44651
- EVK Eickel
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Koeln, 독일, 50679
- Praxis im Koeln Triangle
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Mutlangen, 독일, 73557
- Gemeinschaftspraxis fuer Diagnostische Radiologie und Nuklearmedizin
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Mutlangen, 독일, 73557
- Kliniken Ostalb, Stauferklinikum Schwaebisch Gmuend, Zentrum fuer Innere Medizin
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Mutlangen, 독일, 73557
- Stauferklinikum Schwaebisch Gmuend, Apotheke
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Rostock, 독일, 18057
- Universitaetsmedizin Rostock
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Stuttgart, 독일, 70174
- Klinikum Stuttgart, Klinik fuer Nuklearmedizin
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Stuttgart, 독일, 70199
- Vinzenz von Paul Kliniken GgmbH
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Troisdorf, 독일, 53840
- Radiologie Rhein-Sieg
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Troisdorf, 독일, 53840
- Ueberoertliche Berufsausuebungsgemeinschaft Drs. med. Helmut Forstbauer
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Troisdorf, 독일, 53842
- Zentralapotheke
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Chelyabinsk, 러시아 연방, 454087
- "State Budget Healthcare Institution ""Chelyabinsk Regional Clinical Center of Oncology
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Moscow, 러시아 연방, 121309
- LLC "Vitamed"
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Moscow, 러시아 연방, 115478
- FSBSI 'N.N.Blokhin Russian Cancer Research Center' of MoH of RF
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Moscow, 러시아 연방, 115478
- Russian Cancer Research Centre them N.N. Blokhin
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Moscow, 러시아 연방, 125284
- SBHI of Moscow City Clinical Hospital n.a. S.P.Botkin of Healthcare Department of Moscow
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Moscow, 러시아 연방, 127473
- Ramsay Diagnostics
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Saint Petersburg, 러시아 연방, 194291
- State Budgetary Institution of Healthcare "Leningrad Regional Clinical Hospital"
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Saint-Petersburg, 러시아 연방, 194214
- Dr. Berezin Medical Institute
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Saint-Petersburg, 러시아 연방, 197376
- N.P. Bechtereva Institute of Human Brain of the Russian Academy of Sciences
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Saint-Petersburg, 러시아 연방, 197376
- N.P. Bechtereva Institute of the Human Brain of the Russian Academy of Sciences
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Saint-Petersurg, 러시아 연방, 195271
- Non-state healthcare institution "Road Clinical Hospital of Joint Stock Company "Russian Railways"
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Yaroslavl, 러시아 연방, 150010
- Yaroslavl State Medical Academy
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Yaroslavl, 러시아 연방, 150062
- GBUZ of Yaroslavl Region "Regional Clinical Hospital"
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Kaluga Region
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Obninsk, Kaluga Region, 러시아 연방, 249036
- A.Tsyb Medical Radiological Research Centre -
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Mordovian Republic
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Saransk, Mordovian Republic, 러시아 연방, 430032
- State Healthcare Institution Republican Oncology Dispensary
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Nizhniy Novgorod Region
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Nizhniy Novgorod, Nizhniy Novgorod Region, 러시아 연방, 603126
- "SBHI of NNR ""Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko"""
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Nizhniy Novgorod, Nizhniy Novgorod Region, 러시아 연방, 603126
- LLC MC "MRT-Diagnostika"
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Pesochniy
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Saint-Petersburg, Pesochniy, 러시아 연방, 197758
- FSBI "Russian Research Centre of Radiology and Surgical Technologies n.a. A.M. Granov" of MoH of RF
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Saint-Petersburg, Pesochniy, 러시아 연방, 197758
- FSBI "Russian Research Centre of Radiology and Surgical Technologies named after academician
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Saint-Petersburg, Pesochniy, 러시아 연방, 197758
- FSBI "Russian Research Centre of Radiology and Surgical Technologies
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Pesochniy TOWN
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Saint-Petersburg, Pesochniy TOWN, 러시아 연방, 197758
- FSBI "Russian Research Centre of Radiology and Surgical Technologies" of MoH of RF
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Saint-Petersburg, Pesochniy TOWN, 러시아 연방, 197758
- FSBI "Russian Research Centre of Radiology and Surgical Technologies"
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Saint-Petersburg, Pesochniy TOWN, 러시아 연방, 197758
- FSBI "Russian Research Centre of Radiology and Surgical Technologies
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Saint-Petersburg, Pesochniy TOWN, 러시아 연방, 197758
- FSBI 'Russian Research Centre of Radiology and Surgical Technologies
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Pos.pesochny
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Saint-Petersburg, Pos.pesochny, 러시아 연방, 197758
- FSBI 'National Medical Oncology Research Centre n.a. N.N.Petrov'
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Republic Bashkortostan
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Ufa, Republic Bashkortostan, 러시아 연방, 450054
- Branch office of LLC 'PET-Technology' at Ufa city
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Ufa, Republic Bashkortostan, 러시아 연방, 450054
- State Budgetary Healthcare Institution "Republican Clinical Oncology Dispensary of the Ministry
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Saint Petersburg
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Pushkin, Saint Petersburg, 러시아 연방, 196603
- Private Medical Institution "Euromedservice"
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Saint-petersburg
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Pesochniy Town, Saint-petersburg, 러시아 연방, 197758
- FSBI "Russian Research Centre of Radiology and Surgical Technologies" of MoH of RF
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Stavropol Region
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Lermontov, Stavropol Region, 러시아 연방, 357340
- Federal State-Financed Institution 'North-Caucasian Research and Clinical Center'
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Pyatigorsk, Stavropol Region, 러시아 연방, 357502
- SBHI of Stavropol Region "Pyatigorsk Interdistrict Oncology Dispensary
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Beirut, 레바논
- Doctors Center Radiology
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Beirut, 레바논
- Mount Lebanon Hospital
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El Metn, 레바논
- Middle East Institute Of Health
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Mount Lebanon, 레바논
- Ain Wazein Hospital
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Southern Governate
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Saida, Southern Governate, 레바논
- Hammoud Hospital, University Medical Center
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Brasov, 루마니아, 500152
- Policlinica de Diagnostic Rapid, Hematologie
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Brasov, 루마니아, 500366
- Policlinica de Diagnostic Rapid SA
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Bucuresti, 루마니아, 030171
- Spitalul Clinic Coltea, Clinica de Hematologie
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Bucuresti, 루마니아, 020125
- Spitalul Clinic Colentina
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Bucuresti, 루마니아, 021675
- Hiperdia Ritmului
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Bucuresti, 루마니아, 022328
- Affidea Fundeni
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Bucuresti, 루마니아, 022328
- Affidea Romania SRL
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Cluj-Napoca, 루마니아, 400015
- Institutul Oncologic Prof. Dr. Ion Chiricuta, Laborator Radiologie si Imagistica Medicala
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Cluj-Napoca, 루마니아, 400015
- Institutul Oncologic Prof. Dr. Ion Chiricuta, Sectia Oncologie Medicala
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Cluj-Napoca, 루마니아, 400124
- Clinica de Hematologie-Institutul Oncologic, Prof. Dr. Ion Chiricuta
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Cluj-Napoca, 루마니아, 400489
- CT Clinic S.R.L.
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Oaxaca, 멕시코, 68000
- Oaxaca Site Management Organization S.C.
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Oaxaca, 멕시코, 68000
- Cirurgia y Ginecobstetricia de Oaxaca, S.A de C.V.
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Puebla, 멕시코, 72190
- Hospital Angeles Puebla
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Queretaro, 멕시코, 76090
- Cancerologia de Queretaro S.C.
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Queretaro, 멕시코, 76140
- Hospital Infantil Teleton de Oncologia
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Queretaro, 멕시코, 76158
- Hospital San Jose Norte
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Distrito Federal
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Mexico City, Distrito Federal, 멕시코, 03310
- Grupo Médico Camino S.C.
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Mexico City, Distrito Federal, 멕시코, 03340
- Imagenus
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Mexico City, Distrito Federal, 멕시코, 06700
- Isos Pharmacorp, S.A. de C.V.
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Estado DE Mexico
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Cuautitlan Izacalli, Estado DE Mexico, 멕시코, 54750
- Vely Grupo Medico Quirurgico, S.A. de C.V.
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Cuautitlan Izcalli, Estado DE Mexico, 멕시코, 54769
- Phylasis Clinicas Research S. de R.L. de C.V.
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Nuevo LEON
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Monterrey, Nuevo LEON, 멕시코, 64460
- Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
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Monterrey, Nuevo LEON, 멕시코, 64460
- Centro Universitario de Imagen Diagnostica, Radiologia e Imagen del Hospital Universitario
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California
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Anaheim, California, 미국, 92801
- Pacific Cancer Medical Center, Inc.
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Anaheim, California, 미국, 92801
- The Oncology Institute of Hope and Innovation
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Corona, California, 미국, 92879
- Compassionate Care Research Group, Inc., at Compassionate Cancer Care Medical Group, Inc.
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Downey, California, 미국, 90241
- The Oncology Institute of Hope and Innovation
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Fountain Valley, California, 미국, 92708
- Compassionate Care Research Group, Inc., at Compassionate Cancer Care Medical Group, Inc.
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Gilroy, California, 미국, 95020
- Global Cancer Research Institute (GCRI), Inc
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Gilroy, California, 미국, 95020
- Saint Louise Regional Hospital Radiology Department (Radiology Only)
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Gilroy, California, 미국, 95020
- South Valley Imaging Center (Imaging Only)
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Glendale, California, 미국, 91204
- Los Angeles Hematology Oncology Medical Group
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Glendale, California, 미국, 91204
- The Oncology Institute of Hope and Innovation
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Glendale, California, 미국, 91206
- Los Angeles Hematology Oncology Medical Group
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Long Beach, California, 미국, 90805
- The Oncology Institute of Hope and Innovation
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Los Angeles, California, 미국, 90017
- Los Angeles Hematology Oncology Medical Group
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Los Angeles, California, 미국, 90057
- Los Angeles Hematology Oncology Medical Group
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Lynwood, California, 미국, 90262
- The Oncology Institute of Hope and Innovation
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Montebello, California, 미국, 90640
- The Oncology Institute of Hope and Innovation
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Palm Springs, California, 미국, 92262
- Comprehensive Cancer Center at Desert Regional Medical Center
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Redondo Beach, California, 미국, 90277
- Torrance Health Association DBA, Torrance Memorial Physician, Network/Cancer Care Associates
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Riverside, California, 미국, 92501
- Compassionate Care Research Group, Inc., at Compassionate Cancer Care Medical Group, Inc.
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San Jose, California, 미국, 95128
- O'Connor Hospital
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San Jose, California, 미국, 95124
- Global Cancer Research Institute, Inc.
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San Jose, California, 미국, 95128
- PET Imaging of San Jose (Imaging Only)
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Santa Ana, California, 미국, 92705
- The Oncology Institute of Hope and Innovation
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Torrance, California, 미국, 90505
- Torrance Memorial Medical Center
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Whittier, California, 미국, 90603
- Innovative Clinical Research Institute (ICRI)
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Whittier, California, 미국, 90602
- The Oncology Institute of Hope and Innovation
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Colorado
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Aurora, Colorado, 미국, 80012
- Rocky Mountain Cancer Centers
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Boulder, Colorado, 미국, 80303
- Rocky Mountain Cancer Centers
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Denver, Colorado, 미국, 80218
- Rocky Mountain Cancer Centers
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Lakewood, Colorado, 미국, 80228
- Rocky Mountain Cancer Center-Lakewood (Laboratory)
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Lakewood, Colorado, 미국, 80228
- Rocky Mountain Cancer Centers (RMCC) - Lakewood - St Anthony
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Lone Tree, Colorado, 미국, 80124
- Rocky Mountain Cancer Centers
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Pueblo, Colorado, 미국, 81008
- Rocky Mountain Cancer Center Pueblo
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Georgia
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Thomasville, Georgia, 미국, 31792
- John D. Archbold Memorial Hospital
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Thomasville, Georgia, 미국, 31792
- Lewis Hall Singletary Oncology Center at John D. Archbold Memorial Hospital
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Illinois
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DeKalb, Illinois, 미국, 60115
- Northwestern Medicine West Region
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Geneva, Illinois, 미국, 60134
- Cancer Center,Northwestern Medicine, West Region
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Kansas
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Chanute, Kansas, 미국, 66720
- Cancer Center of Kansas
-
Dodge City, Kansas, 미국, 67801
- Cancer Center of Kansas
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El Dorado, Kansas, 미국, 67042
- Cancer Center of Kansas
-
Independence, Kansas, 미국, 67301
- Cancer Center of Kansas
-
Kingman, Kansas, 미국, 67068
- Cancer Center of Kansas
-
Liberal, Kansas, 미국, 67905
- Cancer Center of Kansas
-
McPherson, Kansas, 미국, 67460
- Cancer Center of Kansas
-
Newton, Kansas, 미국, 67114
- Cancer Center of Kansas
-
Overland Park, Kansas, 미국, 66210
- The University of Kansas Cancer Center
-
Parsons, Kansas, 미국, 67357
- Cancer Center of Kansas
-
Salina, Kansas, 미국, 67401
- Cancer Center of Kansas
-
Wellington, Kansas, 미국, 67152
- Cancer Center of Kansas
-
Wichita, Kansas, 미국, 67214
- Cancer Center of Kansas
-
Wichita, Kansas, 미국, 67208
- Cancer Center of Kansas
-
Winfield, Kansas, 미국, 67156
- Cancer Center of Kansas
-
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Maryland
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Baltimore, Maryland, 미국, 21229
- Saint Agnes Hospital
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Baltimore, Maryland, 미국, 21229
- PET/CT facility Seton Imaging Center
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Bethesda, Maryland, 미국, 20817
- Rcca Md Llc
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Silver Spring, Maryland, 미국, 20910
- Holy Cross Hospital
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Silver Spring, Maryland, 미국, 20902
- Holy Cross Hospital Resource Center
-
Silver Spring, Maryland, 미국, 20910
- Holy Cross Hospital Hospital Pharmacy
-
Wheaton, Maryland, 미국, 20902
- Maryland Oncology Hematology, P.A.
-
-
Missouri
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Kansas City, Missouri, 미국, 64131
- The University of Kansas Cancer Center
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Kansas City, Missouri, 미국, 64154
- The University of Kansas Cancer Center
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Lee's Summit, Missouri, 미국, 64064
- The University of Kansas Cancer Center
-
-
Nebraska
-
Grand Island, Nebraska, 미국, 68803
- Saint Francis Medical Center, Saint Francis Cancer Treatment Center
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Grand Island, Nebraska, 미국, 68803
- Saint Francis Medical Center
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Hastings, Nebraska, 미국, 68901
- Saint Francis Medical Center, Saint Francis Cancer Treatment Center
-
-
Nevada
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Henderson, Nevada, 미국, 89074
- Comprehensive Cancer Centers of Nevada
-
Henderson, Nevada, 미국, 89052
- Comprehensive Cancer Centers of Nevada
-
Las Vegas, Nevada, 미국, 89148
- Comprehensive Cancer Centers of Nevada
-
Las Vegas, Nevada, 미국, 89128
- Comprehensive Cancer Centers of Nevada
-
Las Vegas, Nevada, 미국, 89169
- Comprehensive Cancer Centers of Nevada
-
-
North Carolina
-
Greenville, North Carolina, 미국, 27834
- Vidant Medical Center
-
Greenville, North Carolina, 미국, 27834
- Brody School of Medicine at East Carolina University
-
Greenville, North Carolina, 미국, 27834
- Vidant Medical Center Pharmacy
-
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Ohio
-
Maumee, Ohio, 미국, 43537
- Toledo Clinic Cancer Center - Maumee
-
Toledo, Ohio, 미국, 43623
- Toledo Clinic Cancer Center - Toledo
-
Toledo, Ohio, 미국, 43623
- Toledo Clinic, Inc.
-
-
Oregon
-
Eugene, Oregon, 미국, 97401
- Willamette Valley Cancer Institute and Research Center
-
-
Tennessee
-
Knoxville, Tennessee, 미국, 37920
- University of Tennessee Medical Center
-
-
Texas
-
Fort Sam Houston, Texas, 미국, 78234
- San Antonio Military Medical Center
-
Fort Sam Houston, Texas, 미국, 78234
- San Antonio Military Medical Center- Department of Pharmacy
-
Fort Sam Houston, Texas, 미국, 78234
- San Antonio Military Medical Center- Department of Radiology
-
Fort Worth, Texas, 미국, 76177
- Investigational Products Center (IPC)
-
Fort Worth, Texas, 미국, 76177
- Investigational Products Center (I PC)
-
Houston, Texas, 미국, 77090
- Millennium Oncology
-
Irving, Texas, 미국, 75063
- US Oncology Investigational Products Center (IPC)
-
Kingwood, Texas, 미국, 77339
- Millennium Oncology
-
Longview, Texas, 미국, 75601
- Texas Oncology - Longview Cancer Center
-
Shenandoah, Texas, 미국, 77384
- Millennium Oncology
-
The Woodlands, Texas, 미국, 77380
- Millennium Oncology
-
Tyler, Texas, 미국, 75702
- Texas Oncology-Tyler
-
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Washington
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Yakima, Washington, 미국, 98902
- Yakima Valley Memorial Hospital/North Star Lodge Cancer Center
-
-
-
-
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Brussels, 벨기에, 1070
- Hopital Erasme
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Brussels, 벨기에, 1200
- Nuclear Medicine Department
-
Charleroi, 벨기에, 6000
- Grand Hopital de Charleroi-Site Notre-Dame
-
Charleroi, 벨기에, 6000
- PET/CT facility: Grand Hopital de Charleroi (GHdC) - site Notre-Dame
-
Charleroi, 벨기에, 6000
- Pharmacy Department: Grand Hopital de Charleroi (GHdC) - site Notre-Dame
-
La Louviere (Haine-Saint Paul), 벨기에, 7100
- Pharmacy Department, Centre Hospitalier De Jolimont - Lobbes
-
La Louviere (Haine-Saint-Paul), 벨기에, 7100
- Centre Hospitalier de Jolimont - Lobbes
-
La Louviere (Haine-Saint-Paul), 벨기에, 7100
- Radiology Department
-
Mons, 벨기에, 7000
- C.H.U. Ambroise Paré
-
Mons, 벨기에, 7000
- Pharmacy Department, CHU Ambroise Pare
-
-
-
-
-
Brest, 벨라루스, 224027
- Healthcare Institution "Brest Regional Oncologic Dispensary"
-
Minsk, 벨라루스, 220013
- Healthcare Institution 'Minsk City Clinical Oncology Dispensary'
-
Republic Of Belarus, 벨라루스, 223040
- SI Republican Research and Practice Centre of oncology and medical radiology n.a N.N Alexandrov
-
-
Minsk Region
-
Lesnoy, Minsk Region, 벨라루스, 220013
- SI 'Republican Research and Practice Centre of Oncology and Medical Radiology n.a. N.N. Alexandrov'
-
Lesnoy, Minsk Region, 벨라루스, 223040
- SI 'Republican Research and Practice Centre of Oncology and Medical Radiology n.a. N.N. Alexandrov'
-
-
-
-
-
Sao Paulo, 브라질, 01236-030
- IEP Sao Lucas - Instituto de Ensino e Pesquisa Sao Lucas / HEMOMED - Instituto de Oncologia e
-
Sao Paulo, 브라질, 01333-910
- Fleury
-
-
Bahia
-
Salvador, Bahia, 브라질, 40050-410
- Hospital Santa Izabel - Setor de Bioimagem
-
Salvador, Bahia, 브라질, 40050-410
- Hospital Santa Izabel / Santa Casa de Misericordia da Bahia
-
-
GO
-
Goiania, GO, 브라질, 74175-150
- Clinica Multimagem
-
Goiania, GO, 브라질, 74605-020
- Hospital das Clinicas da Universidade Federal de Goias \ Centro de Pesquisa Clinica
-
-
MG
-
Belo Horizonte, MG, 브라질, 30130-100
- Centro de Imagens da Faculdade de Medicina - INCT Medicina Nuclear - PET/CT
-
Belo Horizonte, MG, 브라질, 30130-100
- Unidade Funcional Apoio Diagnostico e terapeutica por Imagem do HC/UFMG - CT Scan
-
-
Minas Gerais
-
Belo Horizonte, Minas Gerais, 브라질, 30130-100
- Hospital das Clinicas Universidade Federal de Minas Gerais
-
-
RIO Grande DO SUL
-
Porto Alegre, RIO Grande DO SUL, 브라질, 90035-903
- Hospital de Clinicas de Porto Alegre
-
Porto Alegre, RIO Grande DO SUL, 브라질, 90035-903
- Central de Misturas Intravenosas do Hospital de Clinicas de Porto Alegre
-
Porto Alegre, RIO Grande DO SUL, 브라질, 90035-903
- Hospital de Clinicas de Porto Alegre - Centro de Pesquisa Clinica
-
Porto Alegre, RIO Grande DO SUL, 브라질, 90035-903
- Servico de Radiologia do Hospital de Clinicas de Porto Alegre
-
-
RS
-
Porto Alegre, RS, 브라질, 90610-000
- CDI - Centro de Diagnostico por Imagem do Hospital Sao Lucas da PUCRS
-
Porto Alegre, RS, 브라질, 90610-000
- InsCer - Instituto do Cerebro do Rio Grande do Sul - PUCRS
-
Porto Alegre, RS, 브라질, 90610-000
- Uniao Brasileira de Educacao e Assistencia (UBEA) - Hospital Sao Lucas da PUCRS -
-
-
SAO Paulo
-
Jau, SAO Paulo, 브라질, 17210-080
- Fundacao Amaral Carvalho / Fundacao Dr. Amaral Carvalho
-
Jau, SAO Paulo, 브라질, 17210-120
- Fundacao Amaral Carvalho / Fundacao Dr. Amaral Carvalho
-
Jaú, SAO Paulo, 브라질, 17210-120
- Unidade de Quimioterapia
-
Santo Andre, SAO Paulo, 브라질, 09030-340
- Casa da Esperanca
-
Sao Bernardo do Campo, SAO Paulo, 브라질, 09750-670
- TECNOLAB
-
-
SP
-
Campinas, SP, 브라질, 13075-460
- CEMEDI
-
Campinas, SP, 브라질, 13075-460
- Instituto Radium
-
Campinas, SP, 브라질, 13087-567
- CAEP - Centro Avancado de Estudos e Pesquisas LTDA
-
Campinas, SP, 브라질, 13087-567
- Hospital e Maternidade Madre Theodora LTDA
-
Campinas, SP, 브라질, 13092-132
- CENNI Oncologia
-
Santo Andre, SP, 브라질, 09060-650
- Fundacao do ABC - FMABC/ Faculdade de Medicina ABC ( CEPHO - Centro de Estudos e Pesquisas de
-
Sao Paulo, SP, 브라질, 01506-000
- Hospital Bandeirantes
-
Sao Paulo, SP, 브라질, 05403-000
- Hospital das Clinicas da Faculdade de Medicina da USP / Fundacao Faculdade de Medicina MEC MPAS
-
Sao Paulo, SP, 브라질, 08270-070
- Casa de Saude Santa Marcelina (Centro de Pesquisa Santa Marcelina)
-
São Paulo, SP, 브라질, 01242-020
- IEP São Lucas (Pharmacy)
-
-
-
-
-
Basel, 스위스, 4031
- Universitätsspital Basel
-
Bern, 스위스, 3010
- Inselspital Bern
-
Thun, 스위스, 3600
- Apotheke, Spital STS AG
-
Thun, 스위스, 3600
- Onkologiezentrum Thun-Berner Oberland Spital Sts Ag
-
Zuerich, 스위스, 8091
- Universitaetsspital Zuerich
-
Zuerich, 스위스, 8006
- Kantonsapotheke Zuerich
-
-
-
-
-
A Coruna, 스페인, 15006
- Complejo Hospitalario Universitario A Coruña
-
A Coruna, 스페인, 15011
- Hospital Modelo
-
Barcelona, 스페인, 08003
- Hospital Del Mar
-
Barcelona, 스페인, 08012
- Hospital Quiron de Barcelona, IEC
-
Barcelona, 스페인, 08029
- CETIR, Centre Medic
-
Barcelona, 스페인, 08029
- Radiodiagnostic CETIR - Clinica del Pilar
-
Cadiz, 스페인, 11009
- Hospital Universitario Puerta del Mar
-
Madrid, 스페인, 28040
- Hospital Universitario Fundación Jiménez Díaz
-
Madrid, 스페인, 28050
- Hospital Universitario Sanitas La Moraleja
-
Malaga, 스페인, 29010
- Hospital Universitario Virgen de la Victoria
-
Malaga, 스페인, 29010
- Centro CIMES
-
Malaga, 스페인, 29016
- Centro Mario Gallegos
-
Ourense, 스페인, 32005
- Complejo Hospitalario de Ourense. Hematología
-
Sevilla, 스페인, 41013
- Hospital Universitario Virgen del Rocío
-
Zaragoza, 스페인, 50012
- Hospital de Dia Quiron Zaragoza
-
Zaragoza, 스페인, 50006
- H. Quirón Zaragoza
-
-
Barcelona
-
Sabadell, Barcelona, 스페인, 08208
- Hospital Parc Tauli
-
-
Guipuzcoa
-
San Sebastian, Guipuzcoa, 스페인, 20014
- Onkologikoa
-
-
Madrid
-
Aravaca, Madrid, 스페인, 28023
- Hospital Universitario Sanitas la Zarzuela
-
Mostoles, Madrid, 스페인, 28933
- Hospital Rey Juan Carlos
-
-
Murcia
-
El Palmar, Murcia, 스페인, 30120
- Hospital Clínico Universitario Virgen de la Arrixaca
-
-
Pontevedra
-
Vigo, Pontevedra, 스페인, 36200
- Hospital do Meixoeiro Complejo Hospitalario Universitario de Vigo
-
-
-
-
-
Bath, 영국, BA1 3NG
- Royal United Hospitals Bath NHS Foundation Trust
-
London, 영국, EC1A 7BE
- Barts Health NHS Trust
-
Newcastle upon Tyne, 영국, NE4 6BE
- Positron Emission Tomography (PET) Centre
-
Sunderland, 영국, SR4 7TP
- City Hospitals Sunderland NHS Foundation Trust-Sunderland Royal Hospital
-
Sunderland, 영국, SR4 7TP
- Diagnostic Imaging
-
-
Essex
-
Westcliff-On-Sea, Essex, 영국, SS0 0RY
- Southend University Hospital NHS Foundation Trust
-
-
Glos.
-
Cheltenham, Glos., 영국, GL53 7AS
- Cobalt Diagnostic Imaging
-
-
-
-
-
Linz, 오스트리아, 4010
- Krankenhaus Der Barmherzigen Schwestern Linz
-
Linz, 오스트리아, 4020
- Kepler Universitaetsklinikum GmbH
-
Linz, 오스트리아, 4021
- Kepler Universitaetsklinikum GmbH
-
-
-
-
-
Chernivtsi, 우크라이나, 58013
- "Municipal Institution ""Chernivtsi Regional Clinical Oncology Center"",
-
Dnipropetrovsk, 우크라이나, 49102
- MI 'City Dnipropetrovsk Multi-field Clin. Hospital #4 of DRC',
-
Kharkiv, 우크라이나, 61070
- Municipal Non-Profit Enterprise "Regional Oncology Centre"
-
Kyiv, 우크라이나, 03022
- National Cancer Institute
-
Uzhhorod, 우크라이나, 88017
- "Central City Clinical Hospital, City Oncology Center, SHEI ""Uzhhorod National University"", Chair
-
Vinnytsia, 우크라이나, 21029
- Podilskyy Regional Oncology Center, Chemotherapy Department
-
Zaporizhzhia, 우크라이나, 69040
- Municipal Establishment 'Zaporizhzhia Regional Clinical Oncology Dispensary'
-
Zaporizhzhia, 우크라이나, 69076
- LLC "Diaservis"
-
-
KYIV Region
-
Obukhiv, KYIV Region, 우크라이나, 08720
- "MedX-Ray International Group" LLC
-
Obukhiv District, KYIV Region, 우크라이나, 08720
- "Mediks-rey International Group" LLC
-
Obukhiv District, KYIV Region, 우크라이나, 08720
- "MedX-rey International Group" LLC
-
-
-
-
-
Genova, 이탈리아, 16132
- IRCSS A.O.U. San Martino - IST - UO Clinica Ematologica
-
Milano, 이탈리아, 20133
- SC Ematologia, Fondazione IRCCS Ist Nazionale dei Tumori
-
Parma, 이탈리아, 43100
- Padiglione 1, Torre delle medicine, 6 piano
-
Pesaro, 이탈리아, 61122
- Ematologia e Centro Trapianti - AZ Osp. Ospedali Riuniti Marche Nord (AORMN) - Presidio S. Salvatore
-
Pisa, 이탈리아, 56126
- U.O. Ematologia Universitaria - Dip. Di Oncologia dei Trapianti - AOU Pisana
-
Roma, 이탈리아, 00128
- Policlinico Universitario Campus Bio- Medico-U.O.C. di Ematologia Trapianto Cellule Staminali
-
-
CR
-
Cremona, CR, 이탈리아, 26100
- U.O. di Ematologia e CTMO - Istituti Ospedalieri di Cremona
-
-
FC
-
Meldola, FC, 이탈리아, 47014
- IRST - IRCCS U. O. Oncologia Medica
-
-
GE
-
Genova, GE, 이탈리아, 16132
- U.O. Ematologia 1 - IRCCS AOU San Martino-IST
-
-
MB
-
Monza, MB, 이탈리아, 20900
- Unita di Ricerca Clinica
-
-
MI
-
Milano, MI, 이탈리아, 20141
- Istituto Europeo di Oncologia
-
-
NAP
-
Latina, NAP, 이탈리아, 04100
- Unità semplice di Medicina Nucleare
-
-
PG
-
Terni, PG, 이탈리아, 05100
- Az Ospedaliera Santa Maria
-
-
Palermo
-
Torrette Ancona, Palermo, 이탈리아, 60121
- Clinica Ematologica - A.O.U. Ospedali Riuniti di Ancona
-
-
Reggio
-
Reggio Emilia, Reggio, 이탈리아, 42123
- Medicina nucleare
-
Reggio Emilia, Reggio, 이탈리아, 42123
- Radiologia
-
Reggio Emilia, Reggio, 이탈리아, 42123
- SC Ematologia - SC Ematologia - Arcispedale Santa Maria Nuova - IRCCS
-
-
Rome Rm
-
Rome, Rome Rm, 이탈리아, 00161
- "Dipartimento di Biotecnologie Cellulari ed Ematologia, Universita ""Sapienza""
-
-
-
-
-
New Delhi, 인도, 110 085
- Rajiv Gandhi Cancer Institute & Research Center (RGCIRC)
-
-
Gujarat
-
Surat, Gujarat, 인도, 395001
- Super Scan Imaging Centre
-
Surat, Gujarat, 인도, 395002
- Pathology Department, Unique Hospital Multispeciality & Research Institute
-
Surat, Gujarat, 인도, 395002
- Zircon- BIC Imaging Centre
-
-
Karanataka
-
Mangalore, Karanataka, 인도, 575002
- Mangalore Institute of Oncology
-
-
Karnataka
-
Bangalore, Karnataka, 인도, 560027
- HealthCare Global Enterprises Limited
-
Manipal, Karnataka, 인도, 576104
- Kasturba Medical College and Hospital
-
-
Maharashtra
-
Nashik, Maharashtra, 인도, 422004
- Curie Manavata Cancer Centre
-
Nashik, Maharashtra, 인도, 422004
- Department of Radiology, Curie Manavata Cancer Centre
-
Pune, Maharashtra, 인도, 411001
- Ruby Hall Clinic
-
Pune, Maharashtra, 인도, 411001
- Department of Radiology
-
Pune, Maharashtra, 인도, 411001
- Jehangir Clinical Development Centre Pvt. Ltd.
-
-
Rajasthan
-
Jaipur, Rajasthan, 인도, 302004
- R.K. Birla Cancer Center, Sawai Man Singh Hospital
-
-
Tamilnadu
-
Chennai, Tamilnadu, 인도, 600035
- Apollo Speciality Hospital
-
Chennai, Tamilnadu, 인도, 600035
- Department of Radiology
-
-
Telangana
-
Hyderabad, Telangana, 인도, 500 004
- Global Hospitals
-
Hyderabad, Telangana, 인도, 500029
- Vijaya Diagnostic Centre
-
-
WEST Bengal
-
Kolkata, WEST Bengal, 인도, 700014
- N.R.S Medical College and Hospital
-
Kolkata, WEST Bengal, 인도, 700014
- Spandan PET-CT Unit
-
-
-
-
-
Fukuoka, 일본, 811-0213
- Fukuoka Wajiro PET Diagnostic Imaging Clinic
-
Nagano, 일본, 399-8701
- National Hospital Organization Matsumoto Medical Center
-
Tokyo, 일본, 2080022
- Musashimurayama Hospital
-
-
Aichi
-
Nagoya, Aichi, 일본, 466-8650
- Nagoya Daini Red Cross Hospital
-
Nagoya, Aichi, 일본, 464-0044
- East Nagoya Imaging Diagnosis Center
-
-
Akita
-
Akita City, Akita, 일본, 010-8543
- Akita University Hospital
-
-
Chiba
-
Chiba-shi, Chiba, 일본, 260-8717
- Chiba Cancer Center
-
-
Fukuoka
-
Fukuoka-Shi, Fukuoka, 일본, 811-1395
- National Hospital Organization Kyushu Cancer Center
-
Fukuoka-shi, Fukuoka, 일본, 810-8563
- National Hospital Organization Kyushu Medical Center
-
-
Hyogo
-
Kobe-City, Hyogo, 일본, 650-0047
- Kobe City Medical Center General Hospital
-
-
Ishikawa
-
Kanazawa, Ishikawa, 일본, 920-8650
- National Hospital Organization Kanazawa Medical Center
-
Kanazawa, Ishikawa, 일본, 9200934
- Kanazawa Advanced Medical Center
-
-
Kanagawa-ken
-
Yokohama-shi, Kanagawa-ken, 일본, 224-8503
- Showa University Northern Yokohama Hospital
-
-
Kochi
-
Okocho, Nankoku, Kochi, 일본, 783-8505
- Kochi Medical School Hospital
-
-
Kumamoto-ken
-
Kumamoto-shi, Kumamoto-ken, 일본, 860-0008
- National Hospital Organization Kumamoto Medical Center
-
Kumamoto-shi, Kumamoto-ken, 일본, 862-0941
- Uozumi Clinic
-
-
Miyagi
-
Sendai-shi, Miyagi, 일본, 983-8520
- National Hospital Organization Sendai Medical Center
-
Sendai-shi, Miyagi, 일본, 980-0873
- Sendai Kousei Hospital
-
-
Nagano
-
Matsumoto-shi, Nagano, 일본, 390-8510
- Aizawa Hospital
-
Nagano-shi, Nagano, 일본, 380-8582
- Nagano Red Cross Hospital
-
-
Nagasaki
-
Omura, Nagasaki, 일본, 856-8562
- National Hospital Organization Nagasaki Medical Center
-
-
Osaka
-
Kawachinagano, Osaka, 일본, 586-8521
- National Hospital Organization Osaka Minami Medical Center
-
Naka-ku Sakai, Osaka, 일본, 599-8271
- Hanwa Dai 2 Senboku Hospital
-
Osaka-City, Osaka, 일본, 545-8586
- Osaka City University Hospital
-
-
Tokushima
-
Tokushima-Shi, Tokushima, 일본, 770-8503
- Tokushima University Hospital
-
-
Tokyo
-
Meguro-Ku, Tokyo, 일본, 152-8902
- National Hospital Organization Tokyo Medical Center
-
Shinagawa-ku, Tokyo, 일본, 142-8666
- Showa University Hospital
-
Tachikawa, Tokyo, 일본, 190-0014
- National Hospital Organization Disaster Medical Center
-
-
Yamagata
-
Yamagata-Shi, Yamagata, 일본, 990-9585
- Yamagata University Hospital
-
-
-
-
-
Ankara, 칠면조, 06100
- Hacettepe Universitesi Tip Fakultesi Onkoloji Hastanesi
-
Ankara, 칠면조, 06200
- Dr. Abdurrahman Yurtaslan Ankara Onkoloji Eg. ve Aras.
-
Ankara, 칠면조, 06420
- Ultramar Tibbi Gorunteleme Merkezi
-
Ankara, 칠면조, 06420
- Ultramar Tibbi Goruntuleme Merkezi
-
Ankara, 칠면조, 06540
- Integra Gurses Teshis Tedavi ve Saglik Hizmetleri A.S.
-
Aydin, 칠면조, 09010
- Adnan Menderes University Medical Faculty
-
Gaziantep, 칠면조, 27310
- Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi
-
Gaziantep, 칠면조, 27310
- Gaziantep Universitesi Sahinbey Arastirma ve Uygulama
-
Istanbul, 칠면조, 34093
- Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
-
Izmir, 칠면조, 35040
- Ege Universitesi Tip Fakultesi Ic Hastaliklari Anabilim Dali
-
Izmir, 칠면조, 35040
- EGE-RAD Bilgisayarli Tomografi Ozel Saglik Hizmetleri ve Malzemeleri Tic.Ltd.Sti.
-
Kayseri, 칠면조, 38100
- Erciyes Universitesi Tip Fakultesi Nukleer Tip Laboratuvari
-
Kayseri, 칠면조, 38100
- Erciyes Universitesi Tip Fakultesi Radyoloji Laboratuvari
-
Kayseri, 칠면조, 38100
- Erciyes Universitesi Tip Fakultesi
-
Malatya, 칠면조, 44280
- Inonu Universitesi Tip Fakultesi Turgut Ozal Tip Merkezi
-
Manisa, 칠면조, 45000
- Celal Bayar University Medical Faculty
-
Samsun, 칠면조, 55139
- Ondokuz Mayis Universitesi Tip Fakultesi
-
-
-
-
-
Zagreb, 크로아티아, 10000
- University Hospital Centre Zagreb
-
Zagreb, 크로아티아, 10 000
- University Hospital Center Zagreb, Department of Nuclear Medicine and Radiation Protection
-
Zagreb, 크로아티아, 10 000
- University Hospital Center Zagreb, Department of Pathology and Cytology
-
Zagreb, 크로아티아, 10 000
- University Hospital Center Zagreb, Department of Radiology
-
Zagreb, 크로아티아, 10000
- University Hospital Centre "Sestre Milosrdnice"
-
-
-
-
-
Bangkok, 태국, 10400
- National Cancer Institute
-
Bangkok, 태국, 10400
- Cardiology Unit,Department of Medicine, Faculty of Medicine, Ramathibodi Hospital,
-
Bangkok, 태국, 10400
- Department of Radiology, Ramathibodi Hospital
-
-
-
-
-
Lima, 페루, 18
- Pet Scan Peru
-
Lima, 페루, 18
- Resocentro
-
-
Lima
-
Surquillo, Lima, 페루, 34
- Instituto Nacional de Enfermedades Neoplasicas
-
-
-
-
-
Braga, 포르투갈, 4710-243
- Hospital de Braga
-
Lisboa, 포르투갈, 1998-018
- Hospital CUF Descobertas
-
Porto, 포르투갈, 4050-075
- CIMC
-
Porto, 포르투갈, 4050-075
- Dr. Campos Costa Clinic
-
Porto, 포르투갈, 4099 - 001
- Centro Hospitalar do Porto-Hospital de Santo Antonio E.P.E.
-
Porto, 포르투갈, 4200-072
- Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E
-
Vila Nova de Gaia, 포르투갈, 4434-502
- Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
-
-
Porto
-
Matosinhos, Porto, 포르투갈, 4464-513
- Unidade Local de Saude de Matosinhos E.P.E. - Hospital Pedro Hispano S.A.
-
-
-
-
-
Warszawa, 폴란드, 02-781
- Klinika Nowotworow Ukladu Chlonnego Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie
-
Wroclaw, 폴란드, 50-420
- Euromedic Wroclawskie Centrum Medyczne II
-
Wroclaw, 폴란드, 50-557
- Euromedic Wroclawskie Centrum Medyczne III
-
Wroclaw, 폴란드, 53-439
- Dolnośląskie Centrum Transplantacji Komórkowych z Krajowym Bankiem Dawców Szpiku
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Wroclaw, 폴란드, 53-439
- Euromedic Wroclawskie Centrum Medyczne I
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Wroclaw, 폴란드, 54-424
- Apteka Dolnoslaskiego Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku
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Coto Laurel, 푸에르토 리코, 00780
- Modern Radiology, PSC
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Ponce, 푸에르토 리코, 00717
- Ad-Vance Medical Research, LLC
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Ponce, 푸에르토 리코, 00717
- Caribe MRI and CT
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Boulogne Sur Mer, 프랑스, 62321
- Hopital Duchenne Chu - Boulogne Sur Mer
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Bourg En Bresse Cedex, 프랑스, 01012
- Centre Hospitalier de Bourg en Bresse
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Brest, 프랑스, 29609
- Hopital Morvan-CHU Brest- Service Hematologie Clinique
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Caen, 프랑스, 14033
- Centre Hospitalier Universitaire Côte de Nacre
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Le Mans, 프랑스, 72037
- Centre Hospitalier du Mans
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Lyon, 프랑스, 69009
- Clinique de la Sauvegarde
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Marseille Cedex 05
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Marseille, Marseille Cedex 05, 프랑스, 13385
- CHU Marseille Hopital de La Conception
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Mulhouse Cedex
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Mulhouse, Mulhouse Cedex, 프랑스, 68100
- CH de Mulhouse, Hopital Emile Muller
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NAP
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Boulogne Sur Mer, NAP, 프랑스, 62321
- Hopital Duchenne Chu - Boulogne Sur Mer
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Quezon City, 필리핀 제도, 1102
- St. Luke's Medical Center
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Metro Manila
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Manila, Metro Manila, 필리핀 제도, 1000
- University of Philippines Manila-Philippine General Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: PF-05280586
|
PF-05280586 (rituximab-Pfizer) concentrate for solution for infusion 375mg/m2 administered via IV infusion on Days 1, 8, 15, and 22
|
|
활성 비교기: 맙테라®
|
MabThera® (rituximab-EU) concentrate for solution for infusion 375mg/m2 administered via IV infusion on Days 1, 8, 15, and 22
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Overall Response Rate (ORR): Percentage of Participants With Overall Response (OR) at Week 26
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
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Time to Treatment Failure (TTF)
기간: 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)
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2014년 9월 30일
기본 완료 (실제)
2017년 10월 23일
연구 완료 (실제)
2018년 4월 19일
연구 등록 날짜
최초 제출
2014년 8월 7일
QC 기준을 충족하는 최초 제출
2014년 8월 7일
처음 게시됨 (추정)
2014년 8월 11일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 6월 20일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 6월 18일
마지막으로 확인됨
2019년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- B3281006
- 2014-000132-41 (EudraCT 번호)
- REFLECTIONS (기타 식별자: Alias Study Number)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
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.
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .