272
Participants
Start Date
May 31, 2013
Primary Completion Date
May 31, 2016
Study Completion Date
July 31, 2017
RTXM83
Rituximab biosimilar (RTXM83) will be administered in combination with CHOP chemotherapy regimen (Cyclophosphamide 750 mg/m2, Doxorubicin 50 mg/m2 and Vincristine 1.4 mg/m2 up to a maximum of 2 mg on Day 1 plus Prednisone 40 mg/m2 or 100 mg per day from Day 1 to 5) at a dose of 375 mg/m2 on Day 1 of each 3 week cycle, for 6 cycles, although the administration of 2 additional cycles may be allowed.
Mabthera
Mabthera will be administered in combination with CHOP chemotherapy regimen (Cyclophosphamide 750 mg/m2, Doxorubicin 50 mg/m2 and Vincristine 1.4 mg/m2 up to a maximum of 2 mg on Day 1 plus Prednisone 40 mg/m2 or 100 mg per day from Day 1 to 5) at a dose of 375 mg/m2 on Day 1 of each 3 week cycle, for 6 cycles, although the administration of 2 additional cycles may be allowed.
Mount Miriam Cancer Hospital, Pulau Pinang
University Malaya Medical Centre - UMMC, Kuala Lumpur
"Hosp. Interzonal R Carrillo", Ciudadela
Clinica Radiologica del Sur, Cipolletti
Clinica Viedma, Viedma
Hospital Britanico, Buenos Aires
Hospital Gral. de Agudos Donación Francisco Santojanni, Buenos Aires
Instituto Roffo, Buenos Aires
Centro Oncologico Riojano Integral (CORI), Córdoba
Hospital Nacional de Clinicas, Córdoba
Hospital Privado de Cordoba, Córdoba
Sanatorio Allende, Córdoba
Ctr. Oncologico de Rosario, Rosario
Inst. Cardiovascular Rosario, Rosario
Instituto de Hematología y Medicina Clínica Dr. Rubén Dávoli, Rosario
Sanatorio Parque, Rosario
Hospital Angel Padilla, San Miguel de Tucumán
Fundación ARS Médica, San Salvador de Jujuy
Hospital J. B. Iturraspe, Santa Fe
Hospital de Caridade de Ijuí, Ijuí
Hospital da Cidade de Passo Fundo, Passo Fundo
Hospital São Lucas da PUCRS, Porto Alegre
Hospital Clinicas Porto Alegre, Pôrto Alegre
Hospital Santa Marcelina, Itaquera
Hospital Amaral Carvalho Jaú, Jaú
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo-HCFMRP, Ribeirão Preto
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia / Faculdade de Medicina do ABC, Santo André
Fundação Antônio Prudente - AC Camargo Câncer Center, São Paulo
Hospital das Clinicas-UFMG, Belo Horizonte
UNICAMP-Univ Zeferino Vaz, Campinas
Hospital Uniao Oeste Paranaense de Estudos e Comabte ao Cancer (UOPECCAN), Cascavel
Hospital Erasto Gaertner CEPEP, Curitiba
Hospital das Clínicas da Universidade Federal de Goiás, Goiânia
Santa Casa de Porto Alegre, Porto Alegre
Hospital Universitário Clemente Fraga Filho - UFRJ, Rio de Janeiro
Instituto COI de Educação e Pesquisa, Rio de Janeiro
Instituto Est. de Hematologia Arthur de Siqueira Cavalcanti, Rio de Janeiro
Monte Tabor - Hospital São Rafael, Salvador
Hospital de Base de São José, São José do Vale do Rio Preto
Centro de Pesquisa do Instituto Brasileiro de Controle do Câncer - IBCC, São Paulo
Hospital Clinica Faculdade Medicina USP, São Paulo
Inst. Nacional de Cancerologia, Bogotá
Hospital Pablo Tobon Uribe, Medellín
Fundación Valle de Lili, Santiago de Cali
Srinivasam Cancer Care Hospital, Bangalore
Cancer Institute, Chennai
Rajiv Gandhi Cancer Institute and Research Centre, Delhi
Bibi General Hospital&Canc Ct, Hyderabad
Birla Cancer Center - SMS Hospital, Jaipur
Health Point Multi-specialty Hospital, Kolkata
Institute of Hematology and Transfusion Medicine, Kolkata
Netaji Subhash Chandra Bose Cancer Research Institute, Kolkata
Acharya Tulsi Regional Cancer Treatment and Research Institute, Madurai
Guru Hospital, Madurai
Meenakshi Mission Hospital, Madurai
Kailash Cancer Hospital and Research Centre, Vadodara
Dr. Hasan Sadikin Hospital, Bandung
Dharmais N. C. Center, Jakarta
Imam Khomeini Complex Hospital - Cancer Institute, Tehrān
Hospital Sultanah Aminah, Johor Bahru
Hospital Pulau Pinang, Pulau Pinang
Insituto Nacional de Cancerología, Mexico City
Instituto Privado de Hematologia e Investigaciona Clinica, Asunción
Cebu Doctors University Hospital, Cebu
Perpetual Succour Hospital, Cebu
Davao Doctors Hospital, Davao City
National Kidney and Transplant Institute, Quezon City
Veterans Memorial Medical Center, Quezon City
Arkhangelsk Clinical Oncology Dispensary, Arkhangelsk
Kursk regional clinical oncology dispensary, Kursk
N.N. Blokhin Russian Cancer Research Cente, Moscow
National Medical Surgical Center n.a. N.I. Pirogov, Moscow
Murmansk regional oncology dispensary, Murmansk
"State Budgetary Healthcare Institution of Stavropol region Pyatigorsk oncology center", Pyatigorsk
Rostov Scientific Research Oncology Institute, Rostov-on-Don
Russian Research Center for Radiology and Surgical Technologies, Saint Petersburg
"Saint-Petersburg State Budgetary Institution City Clinical Oncology Dispensary", Saint Petersburg
Scientific Research Institute of Oncology n.a. N.N. Petrov, Saint Petersburg
Oncology Center # 2, Sochi
Komi Republican Oncology Dispensary, Syktyvkar
"State Healthcare Institution of Tula region Tula regional clinical hospital", Tula
Republican Clinical Oncology Dispensary, Ufa
Volgograd Regional Clinical Oncology Center, Volgograd
Tygerberg Academic Hosp, Cape Town
Rainbow Oncology Centre, eManzimtoti
GVI Oncology, Port Elizabeth
Chris Hani Baragwanath Hospital, Soweto
Pisa® Farmacéutica
UNKNOWN
Laboratorios de Productos Éticos C.E.I.S.A.
UNKNOWN
Laboratorio Elea Phoenix S.A.
INDUSTRY
Tecnoquimicas S.A
UNKNOWN
Innogene Kalbiotech Pte. Ltd
INDUSTRY
Libbs Farmacêutica LTDA
INDUSTRY
Key Oncologics (Pty) Ltd
UNKNOWN
Nanolek LLC
OTHER
Actoverco
OTHER
mAbxience Research S.L.
INDUSTRY