Trial Synopsis

Study of RTXM83 Plus CHOP Chemotherapy Versus a Rituximab
Plus CHOP Therapy in Patients With Non Hodgkin's Lymphoma
Status: Completed
Study Phase: Phase 3
Start Date: May 2013 | Completion Date: May 2016
Condition(s): Diffuse Large B-cell Lymphoma
Full Title of Study
A Randomized, Double-blind, Phase III Study Comparing Biosimilar Rituximab
(RTXM83) Plus CHOP Chemotherapy Versus a Reference Rituximab Plus CHOP (RCHOP) in Patients With Diffuse Large B-cell Lymphoma (DLBCL) Given as First Line
Overview
Study of RTXM83 plus CHOP chemotherapy versus a rituximab plus CHOP therapy in
patients with Non Hodgkin's lymphoma The primary endpoint of the investigation is
to determine if the response rate obtained with RXM83 combined with CHOP is non
inferior to the response rate obtained with reference rituximab combined with CHOP
The present study is a non inferiority trial and the study hypothesis is the following:
H0: pc ≥ pe + δ vs. H1: pc
Study Details
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study,
Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver,
Investigator), Primary Purpose: Treatment
Investigator Details
Lead Sponsor: mAbxience S.A
Collaborator: Pisa Farmacética
Collaborator
: Laboratorios de Productos Éticos C.E.I.S.A.
Collaborator: Laboratorio Elea S.A.C.I.F. y A.
Collaborator: Tecnoquímicas S.A.
Collaborator: Innogene Kalbiotech Pte. Ltd
Collaborator: Libbs Farmacêutica Ltda
Collaborator: Key Oncologics (Pty) Ltd
Collaborator: Nanolek LLC
Collaborator: Actoverco
Study Director: Susana Millán, Phd mAbxience S.A
Trial Location Details
Facility: Hosp. Interzonal "R" Carrillo Bariloche, Argentina
Facility: Hospital Britanico Buenos Aires, Argentina
Facility: Hospital de Vicente Lopez Buenos Aires, Argentina
Facility: Hospital Gral. de Agudos Donación Francisco Santojanni Buenos Aires, Argentina
Facility: Insituto Roffo Buenos Aires, Argentina
Facility: Centro Oncologico Riojano Integral (CORI) Cordoba, Argentina
Facility: Hospital Cordoba Cordoba, Argentina
Facility: Hospital Nacional de Clinicas Cordoba, Argentina
Facility: Hospital Privado de Cordoba Cordoba, Argentina
Facility: Sanatorio Allende Cordoba, Argentina
Facility: Fundación ARS Médica Jujuy, Argentina
Facility: Ctr. Oncologico San Peregrino Neuquen, Argentina
Facility: Clinica Radiologica del Sur Rio Negro, Argentina
Facility: Clinica Viedma Rio Negro, Argentina
Facility: Ctr. Oncologico de Rosario Rosario, Argentina
Facility: Inst. Cardiovascular Rosario Rosario, Argentina
Facility: Instituto de Hematología y Medicina Clínica Dr. Rubén Dávoli Rosario, Argentina
Facility: Sanatorio Parque Rosario, Argentina
Facility: Hospital J. B. Iturraspe Santa Fe, Argentina
Facility: Hospital Angel Padilla Tucumán, Argentina
Facility: Fundação Universidade de Caxias do Sul Caxias do Sul, Brazil
Facility: Hospital de Caridade de Ijuí Ijuí, Brazil
Facility: Hospital de Caridade de Passo Fundo Passo Fundo, Brazil
Facility: Hospital São Lucas da PUCRS Porto Alegre, Brazil
Facility: Hospital Santa Marcelina Itaquera, Brazil
Facility: Hospital Amaral Carvalho Jaú Jaú, Brazil
Facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da
Universidade de São Paulo-HCFMRP Ribeirão Preto, Brazil
Facility: CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia /
Faculdade de Medicina do ABC Santo André, Brazil
Facility: Fundação Antônio Prudente - AC Camargo Câncer Center Sao Paulo, Brazil
Facility: Hospital das Clinicas-UFMG Belo Horizonte, Brazil
Facility: UNICAMP-Univ Zeferino Vaz Campinas, Brazil
Facility: UOPECCAN Cascavel, Brazil
Facility: Hospital das Clinicas UFPR Curitiba, Brazil
Facility: Hospital Erasto Gaertner CEPEP Curitiba, Brazil
Facility: ISCMPA Porto Alegre, Brazil
Facility: COI Inst COI Educacao e Pesquisa Rio de Janeiro, Brazil
Facility: Inst Hemato de Siqueira Cavalcante Rio de Janeiro, Brazil
Facility: UFRJ Rio de Janeiro, Brazil
Facility: Hospital Clinicas Porto Alegre Rio Grande do Sul, Brazil
Facility: Hospital Sao Rafael Salvador, Brazil
Facility: Hosp. de Base SJRP Sao Jose do Rio Preto, Brazil
Facility: Centro de Estudos Hemocentro Sao Paulo, Brazil
Facility: Centro Pesquisa IBCC Sao Paulo, Brazil
Facility: Hospital Clinica Faculdade Medicina USP Sao Paulo, Brazil
Facility: Inst. Nacional de Cancerologia Bogotá, Colombia
Facility: Fundación Valle de Lili Cali, Colombia
Facility: Hospital Pablo Tobon Uribe Medellin, Colombia
Facility: Rajiv Gandhi Cancer Institute and Research Centre Delhi, India
Facility: Institute of Hematology and Transfusion Medicine Gujarat, India
Facility: Bibi General Hospital&Canc Ct Hyderabad, India
Facility: Srinivasam Cancer Care Hospital Karnataka, India
Facility: Health Pt Multi-specialty Hospital Kolkata, India
Facility: Netaji Subhash Chandra Bose Kolkata, India
Facility: Acharya Tulsi Regional Cancer Treatment and Research Institute Madurai, India
Facility: Kailash Cancer Hospital and Research Centre State of Rajasthan, India
Facility: Cancer Institute Tamil Nadu, India
Facility: Meenakshi Mission Hospital Tamil Nadu, India
Facility: Dr. Hasan Sadikin Hospital Bandung, Indonesia
Facility: Dharmais N. C. Center Jakarta, Indonesia
Facility: Cancer Institute Teheran, Iran, Islamic Republic of
Facility: Hospital Sultanah Aminah Johor Bahru, Malaysia
Facility: University Malaya Medical Centre Kuala Lumpur, Malaysia
Facility: Mount Miriam Cancer Hospital Penang, Malaysia
Facility: Hospital Pulau Pinang Pulau Pinang, Malaysia
Facility: Insituto Nacional de Cancerología Mexico DF, Mexico
Facility: Instituto Privado de Hematologia e Investigaciona Clinica Asunción, Paraguay
Facility: Cebu Doctors University Hospital Cebu, Philippines
Facility: Perpetual Succour Hospital Cebu, Philippines
Facility: Davao D. Hospital Davao, Philippines
Facility: National Kidney and Transplant Institute Quezon City, Philippines
Facility: Veterans Memorial Medical Center Quezon City, Philippines
Facility: Arkhangelsk Clinical Oncology Dispensary Arkhangelsk, Russian Federation
Facility: Regional State Budgetary Healthcare Institution "Altay Regional
Oncology Dispensary" Barnaul, Russian Federation
Facility: Kursk regional clinical oncology dispensary Kursk region, Russian Federation
Facility: N.N. Blokhin Russian Cancer Research Cente Moscow, Russian Federation
Facility: National Medical Surgical Center n.a. N.I. Pirogov Moscow, Russian Federation
Facility: Murmansk regional oncology dispensary Murmansk, Russian Federation
Facility: State Budgetary Healthcare Institution of Stavropol region "Pyatigorsk
oncology center" Pyatigorsk, Russian Federation
Facility: Rostov Scientific Research Oncology Institute Rostov-on-Don, Russian Federation
Facility: Russian Research Center for Radiology and Surgical Technologies SaintPetersburg, Russian Federation
Facility: Saint-Petersburg State Budgetary Institution "City Clinical Oncology
Dispensary" Saint-Petersburg, Russian Federation
Facility: Scientific Research Institute of Oncology n.a. N.N. Petrov Saint-Petersburg, Russian
Federation
Facility: Oncology Center # 2 Sochi, Russian Federation
Facility: Komi Republican Oncology Dispensary Syktyvkar, Russian Federation
Facility: State Healthcare Institution of Tula region "Tula regional clinical
hospital" Tula, Russian Federation
Facility: Republican Clinical Oncology Dispensary Ufa, Russian Federation
Facility: Volgograd Regional Clinical Oncology Center Volgograd, Russian Federation
Facility: Rainbow Oncology Amanzimtoti, South Africa
Facility: Tygerberg Academic Hosp Cape Town, South Africa
Facility: GVI Oncology Port Elizabeth, South Africa
Facility: Chris Hani Baragwanath Hospital Soweto, South Africa
Facility: Khon-Kaen University Khon-Kaen, Thailand
Interventions
Biological: 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.
Information Source
ID Number: RTXM83-AC-01-11
NCT Identifier: NCT02268045
Health Authority: Array
Full Source of Clinical Trial Data: https://clinicaltrials.gov/show/NCT02268045
ClinicalTrials.gov processed this data on September 29, 2016
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately
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