Spots Global Cancer Trial Database for Combination of SAR3419 and Rituximab in Relapsed/Refractory Diffuse Large B-Cell Lymphoma
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Trial Identification
Brief Title: Combination of SAR3419 and Rituximab in Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Official Title: An Open Label, Multicenter Phase II Study of Intravenous SAR3419, an Anti-CD19 Antibody-Maytansine Conjugate, in Combination With Rituximab in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphomas
Study ID: NCT01470456
Conditions
Study Description
Brief Summary: Primary Objective: Participants Achieving an Objective Response Rate (Cheson 2007) Secondary Objectives: * Progression Free Survival * Overall Survival * Response Duration
Detailed Description: * The screening period = up to 4 weeks prior to the first administration of combined therapy * The treatment period = 3 months of combined therapy. A safety follow-up of 42 to 49 days after the last dose of treatment is planned for all patients. * The follow-up period: Patients who are not progressing at the end of study treatment will be followed until progression or initiation of another anti-lymphoma therapy. All patients will be followed for two years to evaluate survival.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Investigational Site Number 040002, Graz, , Austria
Investigational Site Number 250004, Creteil Cedex, , France
Investigational Site Number 250009, Dijon, , France
Investigational Site Number 250006, Lille Cedex, , France
Investigational Site Number 250011, Marseille Cedex 9, , France
Investigational Site Number 250010, Montpellier, , France
Investigational Site Number 250008, Nantes Cedex 01, , France
Investigational Site Number 250007, Paris Cedex 10, , France
Investigational Site Number 250001, Pierre Benite Cedex, , France
Investigational Site Number 250005, Rennes, , France
Investigational Site Number 250003, Rouen Cedex, , France
Investigational Site Number 250002, Villejuif Cedex, , France
Investigational Site Number 578001, Oslo, , Norway
Contact Details
Name: Clinical Sciences & Operations
Affiliation: Sanofi
Role: STUDY_DIRECTOR
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