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Spots Global Cancer Trial Database for SAR3419 as Single Agent in Relapsed-Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Patients

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Trial Identification

Brief Title: SAR3419 as Single Agent in Relapsed-Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Patients

Official Title: An Open Label Non-Randomized Phase 2 Study Evaluating SAR3419, an Anti-CD19 Antibody - Maytansine Conjugate, Administered as Single Agent by Intravenous Infusion to Patients With Relapsed or Refractory CD19+ Diffuse Large B-Cell Lymphoma

Study ID: NCT01472887

Interventions

SAR3419

Study Description

Brief Summary: Primary Objective: Participants achieving an Objective Response Rate Secondary Objective: * Progression Free Survival * Overall Survival * Response Duration * Safety

Detailed Description: The screening period = up to 4 weeks prior to SAR3419 administration The treatment period = from the day of first administration of SAR3419 until the End-Of-Treatment visit. All patients will receive SAR3419 until evidence of disease progression, unacceptable toxicity or other reasons for therapy discontinuation - After therapy discontinuation all patients will enter a safety follow-up period of 42 days starting from the day of administration of the last dose of SAR3419 and ending with the End Of Treatment visit. All patients, regardless whether they have progressed or not, will be followed until death or end of study to evaluate survival for at least 18 months.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Investigational Site Number 840001, Denver, Colorado, United States

Investigational Site Number 840003, Augusta, Georgia, United States

Investigational Site Number 840005, Boise, Idaho, United States

Investigational Site Number 056002, Gent, , Belgium

Investigational Site Number 056001, Leuven, , Belgium

Investigational Site Number 203002, Brno, , Czechia

Investigational Site Number 203003, Praha 10, , Czechia

Investigational Site Number 203001, Praha 2, , Czechia

Investigational Site Number 376003, Jerusalem, , Israel

Investigational Site Number 376002, Tel Hashomer, , Israel

Investigational Site Number 380002, Bergamo, , Italy

Investigational Site Number 380004, Bologna, , Italy

Investigational Site Number 380008, Mestre, , Italy

Investigational Site Number 380001, Milano, , Italy

Investigational Site Number 380007, Modena, , Italy

Investigational Site Number 380003, Palermo, , Italy

Investigational Site Number 380006, Pavia, , Italy

Investigational Site Number 616003, Brzozow, , Poland

Investigational Site Number 616002, Kielce, , Poland

Investigational Site Number 616001, Warszawa, , Poland

Investigational Site Number 724002, Barcelona, , Spain

Investigational Site Number 724004, Barcelona, , Spain

Investigational Site Number 724001, Madrid, , Spain

Investigational Site Number 724003, Valencia, , Spain

Investigational Site Number 792003, Izmir, , Turkey

Investigational Site Number 792001, Izmir, , Turkey

Investigational Site Number 826001, Leicester, , United Kingdom

Investigational Site Number 826002, Manchester, , United Kingdom

Contact Details

Name: Clinical Sciences & Operations

Affiliation: Sanofi

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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