SAR3419 as Single Agent in Relapsed-Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Patients
- Registration Number
- NCT01472887
- Lead Sponsor
- Sanofi
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 61
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SAR3419 SAR3419 All patients will receive SAR3419 until evidence of disease progression, unacceptable toxicity, or other reasons for therapy discontinuation
- Primary Outcome Measures
Name Time Method Number of participants achieving an Objective Response Rate 18 months
- Secondary Outcome Measures
Name Time Method Number of participants with Adverse Events Up to 1 year Response duration - Time Up to 18 months after the first infusion of the last patient Overall Survival - Time Up to 18 months after the first infusion of the last patient Progression Free Survival - Time Up to 18 months after the first infusion of the last patient
Trial Locations
- Locations (28)
Investigational Site Number 840003
🇺🇸Augusta, Georgia, United States
Investigational Site Number 056002
🇧🇪Gent, Belgium
Investigational Site Number 203002
🇨🇿Brno, Czechia
Investigational Site Number 203003
🇨🇿Praha 10, Czechia
Investigational Site Number 203001
🇨🇿Praha 2, Czechia
Investigational Site Number 380007
🇮🇹Modena, Italy
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 826001
🇬🇧Leicester, United Kingdom
Investigational Site Number 826002
🇬🇧Manchester, United Kingdom
Investigational Site Number 840005
🇺🇸Boise, Idaho, United States
Investigational Site Number 056001
🇧🇪Leuven, Belgium
Investigational Site Number 380008
🇮🇹Mestre, Italy
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 380001
🇮🇹Milano, 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 792003
🇹🇷Izmir, Turkey
Investigational Site Number 792001
🇹🇷Izmir, Turkey
Investigational Site Number 840001
🇺🇸Denver, Colorado, United States