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
๐บ๐ธAugusta, Georgia, United States
Investigational Site Number 056002
๐ง๐ชGent, Belgium
Investigational Site Number 203002
๐จ๐ฟBrno, Czechia
Investigational Site Number 203003
๐จ๐ฟPraha 10, Czechia
Investigational Site Number 203001
๐จ๐ฟPraha 2, Czechia
Investigational Site Number 380007
๐ฎ๐นModena, Italy
Investigational Site Number 724002
๐ช๐ธBarcelona, Spain
Investigational Site Number 724004
๐ช๐ธBarcelona, Spain
Investigational Site Number 724001
๐ช๐ธMadrid, Spain
Investigational Site Number 724003
๐ช๐ธValencia, Spain
Investigational Site Number 826001
๐ฌ๐งLeicester, United Kingdom
Investigational Site Number 826002
๐ฌ๐งManchester, United Kingdom
Investigational Site Number 840005
๐บ๐ธBoise, Idaho, United States
Investigational Site Number 056001
๐ง๐ชLeuven, Belgium
Investigational Site Number 380008
๐ฎ๐นMestre, Italy
Investigational Site Number 376003
๐ฎ๐ฑJerusalem, Israel
Investigational Site Number 376002
๐ฎ๐ฑTel Hashomer, Israel
Investigational Site Number 380002
๐ฎ๐นBergamo, Italy
Investigational Site Number 380004
๐ฎ๐นBologna, Italy
Investigational Site Number 380001
๐ฎ๐นMilano, Italy
Investigational Site Number 380003
๐ฎ๐นPalermo, Italy
Investigational Site Number 380006
๐ฎ๐นPavia, Italy
Investigational Site Number 616003
๐ต๐ฑBrzozow, Poland
Investigational Site Number 616002
๐ต๐ฑKielce, Poland
Investigational Site Number 616001
๐ต๐ฑWarszawa, Poland
Investigational Site Number 792003
๐น๐ทIzmir, Turkey
Investigational Site Number 792001
๐น๐ทIzmir, Turkey
Investigational Site Number 840001
๐บ๐ธDenver, Colorado, United States