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

Phase 2

Completed

• Conditions: Diffuse Large B-cell Lymphoma
• Interventions: Drug: SAR3419

• 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.

Study Timeline

• Study First Submitted: 2011-11-14
• Study First Submitted QC: 2011-11-14
• Study First Posted: 2011-11-17
• Study Start: 2012-01
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2018-01
• Disposition First Submitted: 2018-01-18
• Disposition First Submitted QC: 2018-01-18
• Last Update Submitted: 2018-01-18
• Disposition First Posted: 2018-01-25
• Last Update Posted: 2018-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

Not provided

Exclusion Criteria

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 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

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