Combination of SAR3419 and Rituximab in Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Phase 2

Completed

• Conditions: Diffuse Large B-Cell Lymphoma
• Interventions: Drug: SAR3419; Drug: rituximab

• Registration Number: NCT01470456
• Lead Sponsor: Sanofi

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.

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-09
• Study First Submitted QC: 2011-11-10
• Study First Posted: 2011-11-11
• Primary Completion: 2013-07
• Study Completion: 2014-09
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-12
• Last Update Posted: 2014-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SAR3419 + Rituximab	rituximab	Combined therapy will be administered intravenously for 8 doses in the absence of unacceptable toxicity, disease progression or withdrawal of consent.
SAR3419 + Rituximab	SAR3419	Combined therapy will be administered intravenously for 8 doses in the absence of unacceptable toxicity, disease progression or withdrawal of consent.

Primary Outcome Measures

Name	Time	Method
Number of participants achieving an Objective Response Rate	18 weeks

Secondary Outcome Measures

Name	Time	Method
Number of participants with Adverse Events	Up to 6 months
Response Duration -Time	Up to 24 months after the first infusion of the last patient
Overall survival -Time	Up to 24 months after the first infusion of the last patient
Progression Free Survival -Time	Up to 24 months after the first infusion of the last patient

Trial Locations

Locations (13)

Investigational Site Number 250006; 🇫🇷 Lille Cedex, France

Investigational Site Number 040002; 🇦🇹 Graz, Austria

Investigational Site Number 250004; 🇫🇷 Creteil Cedex, France

Investigational Site Number 250009; 🇫🇷 Dijon, France

Investigational Site Number 250011; 🇫🇷 Marseille Cedex 9, France

Investigational Site Number 250008; 🇫🇷 Nantes Cedex 01, France

Investigational Site Number 250007; 🇫🇷 Paris Cedex 10, France

Investigational Site Number 250005; 🇫🇷 Rennes, France

Investigational Site Number 250001; 🇫🇷 Pierre Benite Cedex, France

Investigational Site Number 250003; 🇫🇷 Rouen Cedex, France

Investigational Site Number 250002; 🇫🇷 Villejuif Cedex, France

Investigational Site Number 578001; 🇳🇴 Oslo, Norway

Investigational Site Number 250010; 🇫🇷 Montpellier, France