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
Overview
- Phase
- Phase 2
- Intervention
- SAR3419
- Conditions
- Diffuse Large B-cell Lymphoma
- Sponsor
- Sanofi
- Enrollment
- 61
- Locations
- 28
- Primary Endpoint
- Number of participants achieving an Objective Response Rate
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
SAR3419
All patients will receive SAR3419 until evidence of disease progression, unacceptable toxicity, or other reasons for therapy discontinuation
Intervention: SAR3419
Outcomes
Primary Outcomes
Number of participants achieving an Objective Response Rate
Time Frame: 18 months
Secondary Outcomes
- 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)