Diffuse Large B-cell Lymphoma Clinical Trial
Official title:
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
Primary Objective:
Participants achieving an Objective Response Rate
Secondary Objective:
- Progression Free Survival
- Overall Survival
- Response Duration
- Safety
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.
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