A Phase 2 interventional study of SAR3419 in Diffuse Large B-cell Lymphoma, sponsored by Sanofi. Completed at 28 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-25.
Sponsored by Sanofi · Phase 2, Interventional, and Treatment
Primary Objective:
Participants achieving an Objective Response Rate
Secondary Objective:
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 61 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
All patients will receive SAR3419 until evidence of disease progression, unacceptable toxicity, or other reasons for therapy discontinuation
Drug: SAR3419
Pharmaceutical form:concentrate for solution for infusion Route of administration: intravenous
Number of participants achieving an Objective Response Rate
Time frame: 18 months
Number of participants with Adverse Events
Time frame: Up to 1 year
Response duration - Time
Time frame: Up to 18 months after the first infusion of the last patient
Progression Free Survival - Time
Time frame: Up to 18 months after the first infusion of the last patient
Overall Survival - Time
Time frame: Up to 18 months after the first infusion of the last patient
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Sanofi