Diffuse Large B-cell Lymphoma
Conditions
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.
Interventions
DRUGSAR3419
Pharmaceutical form:concentrate for solution for infusion Route of administration: intravenous
Sponsors
Sanofi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histological diagnosis of Diffuse Large B Cell Lymphoma (de novo or transformed) expressing CD19 by immunohistochemistry or flow cytometry analysis (\>30% positivity), based on recent (less than 6 months) or new biopsy. * At least 1 prior specific therapeutic regimen, one of which should have included rituximab (patients previously eligible for transplantation: the salvage treatment followed by intensification and Autologous Stem Cell Transplant (ASCT) will be considered one regimen). * Relapsed disease after standard 1st line therapy for aggressive lymphoma - not eligible for high dose chemotherapy with stem cell support. Relapsed or refractory disease after two lines of therapy one of which could have included Autologous Stem Cell Transplant (ASCT). Relapsed disease is defined as progression after a disease free interval of at least 6 months after completion of last therapy. Refractory is defined as progression of disease during prior therapy or within 6 months from its completion. * Available paraffin-embedded tissue should have been collected no longer than 6 months prior to first administration of SAR3419. Cryo-preserved tissue cannot be used. If archival material is not available, a Fine Needle Aspiration (FNA) must be obtained.
Exclusion criteria
* Primary refractory patients * Patients with primary mediastinal DLBCL The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants achieving an Objective Response Rate | 18 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Progression Free Survival - 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 |
Countries
Belgium, Czechia, Israel, Italy, Poland, Spain, Turkey (Türkiye), United Kingdom, United States
Outcome results
None listed