SAR3419 as Single Agent in Relapsed-Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Patients

Completed · Phase 2

Conditions studied: Diffuse Large B-cell Lymphoma

In brief

Primary Objective: Participants achieving an Objective Response Rate Secondary Objective: * Progression Free Survival * Overall Survival * Response Duration * Safety

Key facts

Study ID

NCT01472887

Run by

Sanofi

People needed

61

Starts

2012-01-01

Expected to finish

2016-09-01

Last updated by the study team

2018-01-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Investigational Site Number 840001 — Denver, Colorado, United States
• Investigational Site Number 840003 — Augusta, Georgia, United States
• Investigational Site Number 840005 — Boise, Idaho, United States
• Investigational Site Number 056002 — Ghent, Belgium
• Investigational Site Number 056001 — Leuven, Belgium
• Investigational Site Number 203002 — Brno, Czechia
• Investigational Site Number 203003 — Prague, Czechia
• Investigational Site Number 203001 — Prague, Czechia
• Investigational Site Number 376003 — Jerusalem, Israel
• Investigational Site Number 376002 — Tel Litwinsky, Israel
• Investigational Site Number 380002 — Bergamo, Italy
• Investigational Site Number 380004 — Bologna, Italy
• Investigational Site Number 380008 — Mestre, Italy
• Investigational Site Number 380001 — Milan, Italy
• Investigational Site Number 380007 — Modena, Italy
• Investigational Site Number 380003 — Palermo, Italy
• Investigational Site Number 380006 — Pavia, Italy
• Investigational Site Number 616003 — Brzozów, Poland
• Investigational Site Number 616002 — Kielce, Poland
• Investigational Site Number 616001 — Warsaw, Poland
• Investigational Site Number 724002 — Barcelona, Spain
• Investigational Site Number 724004 — Barcelona, Spain
• Investigational Site Number 724001 — Madrid, Spain
• Investigational Site Number 724003 — Valencia, Spain
• Investigational Site Number 792003 — Izmir, Turkey (Türkiye)

Full record on ClinicalTrials.gov

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