SAR3419 as single agent in relapsed-refractory diffuse large B-celllymphoma (DLBCL) patients

Phase 1

• Conditions: Diffuse large B-cell lymphoma; MedDRA version: 16.0Level: PTClassification code 10012818Term: Diffuse large B-cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-003657-26-BE
• Lead Sponsor: sanofi aventis recherche et développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-20
• Last Update Posted: 7 November 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• Histological diagnosis of DLBCL (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 regimens one of which should have included rituximab (patients previously eligible for transplantation: the salvage treatment followed by intensification and 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 study treatment infusion. Cryo-preserved tissue cannot be used. If archival material is not available, at least a Fine Needle Aspiration (FNA) must be obtained. Archival diagnosis biopsy may be used retrospectively as a complementary material for biomarkers analysis (Refer to section 9.5.1). If necessary, a specific informed consent will be signed.

• Signed written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 22
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 33

Exclusion Criteria

• Primary refractory patients
• Patients with primary mediastinal DLBCL

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Objective Response Rate;Secondary Objective: Safety, Response Duration, Progression Free Survival, Overall Survival;Primary end point(s): Objective Response Rate;Timepoint(s) of evaluation of this end point: 18 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Safety<br>Response Duration, Progression Free Survival, Overall Survival;Timepoint(s) of evaluation of this end point: Safety : treatment period<br>Response Duration, Progression Free Survival, Overall Survival : up to 18 months after the first infusion of the last patient