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

Phase 1

• Conditions: Diffuse large B-cell lymphoma; MedDRA version: 14.1Level: PTClassification code 10012818Term: Diffuse large B-cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-003657-26-IT
• Lead Sponsor: SANOFI- AVENTIS RECHERCHE ET DÉVELOPPEMENT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-28
• Last Update Posted: 31 January 2017

Recruitment & Eligibility

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

Inclusion Criteria

• Histological diagnosis of Diffuse Large B Cell Lymphoma (de novo or transformed) based on recent (less than 3 months) or new biopsy, expressing CD19 by immunohistochemistry or flow cytometry analysis (at least or more than 30% positivity). • At least 1 and not more than 2 prior specific therapeutic regimens, one of which should have included rituximab • 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 3 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. • Signed written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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