Combination of SAR3419 and rituximab in relapsed/refractory Diffuse Large B Cell Lymphoma
- Conditions
- Diffuse large B-cell lymphomaMedDRA version: 15.0Level: 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
- EUCTR2011-002865-39-DE
- Lead Sponsor
- sanofi-aventis recherche et développement
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Histologically diagnosis of DLBCL
- Relapsed or refractory after at least one standard treatment including rituximab
- CD19 and CD20 positive disease
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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
Exclusion Criteria
- No bi-dimensionally measurable lesion by CT scan (defined as presence of at least one tumor mass measuring >1.5 x 1.5 cm)
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 (Cheson 2007);Secondary Objective: Safety,<br>Progression Free survival, Overall Survival, Response Duration;Primary end point(s): Objective Response Rate;Timepoint(s) of evaluation of this end point: 18 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Safety<br>- Response Duration<br>- Progression Free Survival<br>- Overall survival;Timepoint(s) of evaluation of this end point: - Safety : treatment period<br>- Response Duration : up to 24 months after the first<br>infusion of the last patient<br>- Progression Free Survival : up to 24 months after the first<br>infusion of the last patient<br>- Overall survival : up to 24 months after the first<br>infusion of the last patient<br>