Status:
COMPLETED
Combination of SAR3419 and Rituximab in Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Lead Sponsor:
Sanofi
Conditions:
Diffuse Large B-Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Primary Objective: Participants Achieving an Objective Response Rate (Cheson 2007) Secondary Objectives: * Progression Free Survival * Overall Survival * Response Duration
Detailed Description
* The screening period = up to 4 weeks prior to the first administration of combined therapy * The treatment period = 3 months of combined therapy. A safety follow-up of 42 to 49 days after the last d...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Histological diagnosis of Diffuse Large B-Cell Lymphoma (DLBCL)
- Relapsed or refractory after at least one standard treatment including rituximab
- CD19 and CD20 positive disease
- 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)
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01470456
Start Date
November 1 2011
End Date
September 1 2014
Last Update
November 13 2014
Active Locations (13)
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1
Investigational Site Number 040002
Graz, Austria, 8036
2
Investigational Site Number 250004
Créteil, France, 94010
3
Investigational Site Number 250009
Dijon, France, 21000
4
Investigational Site Number 250006
Lille, France, 59037