An Open Label, Multicenter Phase II Study of Intravenous SAR3419, an Anti-CD19 Antibody-Maytansine Conjugate, in Combination With Rituximab in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphomas
18 Years
N/A
Both
Diffuse Large B-Cell Lymphoma
Trial Information
An Open Label, Multicenter Phase II Study of Intravenous SAR3419, an Anti-CD19 Antibody-Maytansine Conjugate, in Combination With Rituximab in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphomas
- 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 dose of treatment is planned for all patients.
- The follow-up period: Patients who are not progressing at the end of study treatment
will be followed until progression or initiation of another anti-lymphoma therapy. All
patients will be followed for two years to evaluate survival.
Inclusion Criteria
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of participants achieving an Objective Response Rate
Outcome Time Frame:
18 weeks
Safety Issue:
No
Principal Investigator
Clinical Sciences & Operations
Investigator Role:
Study Director
Investigator Affiliation:
Sanofi
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
TCD12333
NCT ID:
NCT01470456
Start Date:
November 2011
Completion Date:
March 2015
Related Keywords:
- Diffuse Large B-Cell Lymphoma
- Lymphoma
- Lymphoma, B-Cell
- Lymphoma, Large B-Cell, Diffuse
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