Combination of SAR3419 and Rituximab in Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Sanofi

Status and phase: Completed; Phase 2

Conditions: Diffuse Large B-Cell Lymphoma

Treatments: Drug: SAR3419; Drug: rituximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01470456

2011-002865-39

TCD12333

U1111-1120-0315 (Other Identifier)

Details and patient eligibility

About

Primary Objective:

Participants Achieving an Objective Response Rate (Cheson 2007)

Secondary Objectives:

• Progression Free Survival
• Overall Survival
• Response Duration

Full 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 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

SAR3419 + Rituximab

Experimental group

Description:

Combined therapy will be administered intravenously for 8 doses in the absence of unacceptable toxicity, disease progression or withdrawal of consent.

Treatment:

Drug: SAR3419

Drug: rituximab