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

Sponsor
Sanofi
Study ID
NCT01470456
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SAR3419 — DRUG
    Pharmaceutical form:solution for infusion Route of administration: Intravenous
  • rituximab — DRUG
    Pharmaceutical form:solution for infusion Route of administration: intravenous

Study Details

Primary Objective: Participants Achieving an Objective Response Rate (Cheson 2007) Secondary Objectives: * Progression Free Survival * Overall Survival * Response Duration

Key Dates

Start date
Nov 30, 2011
Status verified
Nov 2014
Primary completion
Jul 31, 2013
Completion
Sep 30, 2014

Study Design

Enrollment
50 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SAR3419 + Rituximab
    Combined therapy will be administered intravenously for 8 doses in the absence of unacceptable toxicity, disease progression or withdrawal of consent.

Primary Outcome Measure

Number of participants achieving an Objective Response Rate [ Time Frame: 18 weeks ]

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