SAR3419 as Single Agent in Relapsed-Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Patients

Overview

Primary Objective: Participants achieving an Objective Response Rate Secondary Objective: – Progression Free Survival – Overall Survival – Response Duration – Safety

Full Title of Study: “An Open Label Non-Randomized Phase 2 Study Evaluating SAR3419, an Anti-CD19 Antibody – Maytansine Conjugate, Administered as Single Agent by Intravenous Infusion to Patients With Relapsed or Refractory CD19+ Diffuse Large B-Cell Lymphoma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2016

Detailed Description

The screening period = up to 4 weeks prior to SAR3419 administration The treatment period = from the day of first administration of SAR3419 until the End-Of-Treatment visit. All patients will receive SAR3419 until evidence of disease progression, unacceptable toxicity or other reasons for therapy discontinuation – After therapy discontinuation all patients will enter a safety follow-up period of 42 days starting from the day of administration of the last dose of SAR3419 and ending with the End Of Treatment visit. All patients, regardless whether they have progressed or not, will be followed until death or end of study to evaluate survival for at least 18 months.

Interventions

  • Drug: SAR3419
    • Pharmaceutical form:concentrate for solution for infusion Route of administration: intravenous

Arms, Groups and Cohorts

  • Experimental: SAR3419
    • All patients will receive SAR3419 until evidence of disease progression, unacceptable toxicity, or other reasons for therapy discontinuation

Clinical Trial Outcome Measures

Primary Measures

  • Number of participants achieving an Objective Response Rate
    • Time Frame: 18 months

Secondary Measures

  • Number of participants with Adverse Events
    • Time Frame: Up to 1 year
  • Response duration – Time
    • Time Frame: Up to 18 months after the first infusion of the last patient
  • Progression Free Survival – Time
    • Time Frame: Up to 18 months after the first infusion of the last patient
  • Overall Survival – Time
    • Time Frame: Up to 18 months after the first infusion of the last patient

Participating in This Clinical Trial

Inclusion Criteria

  • Histological diagnosis of Diffuse Large B Cell Lymphoma (de novo or transformed) expressing CD19 by immunohistochemistry or flow cytometry analysis (>30% positivity), based on recent (less than 6 months) or new biopsy. – At least 1 prior specific therapeutic regimen, one of which should have included rituximab (patients previously eligible for transplantation: the salvage treatment followed by intensification and Autologous Stem Cell Transplant (ASCT) will be considered one regimen). – Relapsed disease after standard 1st line therapy for aggressive lymphoma – not eligible for high dose chemotherapy with stem cell support. Relapsed or refractory disease after two lines of therapy one of which could have included Autologous Stem Cell Transplant (ASCT). Relapsed disease is defined as progression after a disease free interval of at least 6 months after completion of last therapy. Refractory is defined as progression of disease during prior therapy or within 6 months from its completion. – Available paraffin-embedded tissue should have been collected no longer than 6 months prior to first administration of SAR3419. Cryo-preserved tissue cannot be used. If archival material is not available, a Fine Needle Aspiration (FNA) must be obtained. Exclusion criteria:

  • Primary refractory patients – Patients with primary mediastinal DLBCL The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sanofi
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Clinical Sciences & Operations, Study Director, Sanofi

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