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

November 12, 2014 updated by: Sanofi

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

Primary Objective:

Participants Achieving an Objective Response Rate (Cheson 2007)

Secondary Objectives:

  • Progression Free Survival
  • Overall Survival
  • Response Duration

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Investigational Site Number 040002
  • France
      • Creteil Cedex, France, 94010
        • Investigational Site Number 250004
      • Dijon, France, 21000
        • Investigational Site Number 250009
      • Lille Cedex, France, 59037
        • Investigational Site Number 250006
      • Marseille Cedex 9, France, 13273
        • Investigational Site Number 250011
      • Montpellier, France, 34295
        • Investigational Site Number 250010
      • Nantes Cedex 01, France, 44093
        • Investigational Site Number 250008
      • Paris Cedex 10, France, 75475
        • Investigational Site Number 250007
      • Pierre Benite Cedex, France, 69495
        • Investigational Site Number 250001
      • Rennes, France, 35033
        • Investigational Site Number 250005
      • Rouen Cedex, France, 76038
        • Investigational Site Number 250003
      • Villejuif Cedex, France, 94805
        • Investigational Site Number 250002
  • Norway
      • Oslo, Norway, 0440
        • Investigational Site Number 578001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SAR3419 + Rituximab
Combined therapy will be administered intravenously for 8 doses in the absence of unacceptable toxicity, disease progression or withdrawal of consent.
Drug: SAR3419
Pharmaceutical form:solution for infusion Route of administration: Intravenous
Drug: rituximab
Pharmaceutical form:solution for infusion Route of administration: intravenous

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants achieving an Objective Response Rate
Time Frame: 18 weeks
18 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with Adverse Events
Time Frame: Up to 6 months
Up to 6 months
Response Duration -Time
Time Frame: Up to 24 months after the first infusion of the last patient
Up to 24 months after the first infusion of the last patient
Progression Free Survival -Time
Time Frame: Up to 24 months after the first infusion of the last patient
Up to 24 months after the first infusion of the last patient
Overall survival -Time
Time Frame: Up to 24 months after the first infusion of the last patient
Up to 24 months after the first infusion of the last patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

November 9, 2011

First Submitted That Met QC Criteria

November 10, 2011

First Posted (Estimate)

November 11, 2011

Study Record Updates

Last Update Posted (Estimate)

November 13, 2014

Last Update Submitted That Met QC Criteria

November 12, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCD12333
  • 2011-002865-39
  • U1111-1120-0315 (Other Identifier: UTN)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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