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

This study is currently recruiting participants.
Verified June 2012 by Sanofi-Aventis

First Received on November 9, 2011.  
Last Updated on June 12, 2012  
History of Changes
This Clinical Trial Sponsored By: Sanofi-Aventis
Information provided by (Responsible Party): Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT01470456
 

Purpose for Clinical Trial

Primary Objective:

Participants Achieving an Objective Response Rate (Cheson 2007)

Secondary Objectives:

  • Progression Free Survival
  • Overall Survival
  • Response Duration

Condition Study Intervention Clinical Trial Phase
Diffuse Large B-Cell Lymphoma Drug: SAR3419
Drug: rituximab
Phase 2

Study Type: Study Interventional
Study Design: Endpoint Classification: Efficacy Study
Study Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics:
Lymphoma
Drug Information available for:
Rituximab

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures For Clinical Trial:

  • Number of participants achieving an Objective Response Rate [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures For Clinical Trial:

  • Number of participants with Adverse Events [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]
  • Response Duration -Time [ Time Frame: Up to 24 months after the first infusion of the last patient ] [ Designated as safety issue: No ]
  • Progression Free Survival -Time [ Time Frame: Up to 24 months after the first infusion of the last patient ] [ Designated as safety issue: No ]
  • Overall survival -Time [ Time Frame: Up to 24 months after the first infusion of the last patient ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: November 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)

Arms

Assigned Study Interventions

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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01470456

Contacts
Contact: For site information, send an email with site number to Contact-Us@sanofi-aventis.com

Locations
France
Investigational Site Number 250004 Recruiting
Creteil Cedex, France, 94010
Investigational Site Number 250006 Recruiting
Lille Cedex, France, 59037
Investigational Site Number 250008 Recruiting
Nantes Cedex 01, France, 44093
Investigational Site Number 250007 Recruiting
Paris Cedex 10, France, 75475
Investigational Site Number 250001 Recruiting
Pierre Benite Cedex, France, 69495
Investigational Site Number 250005 Recruiting
Rennes, France, 35033
Investigational Site Number 250003 Recruiting
Rouen Cedex, France, 76038
Investigational Site Number 250002 Recruiting
Villejuif Cedex, France, 94805
Sponsors and Collaborators
Sanofi-Aventis
Investigators

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