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

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

First Received on November 14, 2011.  
Last Updated on July 25, 2012  
History of Changes
This Clinical Trial Sponsored By: Sanofi-Aventis
Information provided by (Responsible Party): Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT01472887
 

Purpose for Clinical Trial

Primary Objective:

Participants achieving an Objective Response Rate

Secondary Objective:

  • Progression Free Survival
  • Overall Survival
  • Response Duration
  • Safety

Condition Study Intervention Clinical Trial Phase
Diffuse Large B-cell Lymphoma Drug: SAR3419 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 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

Resource links provided by NLM:

MedlinePlus related topics:
Lymphoma

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 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures For Clinical Trial:

  • Number of participants with Adverse Events [ Time Frame: Up to 1 year ] [ Designated as safety issue: Yes ]
  • Response duration – Time [ Time Frame: Up to 18 months after the first infusion of the last patient ] [ Designated as safety issue: No ]
  • Progression Free Survival – Time [ Time Frame: Up to 18 months after the first infusion of the last patient ] [ Designated as safety issue: No ]
  • Overall Survival – Time [ Time Frame: Up to 18 months after the first infusion of the last patient ] [ Designated as safety issue: No ]

Estimated Enrollment: 55
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

Arms

Assigned Study Interventions

Experimental: SAR3419

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

Pharmaceutical form:concentrate for solution for infusion

Route of administration: intravenous

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.

  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 (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 and not more than 2 prior specific therapeutic regimens, 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.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01472887

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

Locations
United States, Colorado
Investigational Site Number 840001 Recruiting
Denver, Colorado, United States, 80262
United States, Georgia
Investigational Site Number 840002 Recruiting
Atlanta, Georgia, United States, 30322
Investigational Site Number 840003 Recruiting
Augusta, Georgia, United States, 30912
Belgium
Investigational Site Number 056002 Recruiting
Gent, Belgium, 9000
Investigational Site Number 056001 Recruiting
Leuven, Belgium, 3000
Czech Republic
Investigational Site Number 203002 Recruiting
Brno, Czech Republic, 62500
Investigational Site Number 203003

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