Skip to main content
OpenTrials
Completed

NCT Number: NCT01470456

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

Primary Objective:

Participants Achieving an Objective Response Rate (Cheson 2007)

Secondary Objectives:

* Progression Free Survival * Overall Survival * Response Duration

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diffuse Large B-cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigational Site Number 040002, Graz, Austria

Loading trial locations.

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SAR3419

Drug

Pharmaceutical form:solution for infusion Route of administration: Intravenous

Rituximab

Drug

Pharmaceutical form:solution for infusion Route of administration: intravenous

Primary outcomes

  1. Number of participants achieving an Objective Response Rate

    Time frame: 18 weeks

Secondary outcomes

  1. Number of participants with Adverse Events

    Time frame: Up to 6 months

  2. Response Duration -Time

    Time frame: Up to 24 months after the first infusion of the last patient

  3. Progression Free Survival -Time

    Time frame: Up to 24 months after the first infusion of the last patient

  4. Overall survival -Time

    Time frame: Up to 24 months after the first infusion of the last patient

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Nov 11, 2011
Registry last updated
Nov 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.