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

Diffuse Large B-Cell Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01470456
• Other study ID #: TCD12333
• Secondary ID: 2011-002865-39U1
• Status: Completed
• Phase: Phase 2
• First received: November 9, 2011
• Last updated: November 12, 2014
• Start date: November 2011
• Est. completion date: September 2014

Study information

• Verified date: November 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

Primary Objective:

Participants Achieving an Objective Response Rate (Cheson 2007)

Secondary Objectives:

• Progression Free Survival

• Overall Survival

• Response Duration

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2014
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diffuse Large B-Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

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

Locations

Country	Name	City	State
Austria	Investigational Site Number 040002	Graz
France	Investigational Site Number 250004	Creteil Cedex
France	Investigational Site Number 250009	Dijon
France	Investigational Site Number 250006	Lille Cedex
France	Investigational Site Number 250011	Marseille Cedex 9
France	Investigational Site Number 250010	Montpellier
France	Investigational Site Number 250008	Nantes Cedex 01
France	Investigational Site Number 250007	Paris Cedex 10
France	Investigational Site Number 250001	Pierre Benite Cedex
France	Investigational Site Number 250005	Rennes
France	Investigational Site Number 250003	Rouen Cedex
France	Investigational Site Number 250002	Villejuif Cedex
Norway	Investigational Site Number 578001	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Austria,  France,  Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants achieving an Objective Response Rate		18 weeks	No
Secondary	Number of participants with Adverse Events		Up to 6 months	Yes
Secondary	Response Duration -Time		Up to 24 months after the first infusion of the last patient	No
Secondary	Progression Free Survival -Time		Up to 24 months after the first infusion of the last patient	No
Secondary	Overall survival -Time		Up to 24 months after the first infusion of the last patient	No