Clinical trial NCT01470456: Combination of SAR3419 and Rituximab in Relapsed/Refractory Diffuse Large B-Cell Lymphoma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diffuse Large B-Cell Lymphoma
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2011-11-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary Objective:

Participants Achieving an Objective Response Rate (Cheson 2007)

Secondary Objectives:

* Progression Free Survival
* Overall Survival
* Response Duration

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 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.

Primary outcomes:
measure: Number of participants achieving an Objective Response Rate
timeFrame: 18 weeks
Secondary outcomes:
measure: Number of participants with Adverse Events
timeFrame: Up to 6 months
measure: Response Duration -Time
timeFrame: Up to 24 months after the first infusion of the last patient
measure: Progression Free Survival -Time
timeFrame: Up to 24 months after the first infusion of the last patient
measure: Overall survival -Time
timeFrame: Up to 24 months after the first infusion of the last patient
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Investigational Site Number 040002
city: Creteil Cedex
country: France
facility: Investigational Site Number 250004
city: Dijon
country: France
facility: Investigational Site Number 250009
city: Lille Cedex
country: France
facility: Investigational Site Number 250006
city: Marseille Cedex 9
country: France
facility: Investigational Site Number 250011
city: Montpellier
country: France
facility: Investigational Site Number 250010
city: Nantes Cedex 01
country: France
facility: Investigational Site Number 250008
city: Paris Cedex 10
country: France
facility: Investigational Site Number 250007
city: Pierre Benite Cedex
country: France
facility: Investigational Site Number 250001
city: Rennes
country: France
facility: Investigational Site Number 250005
city: Rouen Cedex
country: France
facility: Investigational Site Number 250003
city: Villejuif Cedex
country: France
facility: Investigational Site Number 250002
city: Oslo
country: Norway
facility: Investigational Site Number 578001
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: