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

NCT ID: NCT01470456

Last Updated: 2014-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2014-09-30

Brief Summary

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Primary Objective:

Participants Achieving an Objective Response Rate (Cheson 2007)

Secondary Objectives:

* Progression Free Survival
* Overall Survival
* Response Duration

Detailed Description

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* 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.

Conditions

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Diffuse Large B-Cell Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SAR3419 + Rituximab

Combined therapy will be administered intravenously for 8 doses in the absence of unacceptable toxicity, disease progression or withdrawal of consent.

Group Type EXPERIMENTAL

SAR3419

Intervention Type DRUG

Pharmaceutical form:solution for infusion Route of administration: Intravenous

rituximab

Intervention Type DRUG

Pharmaceutical form:solution for infusion Route of administration: intravenous

Interventions

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SAR3419

Pharmaceutical form:solution for infusion Route of administration: Intravenous

Intervention Type DRUG

rituximab

Pharmaceutical form:solution for infusion Route of administration: intravenous

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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Investigational Site Number 040002

Graz, , Austria

Site Status

Investigational Site Number 250004

Créteil, , France

Site Status

Investigational Site Number 250009

Dijon, , France

Site Status

Investigational Site Number 250006

Lille, , France

Site Status

Investigational Site Number 250011

Marseille, , France

Site Status

Investigational Site Number 250010

Montpellier, , France

Site Status

Investigational Site Number 250008

Nantes, , France

Site Status

Investigational Site Number 250007

Paris, , France

Site Status

Investigational Site Number 250001

Pierre-Bénite, , France

Site Status

Investigational Site Number 250005

Rennes, , France

Site Status

Investigational Site Number 250003

Rouen, , France

Site Status

Investigational Site Number 250002

Villejuif, , France

Site Status

Investigational Site Number 578001

Oslo, , Norway

Site Status

Countries

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Austria France Norway

Other Identifiers

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2011-002865-39

Identifier Type: -

Identifier Source: secondary_id

U1111-1120-0315

Identifier Type: OTHER

Identifier Source: secondary_id

TCD12333

Identifier Type: -

Identifier Source: org_study_id