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

Primary Purpose

Diffuse Large B-Cell Lymphoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SAR3419
rituximab
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diffuse Large B-Cell Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigational Site Number 040002
  • Investigational Site Number 250004
  • Investigational Site Number 250009
  • Investigational Site Number 250006
  • Investigational Site Number 250011
  • Investigational Site Number 250010
  • Investigational Site Number 250008
  • Investigational Site Number 250007
  • Investigational Site Number 250001
  • Investigational Site Number 250005
  • Investigational Site Number 250003
  • Investigational Site Number 250002
  • Investigational Site Number 578001

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SAR3419 + Rituximab

Arm Description

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

Outcomes

Primary Outcome Measures

Number of participants achieving an Objective Response Rate

Secondary Outcome Measures

Number of participants with Adverse Events
Response Duration -Time
Progression Free Survival -Time
Overall survival -Time

Full Information

First Posted
November 9, 2011
Last Updated
November 12, 2014
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT01470456
Brief Title
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

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B-Cell Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SAR3419 + Rituximab
Arm Type
Experimental
Arm Description
Combined therapy will be administered intravenously for 8 doses in the absence of unacceptable toxicity, disease progression or withdrawal of consent.
Intervention Type
Drug
Intervention Name(s)
SAR3419
Intervention Description
Pharmaceutical form:solution for infusion Route of administration: Intravenous
Intervention Type
Drug
Intervention Name(s)
rituximab
Intervention Description
Pharmaceutical form:solution for infusion Route of administration: intravenous
Primary Outcome Measure Information:
Title
Number of participants achieving an Objective Response Rate
Time Frame
18 weeks
Secondary Outcome Measure Information:
Title
Number of participants with Adverse Events
Time Frame
Up to 6 months
Title
Response Duration -Time
Time Frame
Up to 24 months after the first infusion of the last patient
Title
Progression Free Survival -Time
Time Frame
Up to 24 months after the first infusion of the last patient
Title
Overall survival -Time
Time Frame
Up to 24 months after the first infusion of the last patient

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 040002
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Investigational Site Number 250004
City
Creteil Cedex
ZIP/Postal Code
94010
Country
France
Facility Name
Investigational Site Number 250009
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Investigational Site Number 250006
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Investigational Site Number 250011
City
Marseille Cedex 9
ZIP/Postal Code
13273
Country
France
Facility Name
Investigational Site Number 250010
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Investigational Site Number 250008
City
Nantes Cedex 01
ZIP/Postal Code
44093
Country
France
Facility Name
Investigational Site Number 250007
City
Paris Cedex 10
ZIP/Postal Code
75475
Country
France
Facility Name
Investigational Site Number 250001
City
Pierre Benite Cedex
ZIP/Postal Code
69495
Country
France
Facility Name
Investigational Site Number 250005
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Investigational Site Number 250003
City
Rouen Cedex
ZIP/Postal Code
76038
Country
France
Facility Name
Investigational Site Number 250002
City
Villejuif Cedex
ZIP/Postal Code
94805
Country
France
Facility Name
Investigational Site Number 578001
City
Oslo
ZIP/Postal Code
0440
Country
Norway

12. IPD Sharing Statement

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

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