NCT01470456

Brief Summary

Primary Objective: Participants Achieving an Objective Response Rate (Cheson 2007) Secondary Objectives:

  • Progression Free Survival
  • Overall Survival
  • Response Duration

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2011

Typical duration for phase_2

Geographic Reach
3 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 11, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

November 13, 2014

Status Verified

November 1, 2014

Enrollment Period

1.7 years

First QC Date

November 9, 2011

Last Update Submit

November 12, 2014

Conditions

Diffuse Large B-Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Number of participants achieving an Objective Response Rate

    18 weeks

Secondary Outcomes (4)

  • Number of participants with Adverse Events

    Up to 6 months

  • Response Duration -Time

    Up to 24 months after the first infusion of the last patient

  • Progression Free Survival -Time

    Up to 24 months after the first infusion of the last patient

  • Overall survival -Time

    Up to 24 months after the first infusion of the last patient

Study Arms (1)

SAR3419 + Rituximab

EXPERIMENTAL

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

Drug: SAR3419Drug: rituximab

Interventions

SAR3419DRUG

Pharmaceutical form:solution for infusion Route of administration: Intravenous

SAR3419 + Rituximab
rituximabDRUG

Pharmaceutical form:solution for infusion Route of administration: intravenous

SAR3419 + Rituximab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Investigational Site Number 040002

Graz, 8036, Austria

Location

Investigational Site Number 250004

Créteil, 94010, France

Location

Investigational Site Number 250009

Dijon, 21000, France

Location

Investigational Site Number 250006

Lille, 59037, France

Location

Investigational Site Number 250011

Marseille, 13273, France

Location

Investigational Site Number 250010

Montpellier, 34295, France

Location

Investigational Site Number 250008

Nantes, 44093, France

Location

Investigational Site Number 250007

Paris, 75475, France

Location

Investigational Site Number 250001

Pierre-Bénite, 69495, France

Location

Investigational Site Number 250005

Rennes, 35033, France

Location

Investigational Site Number 250003

Rouen, 76038, France

Location

Investigational Site Number 250002

Villejuif, 94805, France

Location

Investigational Site Number 578001

Oslo, 0440, Norway

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

coltuximab ravtansineRituximab

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2011

First Posted

November 11, 2011

Study Start

November 1, 2011

Primary Completion

July 1, 2013

Study Completion

September 1, 2014

Last Updated

November 13, 2014

Record last verified: 2014-11

Locations

NO(1)AU(1)FR(11)