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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01470456
Recruitment Status : Completed
First Posted : November 11, 2011
Last Update Posted : November 13, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief Summary:

Primary Objective:

Participants Achieving an Objective Response Rate (Cheson 2007)

Secondary Objectives:

  • Progression Free Survival
  • Overall Survival
  • Response Duration

Condition or disease Intervention/treatment Phase
Diffuse Large B-Cell Lymphoma Drug: SAR3419 Drug: rituximab Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2011
Actual Primary Completion Date : July 2013
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Arm Intervention/treatment
Experimental: SAR3419 + Rituximab
Combined therapy will be administered intravenously for 8 doses in the absence of unacceptable toxicity, disease progression or withdrawal of consent.
Drug: SAR3419
Pharmaceutical form:solution for infusion Route of administration: Intravenous

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




Primary Outcome Measures :
  1. Number of participants achieving an Objective Response Rate [ Time Frame: 18 weeks ]

Secondary Outcome Measures :
  1. Number of participants with Adverse Events [ Time Frame: Up to 6 months ]
  2. Response Duration -Time [ Time Frame: Up to 24 months after the first infusion of the last patient ]
  3. Progression Free Survival -Time [ Time Frame: Up to 24 months after the first infusion of the last patient ]
  4. Overall survival -Time [ Time Frame: Up to 24 months after the first infusion of the last patient ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01470456


Locations
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Austria
Investigational Site Number 040002
Graz, Austria, 8036
France
Investigational Site Number 250004
Creteil Cedex, France, 94010
Investigational Site Number 250009
Dijon, France, 21000
Investigational Site Number 250006
Lille Cedex, France, 59037
Investigational Site Number 250011
Marseille Cedex 9, France, 13273
Investigational Site Number 250010
Montpellier, France, 34295
Investigational Site Number 250008
Nantes Cedex 01, France, 44093
Investigational Site Number 250007
Paris Cedex 10, France, 75475
Investigational Site Number 250001
Pierre Benite Cedex, France, 69495
Investigational Site Number 250005
Rennes, France, 35033
Investigational Site Number 250003
Rouen Cedex, France, 76038
Investigational Site Number 250002
Villejuif Cedex, France, 94805
Norway
Investigational Site Number 578001
Oslo, Norway, 0440
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01470456    
Other Study ID Numbers: TCD12333
2011-002865-39
U1111-1120-0315 ( Other Identifier: UTN )
First Posted: November 11, 2011    Key Record Dates
Last Update Posted: November 13, 2014
Last Verified: November 2014
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents