Trial record 1 of 1 for:    ARD10248
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SAR3419 as Single Agent in Relapsed-Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Patients (STARLYTE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01472887
First received: November 14, 2011
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

Primary Objective:

Participants achieving an Objective Response Rate

Secondary Objective:

  • Progression Free Survival
  • Overall Survival
  • Response Duration
  • Safety

Condition Intervention Phase
Diffuse Large B-cell Lymphoma
Drug: SAR3419
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Non-Randomized Phase 2 Study Evaluating SAR3419, an Anti-CD19 Antibody - Maytansine Conjugate, Administered as Single Agent by Intravenous Infusion to Patients With Relapsed or Refractory CD19+ Diffuse Large B-Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Number of participants achieving an Objective Response Rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of participants with Adverse Events [ Time Frame: Up to 1 year ] [ Designated as safety issue: Yes ]
  • Response duration - Time [ Time Frame: Up to 18 months after the first infusion of the last patient ] [ Designated as safety issue: No ]
  • Progression Free Survival - Time [ Time Frame: Up to 18 months after the first infusion of the last patient ] [ Designated as safety issue: No ]
  • Overall Survival - Time [ Time Frame: Up to 18 months after the first infusion of the last patient ] [ Designated as safety issue: No ]

Estimated Enrollment: 55
Study Start Date: January 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SAR3419
All patients will receive SAR3419 until evidence of disease progression, unacceptable toxicity, or other reasons for therapy discontinuation
Drug: SAR3419

Pharmaceutical form:concentrate for solution for infusion

Route of administration: intravenous


Detailed Description:

The screening period = up to 4 weeks prior to SAR3419 administration

The treatment period = from the day of first administration of SAR3419 until the End-Of-Treatment visit. All patients will receive SAR3419 until evidence of disease progression, unacceptable toxicity or other reasons for therapy discontinuation - After therapy discontinuation all patients will enter a safety follow-up period of 42 days starting from the day of administration of the last dose of SAR3419 and ending with the End Of Treatment visit.

All patients, regardless whether they have progressed or not, will be followed until death or end of study to evaluate survival for at least 18 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Histological diagnosis of Diffuse Large B Cell Lymphoma (de novo or transformed) expressing CD19 by immunohistochemistry or flow cytometry analysis (>30% positivity), based on recent (less than 6 months) or new biopsy.
  • At least 1 prior specific therapeutic regimen, one of which should have included rituximab (patients previously eligible for transplantation: the salvage treatment followed by intensification and Autologous Stem Cell Transplant (ASCT) will be considered one regimen).
  • Relapsed disease after standard 1st line therapy for aggressive lymphoma - not eligible for high dose chemotherapy with stem cell support. Relapsed or refractory disease after two lines of therapy one of which could have included Autologous Stem Cell Transplant (ASCT). Relapsed disease is defined as progression after a disease free interval of at least 6 months after completion of last therapy. Refractory is defined as progression of disease during prior therapy or within 6 months from its completion.
  • Available paraffin-embedded tissue should have been collected no longer than 6 months prior to first administration of SAR3419. Cryo-preserved tissue cannot be used. If archival material is not available, a Fine Needle Aspiration (FNA) must be obtained.

Exclusion criteria:

  • Primary refractory patients
  • Patients with primary mediastinal DLBCL

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01472887

  Hide Study Locations
Locations
United States, Colorado
Investigational Site Number 840001
Denver, Colorado, United States, 80262
United States, Georgia
Investigational Site Number 840002
Atlanta, Georgia, United States, 30322
Investigational Site Number 840003
Augusta, Georgia, United States, 30912
United States, Idaho
Investigational Site Number 840005
Boise, Idaho, United States, 83712
Belgium
Investigational Site Number 056002
Gent, Belgium, 9000
Investigational Site Number 056001
Leuven, Belgium, 3000
Czech Republic
Investigational Site Number 203002
Brno, Czech Republic, 62500
Investigational Site Number 203003
Praha 10, Czech Republic, 10034
Investigational Site Number 203001
Praha 2, Czech Republic, 12808
Israel
Investigational Site Number 376003
Jerusalem, Israel, 91120
Investigational Site Number 376002
Tel Hashomer, Israel, 52621
Italy
Investigational Site Number 380002
Bergamo, Italy, 24127
Investigational Site Number 380004
Bologna, Italy, 40138
Investigational Site Number 380008
Mestre, Italy, 30174
Investigational Site Number 380001
Milano, Italy, 20133
Investigational Site Number 380007
Modena, Italy, 41100
Investigational Site Number 380003
Palermo, Italy, 90145
Investigational Site Number 380006
Pavia, Italy, 27100
Poland
Investigational Site Number 616003
Brzozow, Poland, 36-200
Investigational Site Number 616002
Poland, Poland, 25-734
Investigational Site Number 616001
Warszawa, Poland, 04-141
Spain
Investigational Site Number 724002
Barcelona, Spain, 08003
Investigational Site Number 724004
Barcelona, Spain, 08035
Investigational Site Number 724001
Madrid, Spain, 28046
Investigational Site Number 724003
Valencia, Spain
Turkey
Investigational Site Number 792001
Izmir, Turkey, 35340
Investigational Site Number 792003
Izmir, Turkey, 35040
United Kingdom
Investigational Site Number 826001
Leicester, United Kingdom
Investigational Site Number 826002
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01472887     History of Changes
Other Study ID Numbers: ARD10248, 2011-003657-26, U1111-1115-3349
Study First Received: November 14, 2011
Last Updated: November 26, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on September 16, 2014