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SAR3419 as Single Agent in Relapsed-Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Patients (STARLYTE)

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. Identifier: NCT01472887
Recruitment Status : Completed
First Posted : November 17, 2011
Last Update Posted : January 25, 2018
Information provided by (Responsible Party):

Brief Summary:

Primary Objective:

Participants achieving an Objective Response Rate

Secondary Objective:

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

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2012
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
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

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

Secondary Outcome Measures :
  1. Number of participants with Adverse Events [ Time Frame: Up to 1 year ]
  2. Response duration - Time [ Time Frame: Up to 18 months after the first infusion of the last patient ]
  3. Progression Free Survival - Time [ Time Frame: Up to 18 months after the first infusion of the last patient ]
  4. Overall Survival - Time [ Time Frame: Up to 18 months after the first infusion of the last patient ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

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.

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 identifier (NCT number): NCT01472887

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United States, Colorado
Investigational Site Number 840001
Denver, Colorado, United States, 80262
United States, Georgia
Investigational Site Number 840003
Augusta, Georgia, United States, 30912
United States, Idaho
Investigational Site Number 840005
Boise, Idaho, United States, 83712
Investigational Site Number 056002
Gent, Belgium, 9000
Investigational Site Number 056001
Leuven, Belgium, 3000
Investigational Site Number 203002
Brno, Czechia, 62500
Investigational Site Number 203003
Praha 10, Czechia, 10034
Investigational Site Number 203001
Praha 2, Czechia, 12808
Investigational Site Number 376003
Jerusalem, Israel, 91120
Investigational Site Number 376002
Tel Hashomer, Israel, 52621
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
Investigational Site Number 616003
Brzozow, Poland, 36-200
Investigational Site Number 616002
Kielce, Poland, 25-734
Investigational Site Number 616001
Warszawa, Poland, 04-141
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, 46010
Investigational Site Number 792003
Izmir, Turkey, 35040
Investigational Site Number 792001
Izmir, Turkey, 35340
United Kingdom
Investigational Site Number 826001
Leicester, United Kingdom
Investigational Site Number 826002
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
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Study Director: Clinical Sciences & Operations Sanofi

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Sanofi Identifier: NCT01472887     History of Changes
Other Study ID Numbers: ARD10248
U1111-1115-3349 ( Other Identifier: UTN )
First Posted: November 17, 2011    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action