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

November 14, 2011
November 26, 2013
January 2012
February 2015   (final data collection date for primary outcome measure)
Number of participants achieving an Objective Response Rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01472887 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
SAR3419 as Single Agent in Relapsed-Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Patients
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

Primary Objective:

Participants achieving an Objective Response Rate

Secondary Objective:

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

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Diffuse Large B-cell Lymphoma
Drug: SAR3419

Pharmaceutical form:concentrate for solution for infusion

Route of administration: intravenous

Experimental: SAR3419
All patients will receive SAR3419 until evidence of disease progression, unacceptable toxicity, or other reasons for therapy discontinuation
Intervention: Drug: SAR3419
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
55
February 2015
February 2015   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Czech Republic,   Israel,   Italy,   Poland,   Spain,   Turkey,   United Kingdom,   United States
 
NCT01472887
ARD10248, 2011-003657-26, U1111-1115-3349
No
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP