SAR3419 as Single Agent in Relapsed-Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Patients (STARLYTE)
This study is currently recruiting participants.
Verified April 2013 by Sanofi
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01472887
First received: November 14, 2011
Last updated: April 18, 2013
Last verified: April 2013
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01472887
Show 31 Study Locations
Contacts
| Contact: For site information, send an email with site number to | Contact-Us@sanofi.com |
Show 31 Study LocationsSponsors 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: | April 18, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on May 21, 2013