EUCTR2011-003657-26-GB
Active, not recruiting
Phase 1
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 - STARLYTE
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Diffuse large B-cell lymphoma
- Sponsor
- sanofi aventis recherche et développement
- Enrollment
- 61
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histological diagnosis of DLBCL (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 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 study treatment infusion. Cryo\-preserved tissue cannot be used. If archival material is not available, at least a Fine Needle Aspiration (FNA) must be obtained. Archival diagnosis biopsy may be used retrospectively as a complementary material for biomarkers analysis (Refer to section 9\.5\.1\). If necessary, a specific informed consent will be signed.
- •Signed written informed consent
Exclusion Criteria
- •Primary refractory patients
- •Patients with primary mediastinal DLBCL
Outcomes
Primary Outcomes
Not specified
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