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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-003657-26-CZ

Enrollment

Registered

2011-09-16

Start date

2012-01-16

Completion date

Unknown

Last updated

2017-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diffuse large B-cell lymphoma MedDRA version: 14.0 Level: PT Classification code 10012818 Term: Diffuse large B-cell lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Product Code: SAR3419 Pharmaceutical Form: Solution for infusion Current Sponsor code: SAR3419 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Histological diagnosis of Diffuse Large B Cell Lymphoma (de novo or transformed) based on recent (less than 3 months) or new biopsy, expressing CD19 by immunohistochemistry or flow cytometry analysis (at least or more than 30% positivity). • At least 1 and not more than 2 prior specific therapeutic regimens, one of which should have included rituximab • 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 3 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. • Signed written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 22 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 33

Exclusion criteria

Exclusion criteria: • Primary refractory patients • Patients with primary mediastinal DLBCL

Design outcomes

Primary

Measure	Time frame
Main Objective: Objective Response Rate;Secondary Objective: Safety, Response Duration, Progression Free Survival, Overall Survival;Primary end point(s): Objective Response Rate;Timepoint(s) of evaluation of this end point: 18 months	—

Secondary

Measure	Time frame
Secondary end point(s): Safety Response Duration, Progression Free Survival, Overall Survival;Timepoint(s) of evaluation of this end point: Safety : treatment period Response Duration, Progression Free Survival, Overall Survival : up to 18 months after the first infusion of the last patient	—

Countries

Australia, Belgium, Czech Republic, Israel, Italy, Spain, United Kingdom, United States

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026