Clinical trial · Interventional
Combination of SAR3419 and Rituximab in Relapsed/Refractory Diffuse Large B-Cell Lymphoma
An Open Label, Multicenter Phase II Study of Intravenous SAR3419, an Anti-CD19 Antibody-Maytansine Conjugate, in Combination With Rituximab in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphomas
NCT01470456CI-TRIAL-00016049completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Primary Objective: Participants Achieving an Objective Response Rate (Cheson 2007) Secondary Objectives: * Progression Free Survival * Overall Survival * Response Duration
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B-Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| rituximab | Drug | Rituximab | ALIAS |
| SAR3419 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SAR3419 + Rituximab
- description
- Combined therapy will be administered intravenously for 8 doses in the absence of unacceptable toxicity, disease progression or withdrawal of consent.
- interventionNames
- Drug: SAR3419
- Drug: rituximab
Primary outcomes (1)
- measure
- Number of participants achieving an Objective Response Rate
- timeFrame
- 18 weeks
Secondary outcomes (4)
- measure
- Number of participants with Adverse Events
- timeFrame
- Up to 6 months
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * Histological diagnosis of Diffuse Large B-Cell Lymphoma (DLBCL) * Relapsed or refractory after at least one standard treatment including rituximab * CD19 and CD20 positive disease Exclusion criteria: * No bi-dimensionally measurable lesion by CT scan (defined as presence of at least one tumor mass measuring \>1.5 x 1.5 cm) * The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
References
Publications (0)
Data not yet available
No reference posted for this study.