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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01470456

Enrollment

Registered

2011-11-11

Start date

2011-11-30

Completion date

2014-09-30

Last updated

2014-11-13

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

Brief summary

Primary Objective: Participants Achieving an Objective Response Rate (Cheson 2007) Secondary Objectives: * Progression Free Survival * Overall Survival * Response Duration

Detailed description

* The screening period = up to 4 weeks prior to the first administration of combined therapy * The treatment period = 3 months of combined therapy. A safety follow-up of 42 to 49 days after the last dose of treatment is planned for all patients. * The follow-up period: Patients who are not progressing at the end of study treatment will be followed until progression or initiation of another anti-lymphoma therapy. All patients will be followed for two years to evaluate survival.

Interventions

DRUGSAR3419

Pharmaceutical form:solution for infusion Route of administration: Intravenous

DRUGrituximab

Pharmaceutical form:solution for infusion Route of administration: intravenous

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Number of participants achieving an Objective Response Rate	18 weeks

Secondary

Measure	Time frame
Number of participants with Adverse Events	Up to 6 months
Response Duration -Time	Up to 24 months after the first infusion of the last patient
Progression Free Survival -Time	Up to 24 months after the first infusion of the last patient
Overall survival -Time	Up to 24 months after the first infusion of the last patient

Countries

Austria, France, Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026