Multi-dose-escalation Safety and Pharmacokinetic Study of SAR3419 as Single Agent in Relapsed/Refractory B-cell Non Hodgkin's Lymphoma

An Open-label Multi-dose-escalation, Safety and Pharmacokinetic Study of SAR3419 Administered as a Single Agent by Intravenous Infusion Every 3 Weeks in Patients With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma (NHL)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00549185

Enrollment

Registered

2007-10-25

Start date

2007-10-31

Completion date

2012-01-31

Last updated

2012-02-14

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

Conditions

Lymphoma, Non-Hodgkin

Brief summary

The primary objective is to determine the maximum tolerated dose of SAR3419 and to characterize the dose limiting toxicity(ies). Secondary objectives are to determine the anti-lymphoma activity, the global safety and the PK profile.

Interventions

DRUGSAR3419

Intravenous infusion

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Histologically confirmed CD19-positive non-Hodgkin's B-cell lymphoma, relapsed or refractory after standard treatments, with no curative option with conventional therapy * ECOG performance status 0 to 2

Exclusion criteria

* Burkitt's lymphoma, Lymphoblastic lymphoma, Chronic lymphocytic leukemia (Small lymphocytic lymphoma may be included) * Chemotherapy or radiation therapy or other investigational agents within 4 weeks prior to entering the study * Previous radioimmunotherapy within 12 weeks * Known intolerance to infused protein products or maytansinoids * Poor kidney, liver and bone marrow functions * Any serious active disease or co-morbid condition, which in the opinion of the principle investigator, will interfere with the safety or with compliance with the study * Pregnant or breast-feeding women * Patient with reproductive potential without effective birth control methods 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
Incidence of Dose Limiting Toxicity(ies) at each tested dose level	Study period

Secondary

Measure	Time frame
Tumor response (complete response, partial response, stable disease) according to Cheson criteria and duration of response	Study period
Incidence of Adverse Events	Study period

Countries

United States

Outcome results

None listed

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