SAR3419 Administered Weekly in Patients With Relapsed/Refractory CD19-positive B-cell Non-Hodgkin's Lymphoma

Sanofi

Status and phase

Completed

Phase 1

Conditions

Non-Hodgkin

Lymphoma

Treatments

Drug: SAR3419

Study type

Interventional

Funder types

Industry

Identifiers

NCT00796731

EudraCT 2007-004868-41

TED6829

Details and patient eligibility

About

The primary objective is to determine the maximum tolerated dose (MTD) of SAR3419 according to the dose limiting toxicities (DLTs) observed when administered as a single agent once weekly.

Secondary objectives are:

to characterize the global safety profile
to evaluate the pharmacokinetic (PK) profile of SAR3419 in the proposed dosing schedule
to assess preliminary evidence of anti-lymphoma activity.

Enrollment

77 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of B-cell non Hodgkin's lymphoma
Relapsed or refractory after standard treatments and with no curative option with conventional therapy (Patients having undergone stem cell transplantation may be included)
CD19 positive disease by flow cytometry or immunohistochemistry

Exclusion criteria

Burkitt's lymphoma, Lymphoblastic lymphoma, Chronic lymphocytic leukemia (Small lymphocytic lymphoma may be included)
Evidence of cerebral or meningeal involvement by lymphoma
Patients without bi-dimensionally measurable disease
ECOG performance status > 2
Life expectancy less than 3 months
Chemotherapy or radiation therapy or other investigational agents within 4 weeks prior to entering the study
Previous radioimmunotherapy within 12 weeks
Known anaphylaxis to infused proteins
HIV, HBV and HCV positivity
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 the compliance with the study
Pregnant or breast-feeding women
Patients with reproductive potential without effective birth control methods