Clinical trial NCT00796731: SAR3419 Administered Weekly in Patients With Relapsed/Refractory CD19-positive B-cell Non-Hodgkin's Lymphoma
Official title: A Dose-escalation, Safety and Pharmacokinetic Study of SAR3419 Administered as a Single Agent by Intravenous Infusion Once Weekly in Patients With Relapsed/Refractory CD19-positive B-cell Non-Hodgkin's Lymphoma (NHL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lymphoma
Non-Hodgkin
Keywords: B-cell lymphoma
NHL
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-11-24
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Incidence of DLT(s) at each dose level
timeFrame: during the initial 3-week period of treatment
Secondary outcomes:
measure: Cumulative DLT(s)
timeFrame: over the entire period of treatment
measure: Incidence of Adverse Events and laboratory abnormalities
timeFrame: study period
measure: Tumor response (complete response, partial response) and duration of the response
timeFrame: study period
measure: Pharmacokinetics parameters
timeFrame: Study period
Other outcomes:
Locations:
city: Creteil Cedex
country: France
facility: Sanofi-Aventis Investigational Site Number 250004
city: Lille Cedex
country: France
facility: Sanofi-Aventis Investigational Site Number 250006
city: Pierre Benite Cedex
country: France
facility: Sanofi-Aventis Investigational Site Number 250001
city: Rennes
country: France
facility: Sanofi-Aventis Investigational Site Number 250005
city: Rouen Cedex
country: France
facility: Sanofi-Aventis Investigational Site Number 250003
city: Villejuif Cedex
country: France
facility: Sanofi-Aventis Investigational Site Number 250002
Study officials:
affiliation: Centre Hospitalier Lyon Sud, France
name: Bertrand COIFFIER, Professor of Hematology
role: PRINCIPAL_INVESTIGATOR
References: