Lymphoma, Non-Hodgkin
Conditions
Keywords
B-cell lymphoma, NHL
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.
Interventions
DRUGSAR3419
administered by intravenous infusion
Sponsors
Sanofi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of DLT(s) at each dose level | during the initial 3-week period of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Cumulative DLT(s) | over the entire period of treatment |
| Incidence of Adverse Events and laboratory abnormalities | study period |
| Tumor response (complete response, partial response) and duration of the response | study period |
| Pharmacokinetics parameters | Study period |
Countries
France
Outcome results
None listed