Status:
COMPLETED
SAR3419 Administered Weekly in Patients With Relapsed/Refractory CD19-positive B-cell Non-Hodgkin's Lymphoma
Lead Sponsor:
Sanofi
Conditions:
Lymphoma
Non-Hodgkin
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT00796731
Start Date
October 1 2008
End Date
June 1 2012
Last Update
July 17 2012
Active Locations (6)
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1
Sanofi-Aventis Investigational Site Number 250004
Créteil, France, 94010
2
Sanofi-Aventis Investigational Site Number 250006
Lille, France, 59037
3
Sanofi-Aventis Investigational Site Number 250001
Pierre-Bénite, France, 69495
4
Sanofi-Aventis Investigational Site Number 250005
Rennes, France, 35033