| SAR3419 Administered Weekly in Patients With Relapsed/Refractory CD19-Positive B-Cell Non-Hodgkin's Lymphoma
Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
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| Phase I | Treatment | Active | 18 and over | TED6829
EudraCT 2007-004868-41, NCT00796731 |
Trial Description
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.
Trial Contact Information
Trial Lead Organizations/Sponsors Sanofi-Aventis - US - Bridgewater | Bertrand Coiffier |  | Principal Investigator |
Trial Sites
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| France |
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Paris |
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| | | | | | | | Sanofi-Aventis France |
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Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00796731
Information obtained from ClinicalTrials.gov on March 18, 2009 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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