NCT00549185CompletedPhase 1
An Open-label Multi-dose-escalation, Safety and Pharmacokinetic Study of SAR3419 Administered as a Single Agent by Intravenous Infusion Every 3 Weeks in Patients With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma (NHL)
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Sanofi
- Enrollment
- 39
- Locations
- 2
- Primary Endpoint
- Incidence of Dose Limiting Toxicity(ies) at each tested dose level
Study Overview
Brief Summary
The primary objective is to determine the maximum tolerated dose of SAR3419 and to characterize the dose limiting toxicity(ies). Secondary objectives are to determine the anti-lymphoma activity, the global safety and the PK profile.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histologically confirmed CD19-positive non-Hodgkin's B-cell lymphoma, relapsed or refractory after standard treatments, with no curative option with conventional therapy
- •ECOG performance status 0 to 2
Exclusion Criteria
- •Burkitt's lymphoma, Lymphoblastic lymphoma, Chronic lymphocytic leukemia (Small lymphocytic lymphoma may be included)
- •Chemotherapy or radiation therapy or other investigational agents within 4 weeks prior to entering the study
- •Previous radioimmunotherapy within 12 weeks
- •Known intolerance to infused protein products or maytansinoids
- •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 with compliance with the study
- •Pregnant or breast-feeding women
- •Patient 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.
Outcomes
Primary Outcomes
Incidence of Dose Limiting Toxicity(ies) at each tested dose level
Time Frame: Study period
Secondary Outcomes
- Tumor response (complete response, partial response, stable disease) according to Cheson criteria and duration of response(Study period)
- Incidence of Adverse Events(Study period)
Investigators
Study Sites (2)
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