Multi-dose-escalation Safety and Pharmacokinetic Study of SAR3419 as Single Agent in Relapsed/Refractory B-cell Non Hodgkin's Lymphoma
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)
1 other identifier
interventional
39
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 lymphoma
Started Oct 2007
Typical duration for phase_1 lymphoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 24, 2007
CompletedFirst Posted
Study publicly available on registry
October 25, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedFebruary 14, 2012
February 1, 2012
4.3 years
October 24, 2007
February 13, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of Dose Limiting Toxicity(ies) at each tested dose level
Study period
Secondary Outcomes (2)
Tumor response (complete response, partial response, stable disease) according to Cheson criteria and duration of response
Study period
Incidence of Adverse Events
Study period
Interventions
Intravenous infusion
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (1)
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Sciences & Operations
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2007
First Posted
October 25, 2007
Study Start
October 1, 2007
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
February 14, 2012
Record last verified: 2012-02