Back to resultsMulti-dose-escalation Safety and Pharmacokinetic Study of SAR3419 as Single Agent in Relapsed/Refractory B-cell Non Hodgkin's Lymphoma
Primary Purpose
Lymphoma, Non-Hodgkin
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SAR3419
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma
Eligibility Criteria
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.
Sites / Locations
- Sanofi-Aventis Administrative Office
Outcomes
Primary Outcome Measures
Incidence of Dose Limiting Toxicity(ies) at each tested dose level
Secondary Outcome Measures
Tumor response (complete response, partial response, stable disease) according to Cheson criteria and duration of response
Incidence of Adverse Events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00549185
Brief Title
Multi-dose-escalation Safety and Pharmacokinetic Study of SAR3419 as Single Agent in Relapsed/Refractory B-cell Non Hodgkin's Lymphoma
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Non-Hodgkin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
SAR3419
Intervention Description
Intravenous infusion
Primary Outcome Measure Information:
Title
Incidence of Dose Limiting Toxicity(ies) at each tested dose level
Time Frame
Study period
Secondary Outcome Measure Information:
Title
Tumor response (complete response, partial response, stable disease) according to Cheson criteria and duration of response
Time Frame
Study period
Title
Incidence of Adverse Events
Time Frame
Study period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Multi-dose-escalation Safety and Pharmacokinetic Study of SAR3419 as Single Agent in Relapsed/Refractory B-cell Non Hodgkin's Lymphoma
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