SAR3419 Administered Weekly in Patients With Relapsed/Refractory CD19-positive B-cell Non-Hodgkin's Lymphoma
This study has been completed.
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00796731
First received: November 21, 2008
Last updated: July 16, 2012
Last verified: July 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma Non-Hodgkin |
Drug: SAR3419 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Dose-escalation, Safety and Pharmacokinetic Study of SAR3419 Administered as a Single Agent by Intravenous Infusion Once Weekly in Patients With Relapsed/Refractory CD19-positive B-cell Non-Hodgkin's Lymphoma (NHL) |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Incidence of DLT(s) at each dose level [ Time Frame: during the initial 3-week period of treatment ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Cumulative DLT(s) [ Time Frame: over the entire period of treatment ] [ Designated as safety issue: Yes ]
- Incidence of Adverse Events and laboratory abnormalities [ Time Frame: study period ] [ Designated as safety issue: Yes ]
- Tumor response (complete response, partial response) and duration of the response [ Time Frame: study period ] [ Designated as safety issue: No ]
- Pharmacokinetics parameters [ Time Frame: Study period ] [ Designated as safety issue: No ]
| Enrollment: | 77 |
| Study Start Date: | October 2008 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: SAR3419
administered by intravenous infusion
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00796731
Locations
| France | |
| Sanofi-Aventis Investigational Site Number 250004 | |
| Creteil Cedex, France, 94010 | |
| Sanofi-Aventis Investigational Site Number 250006 | |
| Lille Cedex, France, 59037 | |
| Sanofi-Aventis Investigational Site Number 250001 | |
| Pierre Benite Cedex, France, 69495 | |
| Sanofi-Aventis Investigational Site Number 250005 | |
| Rennes, France, 35033 | |
| Sanofi-Aventis Investigational Site Number 250003 | |
| Rouen Cedex, France, 76038 | |
| Sanofi-Aventis Investigational Site Number 250002 | |
| Villejuif Cedex, France, 94805 | |
Sponsors and Collaborators
Sanofi
Investigators
| Principal Investigator: | Bertrand COIFFIER, Professor of Hematology | Centre Hospitalier Lyon Sud, France |
More Information
No publications provided
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT00796731 History of Changes |
| Other Study ID Numbers: | TED6829, EudraCT 2007-004868-41 |
| Study First Received: | November 21, 2008 |
| Last Updated: | July 16, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Sanofi:
|
B-cell lymphoma NHL |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Lymphoma, B-Cell Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013