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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)


Phase 1
18 Years
N/A
Not Enrolling
Both
Lymphoma, Non-Hodgkin

Thank you

Trial Information

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)


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of Dose Limiting Toxicity(ies) at each tested dose level

Outcome Time Frame:

Study period

Safety Issue:

Yes

Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

United States: Food and Drug Administration

Study ID:

TED6828

NCT ID:

NCT00549185

Start Date:

October 2007

Completion Date:

January 2012

Related Keywords:

  • Lymphoma
  • Non-Hodgkin
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell

Name

Location

Sanofi-Aventis Administrative OfficeBridgewater, New Jersey  08807