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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)


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

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Trial Information

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)


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Incidence of DLT(s) at each dose level

Outcome Time Frame:

during the initial 3-week period of treatment

Safety Issue:

Yes

Principal Investigator

Bertrand COIFFIER, Professor of Hematology

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Hospitalier Lyon Sud, France

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

TED6829

NCT ID:

NCT00796731

Start Date:

October 2008

Completion Date:

June 2012

Related Keywords:

  • Lymphoma
  • Non-Hodgkin
  • B-cell lymphoma
  • NHL
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell

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