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An Open Label Non-Randomized Phase 2 Study Evaluating SAR3419, an Anti-CD19 Antibody - Maytansine Conjugate, Administered as Single Agent by Intravenous Infusion to Patients With Relapsed or Refractory CD19+ Diffuse Large B-Cell Lymphoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Diffuse Large B-cell Lymphoma

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Trial Information

An Open Label Non-Randomized Phase 2 Study Evaluating SAR3419, an Anti-CD19 Antibody - Maytansine Conjugate, Administered as Single Agent by Intravenous Infusion to Patients With Relapsed or Refractory CD19+ Diffuse Large B-Cell Lymphoma


The screening period = up to 4 weeks prior to SAR3419 administration

The treatment period = from the day of first administration of SAR3419 until the
End-Of-Treatment visit. All patients will receive SAR3419 until evidence of disease
progression, unacceptable toxicity or other reasons for therapy discontinuation - After
therapy discontinuation all patients will enter a safety follow-up period of 42 days
starting from the day of administration of the last dose of SAR3419 and ending with the End
Of Treatment visit.

All patients, regardless whether they have progressed or not, will be followed until death
or end of study to evaluate survival for at least 18 months.

Inclusion Criteria


Inclusion criteria:

- Histological diagnosis of Diffuse Large B Cell Lymphoma (de novo or transformed)
expressing CD19 by immunohistochemistry or flow cytometry analysis (>30% positivity),
based on recent (less than 6 months) or new biopsy.

- At least 1 prior specific therapeutic regimen, one of which should have included
rituximab (patients previously eligible for transplantation: the salvage treatment
followed by intensification and Autologous Stem Cell Transplant (ASCT) will be
considered one regimen).

- Relapsed disease after standard 1st line therapy for aggressive lymphoma - not
eligible for high dose chemotherapy with stem cell support. Relapsed or refractory
disease after two lines of therapy one of which could have included Autologous Stem
Cell Transplant (ASCT). Relapsed disease is defined as progression after a disease
free interval of at least 6 months after completion of last therapy. Refractory is
defined as progression of disease during prior therapy or within 6 months from its
completion.

- Available paraffin-embedded tissue should have been collected no longer than 6 months
prior to first administration of SAR3419. Cryo-preserved tissue cannot be used. If
archival material is not available, a Fine Needle Aspiration (FNA) must be obtained.

Exclusion criteria:

- Primary refractory patients

- Patients with primary mediastinal DLBCL

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: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of participants achieving an Objective Response Rate

Outcome Time Frame:

18 months

Safety Issue:

No

Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

United States: Food and Drug Administration

Study ID:

ARD10248

NCT ID:

NCT01472887

Start Date:

January 2012

Completion Date:

February 2015

Related Keywords:

  • Diffuse Large B-Cell Lymphoma
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse

Name

Location

Investigational Site Number 840002Atlanta, Georgia  30322
Investigational Site Number 840003Augusta, Georgia  30912
Investigational Site Number 840005Boise, Idaho  83712