SAR3419 as Single Agent in Relapsed-Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Patients

Diffuse Large B-cell Lymphoma Clinical Trial

— STARLYTE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01472887
• Other study ID #: ARD10248
• Secondary ID: 2011-003657-26U1
• Status: Completed
• Phase: Phase 2
• First received: November 14, 2011
• Last updated: January 18, 2018
• Start date: January 2012
• Est. completion date: September 2016

Study information

• Verified date: January 2018
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Primary Objective:

Participants achieving an Objective Response Rate

Secondary Objective:

• Progression Free Survival

• Overall Survival

• Response Duration

• Safety

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• SAR3419
Pharmaceutical form:concentrate for solution for infusion Route of administration: intravenous

Locations

Country	Name	City	State
Belgium	Investigational Site Number 056002	Gent
Belgium	Investigational Site Number 056001	Leuven
Czechia	Investigational Site Number 203002	Brno
Czechia	Investigational Site Number 203003	Praha 10
Czechia	Investigational Site Number 203001	Praha 2
Israel	Investigational Site Number 376003	Jerusalem
Israel	Investigational Site Number 376002	Tel Hashomer
Italy	Investigational Site Number 380002	Bergamo
Italy	Investigational Site Number 380004	Bologna
Italy	Investigational Site Number 380008	Mestre
Italy	Investigational Site Number 380001	Milano
Italy	Investigational Site Number 380007	Modena
Italy	Investigational Site Number 380003	Palermo
Italy	Investigational Site Number 380006	Pavia
Poland	Investigational Site Number 616003	Brzozow
Poland	Investigational Site Number 616002	Kielce
Poland	Investigational Site Number 616001	Warszawa
Spain	Investigational Site Number 724002	Barcelona
Spain	Investigational Site Number 724004	Barcelona
Spain	Investigational Site Number 724001	Madrid
Spain	Investigational Site Number 724003	Valencia
Turkey	Investigational Site Number 792001	Izmir
Turkey	Investigational Site Number 792003	Izmir
United Kingdom	Investigational Site Number 826001	Leicester
United Kingdom	Investigational Site Number 826002	Manchester
United States	Investigational Site Number 840003	Augusta	Georgia
United States	Investigational Site Number 840005	Boise	Idaho
United States	Investigational Site Number 840001	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Belgium,  Czechia,  Israel,  Italy,  Poland,  Spain,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants achieving an Objective Response Rate		18 months
Secondary	Number of participants with Adverse Events		Up to 1 year
Secondary	Response duration - Time		Up to 18 months after the first infusion of the last patient
Secondary	Progression Free Survival - Time		Up to 18 months after the first infusion of the last patient
Secondary	Overall Survival - Time		Up to 18 months after the first infusion of the last patient