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

NCT ID: NCT01472887

Last Updated: 2018-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2016-09-30

Brief Summary

Primary Objective:

Participants achieving an Objective Response Rate

Secondary Objective:

• Progression Free Survival
• Overall Survival
• Response Duration
• Safety

Detailed 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.

Conditions

Diffuse Large B-cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SAR3419

All patients will receive SAR3419 until evidence of disease progression, unacceptable toxicity, or other reasons for therapy discontinuation

Group Type: EXPERIMENTAL

SAR3419

Intervention Type: DRUG

Pharmaceutical form:concentrate for solution for infusion

Route of administration: intravenous

Interventions

SAR3419

Pharmaceutical form:concentrate for solution for infusion

Route of administration: intravenous

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 840001

Denver, Colorado, United States

Investigational Site Number 840003

Augusta, Georgia, United States

Investigational Site Number 840005

Boise, Idaho, United States

Investigational Site Number 056002

Ghent, , Belgium

Investigational Site Number 056001

Leuven, , Belgium

Investigational Site Number 203002

Brno, , Czechia

Investigational Site Number 203003

Prague, , Czechia

Investigational Site Number 203001

Prague, , Czechia

Investigational Site Number 376003

Jerusalem, , Israel

Investigational Site Number 376002

Tel Litwinsky, , Israel

Investigational Site Number 380002

Bergamo, , Italy

Investigational Site Number 380004

Bologna, , Italy

Investigational Site Number 380008

Mestre, , Italy

Investigational Site Number 380001

Milan, , Italy

Investigational Site Number 380007

Modena, , Italy

Investigational Site Number 380003

Palermo, , Italy

Investigational Site Number 380006

Pavia, , Italy

Investigational Site Number 616003

Brzozów, , Poland

Investigational Site Number 616002

Kielce, , Poland

Investigational Site Number 616001

Warsaw, , Poland

Investigational Site Number 724002

Barcelona, , Spain

Investigational Site Number 724004

Barcelona, , Spain

Investigational Site Number 724001

Madrid, , Spain

Investigational Site Number 724003

Valencia, , Spain

Investigational Site Number 792003

Izmir, , Turkey (Türkiye)

Investigational Site Number 792001

Izmir, , Turkey (Türkiye)

Investigational Site Number 826001

Leicester, , United Kingdom

Investigational Site Number 826002

Manchester, , United Kingdom

Countries

United States; Belgium; Czechia; Israel; Italy; Poland; Spain; Turkey (Türkiye); United Kingdom

References

Trneny M, Verhoef G, Dyer MJ, Ben Yehuda D, Patti C, Canales M, Lopez A, Awan FT, Montgomery PG, Janikova A, Barbui AM, Sulek K, Terol MJ, Radford J, Guidetti A, Di Nicola M, Siraudin L, Hatteville L, Schwab S, Oprea C, Gianni AM. A phase II multicenter study of the anti-CD19 antibody drug conjugate coltuximab ravtansine (SAR3419) in patients with relapsed or refractory diffuse large B-cell lymphoma previously treated with rituximab-based immunotherapy. Haematologica. 2018 Aug;103(8):1351-1358. doi: 10.3324/haematol.2017.168401. Epub 2018 May 10.

Reference Type: DERIVED

PMID: 29748443 (View on PubMed)

Other Identifiers

2011-003657-26

Identifier Type: -

Identifier Source: secondary_id

U1111-1115-3349

Identifier Type: OTHER

Identifier Source: secondary_id

ARD10248

Identifier Type: -

Identifier Source: org_study_id