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

NCT01472887 | Completed Phase 2

• 3 other identifiers: ARD102482011-003657-26U1111-1115-3349
• Study Type: interventional
• Target: 61
• Locations: 9 countries
• Sites: 28

Brief Summary

Primary Objective: Participants achieving an Objective Response Rate Secondary Objective:

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

Conditions

Diffuse Large B-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Number of participants achieving an Objective Response Rate

  18 months

Secondary Outcomes (4)

• Number of participants with Adverse Events

  Up to 1 year

• Response duration - Time

  Up to 18 months after the first infusion of the last patient

• Progression Free Survival - Time

  Up to 18 months after the first infusion of the last patient

• Overall Survival - Time

  Up to 18 months after the first infusion of the last patient

Study Arms (1)

SAR3419

EXPERIMENTAL

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

Drug: SAR3419

Interventions

SAR3419 DRUG

Pharmaceutical form:concentrate for solution for infusion Route of administration: intravenous

SAR3419

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (28)

Investigational Site Number 840001

Denver, Colorado, 80262, United States

Location

Investigational Site Number 840003

Augusta, Georgia, 30912, United States

Location

Investigational Site Number 840005

Boise, Idaho, 83712, United States

Location

Investigational Site Number 056002

Ghent, 9000, Belgium

Location

Investigational Site Number 056001

Leuven, 3000, Belgium

Location

Investigational Site Number 203002

Brno, 62500, Czechia

Location

Investigational Site Number 203003

Prague, 10034, Czechia

Location

Investigational Site Number 203001

Prague, 12808, Czechia

Location

Investigational Site Number 376003

Jerusalem, 91120, Israel

Location

Investigational Site Number 376002

Tel Litwinsky, 52621, Israel

Location

Investigational Site Number 380002

Bergamo, 24127, Italy

Location

Investigational Site Number 380004

Bologna, 40138, Italy

Location

Investigational Site Number 380008

Mestre, 30174, Italy

Location

Investigational Site Number 380001

Milan, 20133, Italy

Location

Investigational Site Number 380007

Modena, 41100, Italy

Location

Investigational Site Number 380003

Palermo, 90145, Italy

Location

Investigational Site Number 380006

Pavia, 27100, Italy

Location

Investigational Site Number 616003

Brzozów, 36-200, Poland

Location

Investigational Site Number 616002

Kielce, 25-734, Poland

Location

Investigational Site Number 616001

Warsaw, 04-141, Poland

Location

Investigational Site Number 724002

Barcelona, 08003, Spain

Location

Investigational Site Number 724004

Barcelona, 08035, Spain

Location

Investigational Site Number 724001

Madrid, 28046, Spain

Location

Investigational Site Number 724003

Valencia, 46010, Spain

Location

Investigational Site Number 792003

Izmir, 35040, Turkey (Türkiye)

Location

Investigational Site Number 792001

Izmir, 35340, Turkey (Türkiye)

Location

Investigational Site Number 826001

Leicester, United Kingdom

Location

Investigational Site Number 826002

Manchester, M20 4BX, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 29748443 DERIVED

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

coltuximab ravtansine

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2011
• First Posted: November 17, 2011
• Study Start: January 1, 2012
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: January 25, 2018

Record last verified: 2018-01

Locations

US (3); TU (2); BE (2); IT (7); GB (2); CZ (3); IL (2); PL (3); ES (4)