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

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

Primary Objective:

Participants achieving an Objective Response Rate

Secondary Objective:

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

Study Overview

• Status: Completed
• Conditions: Diffuse Large B-cell Lymphoma
• Intervention / Treatment: Drug: SAR3419

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.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Gent, Belgium, 9000
    • Investigational Site Number 056002
  • Leuven, Belgium, 3000
    • Investigational Site Number 056001
• Czechia
  • Brno, Czechia, 62500
    • Investigational Site Number 203002
  • Praha 10, Czechia, 10034
    • Investigational Site Number 203003
  • Praha 2, Czechia, 12808
    • Investigational Site Number 203001
• Israel
  • Jerusalem, Israel, 91120
    • Investigational Site Number 376003
  • Tel Hashomer, Israel, 52621
    • Investigational Site Number 376002
• Italy
  • Bergamo, Italy, 24127
    • Investigational Site Number 380002
  • Bologna, Italy, 40138
    • Investigational Site Number 380004
  • Mestre, Italy, 30174
    • Investigational Site Number 380008
  • Milano, Italy, 20133
    • Investigational Site Number 380001
  • Modena, Italy, 41100
    • Investigational Site Number 380007
  • Palermo, Italy, 90145
    • Investigational Site Number 380003
  • Pavia, Italy, 27100
    • Investigational Site Number 380006
• Poland
  • Brzozow, Poland, 36-200
    • Investigational Site Number 616003
  • Kielce, Poland, 25-734
    • Investigational Site Number 616002
  • Warszawa, Poland, 04-141
    • Investigational Site Number 616001
• Spain
  • Barcelona, Spain, 08035
    • Investigational Site Number 724004
  • Barcelona, Spain, 08003
    • Investigational Site Number 724002
  • Madrid, Spain, 28046
    • Investigational Site Number 724001
  • Valencia, Spain, 46010
    • Investigational Site Number 724003
• Turkey
  • Izmir, Turkey, 35340
    • Investigational Site Number 792001
  • Izmir, Turkey, 35040
    • Investigational Site Number 792003
• United Kingdom
  • Leicester, United Kingdom
    • Investigational Site Number 826001
  • Manchester, United Kingdom, M20 4BX
    • Investigational Site Number 826002
• United States
  • Colorado
    • Denver, Colorado, United States, 80262
      • Investigational Site Number 840001
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Investigational Site Number 840003
  • Idaho
    • Boise, Idaho, United States, 83712
      • Investigational Site Number 840005

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SAR3419; All patients will receive SAR3419 until evidence of disease progression, unacceptable toxicity, or other reasons for therapy discontinuation	Drug: SAR3419; Pharmaceutical form:concentrate for solution for infusion Route of administration: intravenous

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants achieving an Objective Response Rate	18 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Sanofi

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: November 14, 2011
• First Submitted That Met QC Criteria: November 14, 2011
• First Posted (Estimate): November 17, 2011

Study Record Updates

• Last Update Posted (Actual): January 25, 2018
• Last Update Submitted That Met QC Criteria: January 18, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
• Other Study ID Numbers: ARD10248; 2011-003657-26; U1111-1115-3349 (Other Identifier: UTN)