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

Primary Purpose

Diffuse Large B-cell Lymphoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SAR3419
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diffuse Large B-cell Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigational Site Number 840001
  • Investigational Site Number 840003
  • Investigational Site Number 840005
  • Investigational Site Number 056002
  • Investigational Site Number 056001
  • Investigational Site Number 203002
  • Investigational Site Number 203003
  • Investigational Site Number 203001
  • Investigational Site Number 376003
  • Investigational Site Number 376002
  • Investigational Site Number 380002
  • Investigational Site Number 380004
  • Investigational Site Number 380008
  • Investigational Site Number 380001
  • Investigational Site Number 380007
  • Investigational Site Number 380003
  • Investigational Site Number 380006
  • Investigational Site Number 616003
  • Investigational Site Number 616002
  • Investigational Site Number 616001
  • Investigational Site Number 724002
  • Investigational Site Number 724004
  • Investigational Site Number 724001
  • Investigational Site Number 724003
  • Investigational Site Number 792003
  • Investigational Site Number 792001
  • Investigational Site Number 826001
  • Investigational Site Number 826002

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SAR3419

Arm Description

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

Outcomes

Primary Outcome Measures

Number of participants achieving an Objective Response Rate

Secondary Outcome Measures

Number of participants with Adverse Events
Response duration - Time
Progression Free Survival - Time
Overall Survival - Time

Full Information

First Posted
November 14, 2011
Last Updated
January 18, 2018
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT01472887
Brief Title
SAR3419 as Single Agent in Relapsed-Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Patients
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B-cell Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SAR3419
Arm Type
Experimental
Arm Description
All patients will receive SAR3419 until evidence of disease progression, unacceptable toxicity, or other reasons for therapy discontinuation
Intervention Type
Drug
Intervention Name(s)
SAR3419
Intervention Description
Pharmaceutical form:concentrate for solution for infusion Route of administration: intravenous
Primary Outcome Measure Information:
Title
Number of participants achieving an Objective Response Rate
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Number of participants with Adverse Events
Time Frame
Up to 1 year
Title
Response duration - Time
Time Frame
Up to 18 months after the first infusion of the last patient
Title
Progression Free Survival - Time
Time Frame
Up to 18 months after the first infusion of the last patient
Title
Overall Survival - Time
Time Frame
Up to 18 months after the first infusion of the last patient

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 840001
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Investigational Site Number 840003
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Investigational Site Number 840005
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
Investigational Site Number 056002
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Investigational Site Number 056001
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Investigational Site Number 203002
City
Brno
ZIP/Postal Code
62500
Country
Czechia
Facility Name
Investigational Site Number 203003
City
Praha 10
ZIP/Postal Code
10034
Country
Czechia
Facility Name
Investigational Site Number 203001
City
Praha 2
ZIP/Postal Code
12808
Country
Czechia
Facility Name
Investigational Site Number 376003
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Investigational Site Number 376002
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Investigational Site Number 380002
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
Investigational Site Number 380004
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Investigational Site Number 380008
City
Mestre
ZIP/Postal Code
30174
Country
Italy
Facility Name
Investigational Site Number 380001
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Investigational Site Number 380007
City
Modena
ZIP/Postal Code
41100
Country
Italy
Facility Name
Investigational Site Number 380003
City
Palermo
ZIP/Postal Code
90145
Country
Italy
Facility Name
Investigational Site Number 380006
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Investigational Site Number 616003
City
Brzozow
ZIP/Postal Code
36-200
Country
Poland
Facility Name
Investigational Site Number 616002
City
Kielce
ZIP/Postal Code
25-734
Country
Poland
Facility Name
Investigational Site Number 616001
City
Warszawa
ZIP/Postal Code
04-141
Country
Poland
Facility Name
Investigational Site Number 724002
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Investigational Site Number 724004
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Investigational Site Number 724001
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Investigational Site Number 724003
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Investigational Site Number 792003
City
Izmir
ZIP/Postal Code
35040
Country
Turkey
Facility Name
Investigational Site Number 792001
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Investigational Site Number 826001
City
Leicester
Country
United Kingdom
Facility Name
Investigational Site Number 826002
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
29748443
Citation
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.
Results Reference
derived

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

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