Clinical trial NCT01472887: SAR3419 as Single Agent in Relapsed-Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Patients
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diffuse Large B-cell Lymphoma
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2011-11-17
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of participants achieving an Objective Response Rate
timeFrame: 18 months
Secondary outcomes:
measure: Number of participants with Adverse Events
timeFrame: Up to 1 year
measure: Response duration - Time
timeFrame: Up to 18 months after the first infusion of the last patient
measure: Progression Free Survival - Time
timeFrame: Up to 18 months after the first infusion of the last patient
measure: Overall Survival - Time
timeFrame: Up to 18 months after the first infusion of the last patient
Other outcomes:
Locations:
city: Denver
country: United States
facility: Investigational Site Number 840001
state: Colorado
city: Augusta
country: United States
facility: Investigational Site Number 840003
state: Georgia
city: Boise
country: United States
facility: Investigational Site Number 840005
state: Idaho
city: Gent
country: Belgium
facility: Investigational Site Number 056002
city: Leuven
country: Belgium
facility: Investigational Site Number 056001
city: Brno
country: Czechia
facility: Investigational Site Number 203002
city: Praha 10
country: Czechia
facility: Investigational Site Number 203003
city: Praha 2
country: Czechia
facility: Investigational Site Number 203001
city: Jerusalem
country: Israel
facility: Investigational Site Number 376003
city: Tel Hashomer
country: Israel
facility: Investigational Site Number 376002
city: Bergamo
country: Italy
facility: Investigational Site Number 380002
city: Bologna
country: Italy
facility: Investigational Site Number 380004
city: Mestre
country: Italy
facility: Investigational Site Number 380008
city: Milano
country: Italy
facility: Investigational Site Number 380001
city: Modena
country: Italy
facility: Investigational Site Number 380007
city: Palermo
country: Italy
facility: Investigational Site Number 380003
city: Pavia
country: Italy
facility: Investigational Site Number 380006
city: Brzozow
country: Poland
facility: Investigational Site Number 616003
city: Kielce
country: Poland
facility: Investigational Site Number 616002
city: Warszawa
country: Poland
facility: Investigational Site Number 616001
city: Barcelona
country: Spain
facility: Investigational Site Number 724002
city: Barcelona
country: Spain
facility: Investigational Site Number 724004
city: Madrid
country: Spain
facility: Investigational Site Number 724001
city: Valencia
country: Spain
facility: Investigational Site Number 724003
city: Izmir
country: Turkey
facility: Investigational Site Number 792003
city: Izmir
country: Turkey
facility: Investigational Site Number 792001
city: Leicester
country: United Kingdom
facility: Investigational Site Number 826001
city: Manchester
country: United Kingdom
facility: Investigational Site Number 826002
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
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.