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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-003657-26 | |||
| U1111-1115-3349 | Other Identifier | UTN |
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Primary Objective:
Participants achieving an Objective Response Rate
Secondary Objective:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAR3419 | Experimental | All patients will receive SAR3419 until evidence of disease progression, unacceptable toxicity, or other reasons for therapy discontinuation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAR3419 | Drug | Pharmaceutical form:concentrate for solution for infusion Route of administration: intravenous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants achieving an Objective Response Rate | 18 months |
| Measure | Description | 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 |
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Inclusion criteria:
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 840001 | Denver | Colorado | 80262 | United States | ||
| Investigational Site Number 840003 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29748443 | Derived | 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. |
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| 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 |
| Augusta |
| Georgia |
| 30912 |
| United States |
| Investigational Site Number 840005 | Boise | Idaho | 83712 | United States |
| Investigational Site Number 056002 | Ghent | 9000 | Belgium |
| Investigational Site Number 056001 | Leuven | 3000 | Belgium |
| Investigational Site Number 203002 | Brno | 62500 | Czechia |
| Investigational Site Number 203003 | Prague | 10034 | Czechia |
| Investigational Site Number 203001 | Prague | 12808 | Czechia |
| Investigational Site Number 376003 | Jerusalem | 91120 | Israel |
| Investigational Site Number 376002 | Tel Litwinsky | 52621 | Israel |
| Investigational Site Number 380002 | Bergamo | 24127 | Italy |
| Investigational Site Number 380004 | Bologna | 40138 | Italy |
| Investigational Site Number 380008 | Mestre | 30174 | Italy |
| Investigational Site Number 380001 | Milan | 20133 | Italy |
| Investigational Site Number 380007 | Modena | 41100 | Italy |
| Investigational Site Number 380003 | Palermo | 90145 | Italy |
| Investigational Site Number 380006 | Pavia | 27100 | Italy |
| Investigational Site Number 616003 | Brzozów | 36-200 | Poland |
| Investigational Site Number 616002 | Kielce | 25-734 | Poland |
| Investigational Site Number 616001 | Warsaw | 04-141 | Poland |
| Investigational Site Number 724002 | Barcelona | 08003 | Spain |
| Investigational Site Number 724004 | Barcelona | 08035 | Spain |
| Investigational Site Number 724001 | Madrid | 28046 | Spain |
| Investigational Site Number 724003 | Valencia | 46010 | Spain |
| Investigational Site Number 792003 | Izmir | 35040 | Turkey (Türkiye) |
| Investigational Site Number 792001 | Izmir | 35340 | Turkey (Türkiye) |
| Investigational Site Number 826001 | Leicester | United Kingdom |
| Investigational Site Number 826002 | Manchester | M20 4BX | United Kingdom |
| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C569646 | coltuximab ravtansine |
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