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The purpose of this study is to determine whether Resminostat (4SC-201) is effective and safe in the treatment of relapsed or refractory Hodgkin's Lymphoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resminostat (4SC-201) | Experimental | oral administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resminostat (4SC-201) | Drug | oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determination of the best overall objective response rate (ORR) based on IWG criteria of Resminostat (4SC-201) in patients with refractory or relapsed Hodgkin's Lymphoma. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Investigation of the safety and tolerability of repeated oral doses of Resminostat (4SC-201) | 12 weeks | |
| Assessment of the overall survival (OS) | 12 weeks | |
| Determination of progression free survival (PFS), including radiological and symptomatic progression |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Walewski, Prof. | Instytut im. Marii Skłodowskiej-Curie, Centrum Onkologii, Warsaw, Poland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fakultní nemocnice Brno | Brno | Czechia | ||||
| Fakultní nemocnice Hradec Kralové |
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| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| C550599 | resminostat |
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| 12 weeks |
| Determination of time to progression (TTP), including objective and symptomatic progression | 12 weeks |
| Determination of duration of response (DOR) | 12 weeks |
| Assessment of the pharmacokinetics of Resminostat (4SC-201) after oral dosing | 12 weeks |
| Hradec Kralové |
| Czechia |
| Fakultní nemocnice Kralovske Vinohrady | Prague | Czechia |
| Uniwersyteckie Centrum Kliniczne | Gdansk | Poland |
| Samodzielny Publiczny Szpital Kliniczny Nr.1 w Poznaniu | Poznan | Poland |
| Instytut im. Marii Sklodowskiej-Curie, Centrum Onkologii | Warsaw | Poland |
| Wojskowy Instytut Medyczny | Warsaw | Poland |
| Samodzielny Publiczny Szpital Kliniczny Nr.1 we Wroclawiu | Wroclaw | Poland |
| Institutul Clinic Fundeni | Bucharest | Romania |
| Spitalul Clinic Coltea | Bucharest | Romania |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |