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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
oral administration
Fakultní nemocnice Brno
Brno, Czechia
Fakultní nemocnice Hradec Kralové
Hradec Kralové, Czechia
Fakultní nemocnice Kralovske Vinohrady
Prague, Czechia
Uniwersyteckie Centrum Kliniczne
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.
Time frame: 12 weeks
Investigation of the safety and tolerability of repeated oral doses of Resminostat (4SC-201)
Time frame: 12 weeks
Assessment of the overall survival (OS)
Time frame: 12 weeks
Determination of progression free survival (PFS), including radiological and symptomatic progression
Time frame: 12 weeks
Determination of time to progression (TTP), including objective and symptomatic progression
Time frame: 12 weeks
Determination of duration of response (DOR)
Time frame: 12 weeks
Assessment of the pharmacokinetics of Resminostat (4SC-201) after oral dosing
Time frame: 12 weeks
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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