Resminostat for Maintenance Treatment of Patients With Advanced Stage Mycosis Fungoides (MF) or Sézary Syndrome (SS)
- Conditions
- Sezary SyndromeLymphoma, T-Cell, CutaneousMycosis Fungoides
- Interventions
- Drug: Placebo
- Registration Number
- NCT02953301
- Lead Sponsor
- 4SC AG
- Brief Summary
The purpose of this study is to determine whether resminostat will be able to delay or prevent worsening of disease in patients with advanced stage mycosis fungoides or Sézary Syndrome that have recently achieved disease control with previous systemic therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 201
- Patients with histologically confirmed MF (Stage IIB-IVB) or SS in an ongoing complete response (CR), partial response (PR) or stable disease (SD) after at least one prior systemic therapy according to local standards (including but not limited to α-interferon, bexarotene, total skin electron beam irradiation, chemotherapy) [the most recent systemic therapy must have been completed as planned or stopped due to unacceptable toxicity 2-12 weeks prior to randomisation]
- Eastern Cooperative Oncology Group (ECOG) status score 0-2
- Adequate haematological, hepatic and renal function
Main
- Patients with progressive disease (PD)
- Baseline corrected QT (QTc) interval > 500 milliseconds
- Concurrent use of any other specific anti-tumour therapy including psoralen photo chemotherapy (PUVA), chemotherapy, immunotherapy, hormonal therapy, radiation therapy, or experimental medications
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo 3 tablets p.o. matching verum, 5 days treatment followed by 9 days rest (cycles until progress or unacceptable toxicity) resminostat resminostat 3 x 200 mg tablets p.o., 5 days treatment followed by 9 days rest (cycles until progress or unacceptable toxicity)
- Primary Outcome Measures
Name Time Method PFS (Progression-free survival) From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, up to approximately 32 months The primary objective is to determine if maintenance treatment with resminostat increases progression free survival (PFS) compared to placebo in patients with advanced stage (Stage IIB-IVB) MF or SS that have achieved disease control (complete response \[CR\], partial response \[PR\] or stable disease \[SD\]) with previous systemic therapy.
- Secondary Outcome Measures
Name Time Method TTSW (Time to symptom worsening): pruritus From date of randomisation to first date that criteria for symptom (pruritus) worsening have been met, up to approximately 32 months. Symptom worsening is defined as an increase of a minimum of 3 points on the visual analogue itching scale To determine if maintenance treatment with resminostat increases time to symptom (pruritus) worsening (TTSW) compared to placebo.
Trial Locations
- Locations (54)
Okayama University Hospital
🇯🇵Okayama, Japan
Uniwersytecki Szpital Kliniczny im. WAM - CSW
🇵🇱Łódź, Poland
ATTIKON Hospital and Cutaneous Lymphoma Clinic
🇬🇷Athens, Greece
Niigata University Medical and Dental Hospital
🇯🇵Niigata, Japan
Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie
🇵🇱Warsaw, Poland
Universitaire Ziekenhuizen
🇧🇪Leuven, Belgium
Universitaetsklinikum Halle
🇩🇪Halle (Saale), Germany
Universitaetsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Universitätsklinikum Schleswig-Holstein
🇩🇪Lübeck, Germany
Johannes Wesling Klinikum Minden
🇩🇪Minden, Germany
Universita Cattolica del Sacro Cuore
🇮🇹Roma, Italy
Medical University of Gdansk
🇵🇱Gdansk, Poland
Centre Hospitalier Universitaire (CHU) de Bordeaux - Hôpital Saint-André
🇫🇷Bordeaux, France
Hopital Robert Debre - CHU de Reims
🇫🇷Reims, France
Centre Hospitalier Lyon-Sud
🇫🇷Lyon, France
Chu Paris-Gh St-Louis Lariboisiere F.Widal Hopital
🇫🇷Paris, France
Universitaetsklinikum Bochum - St. Josef-Hospital
🇩🇪Bochum, Germany
CHU Estaing
🇫🇷Clermont-Ferrand, France
Elbekliniken Buxtehude
🇩🇪Buxtehude, Germany
Charité - Universitaetsmedizin Berlin
🇩🇪Berlin, Germany
Uniklinik Köln
🇩🇪Cologne, Germany
Klinikum Dortmund
🇩🇪Dortmund, Germany
SRH Wald-Klinikum Gera
🇩🇪Gera, Germany
Universitätsmedizin Göttingen
🇩🇪Göttingen, Germany
Universitäts-Hautklinik Tübingen
🇩🇪Tübingen, Germany
Universitaetsklinikum Schleswig-Holstein (UKSH), Campus Kiel
🇩🇪Kiel, Germany
HELIOS Klinikum
🇩🇪Krefeld, Germany
Klinikum der Stadt Ludwigshafen am Rhein
🇩🇪Ludwigshafen am Rhein, Germany
Universitätsklinikum Mannheim
🇩🇪Mannheim, Germany
Ospedale Molinette
🇮🇹Turin, Italy
Universita Di Firenze
🇮🇹Firenze, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
🇮🇹Milano, Italy
Universitätsklinikum Ulm
🇩🇪Ulm, Germany
IFO San Gallicano
🇮🇹Rome, Italy
Tohoku University Hospital
🇯🇵Sendai, Japan
Hospital Uni. Nuestra Senora de Candelaria
🇪🇸Tenerife, Spain
Hospital Del Mar
🇪🇸Barcelona, Spain
Hospital General Universitario
🇪🇸Valencia, Spain
Hospital Duran i Reynals
🇪🇸Barcelona, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
University Hospital
🇬🇧Birmingham, United Kingdom
Beatson West of Scotland Cancer Centre
🇬🇧Glasgow, United Kingdom
St John's Institute Of Dermatology - Guy's & St Thomas' Nhs Foundation Trust
🇬🇧London, United Kingdom
Centre hospitalier universitaire vaudois (CHUV)
🇨🇭Lausanne, Switzerland
Universitätsspital Zürich
🇨🇭Zürich, Switzerland
Christie Hospital
🇬🇧Manchester, United Kingdom
Medizinische Universität Graz
🇦🇹Graz, Austria
Medizinische Universität Wien
🇦🇹Wien, Austria
Cliniques Universitaires Saint-Luc
🇧🇪Bruxelles, Belgium
Hamamatsu University School of Medicine
🇯🇵Shizuoka, Japan
Leids Universitair Medisch Centrum (LUMC)
🇳🇱Leiden, Netherlands
SP ZOZ Szpital Uniwersytecki w Krakowie
🇵🇱Kraków, Poland
University of Tsukuba Hospital
🇯🇵Tsukuba, Japan
Kantonsspital St. Gallen
🇨🇭St. Gallen, Switzerland