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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
201
PFS (Progression-free survival)
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.
Time frame: 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
TTSW (Time to symptom worsening): pruritus
To determine if maintenance treatment with resminostat increases time to symptom (pruritus) worsening (TTSW) compared to placebo.
Time frame: 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
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Medizinische Universität Graz
Graz, Austria
Medizinische Universität Wien
Vienna, Austria
Cliniques Universitaires Saint-Luc
Brussels, Belgium
Universitaire Ziekenhuizen
Leuven, Belgium
Centre Hospitalier Universitaire (CHU) de Bordeaux - Hôpital Saint-André
Bordeaux, France
CHU Estaing
Clermont-Ferrand, France
Centre Hospitalier Lyon-Sud
Lyon, France
Chu Paris-Gh St-Louis Lariboisiere F.Widal Hopital
Paris, France
Hopital Robert Debre - CHU de Reims
Reims, France
Charité - Universitaetsmedizin Berlin
Berlin, Germany
...and 44 more locations