A multicentre, double blind, randomized, placebo controlled, Phase II trial to evaluate Resminostat for maintenance treatment of patients with advanced stage (Stage IIB-IVB) mycosis fungoides (MF) or Sézary Syndrome (SS) that have achieved disease control with systemic therapy – the RESMAIN Study
Rudolf Stadler1, Julia Scarisbrick2, Robert Knobler3, Pietro Quaglino4, Matthias Borgmann5, Martin Orlovius5, Babett Krauss5, Susanne Danhauser-Riedl5
1 University Hospital of Dermatology, Minden, Germany, 2 University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK, 3 Medical University of Vienna, Vienna, Austria, 4 University of Turin, Turin, Italy, 5 4SC AG, Planegg-Martinsried, Germany
CTCL is characterized by the presence of a clonal T-cell population in the skin and/or blood, lymph nodes or visceral organs. Patients with early disease can be treated effectively with topical treatments. However, a key challenge is, to achieve durable remissions in patients with advanced disease, who require systemic treatment. In malignant T cells of CTCL, epigenetic alterations are known to play a key role in pathogenesis. Resminostat is an orally available HDAC inhibitor, which induces changes in gene expression resulting in growth inhibition, modified cell differentiation and enhanced tumor immunogenicity. The purpose of the RESMAIN study is, to investigate resminostat as maintenance treatment for patients with advanced stage mycosis fungoides (MF) or Sézary Syndrome (SS) that have achieved disease control with systemic therapy.
Key Inclusion Criteria:
Key Exclusion Criteria:
Key secondary objective:
Further objectives include TTP, TTNT, ORR, OS, PK, Safety and HrQoL and comprehensive biomarker evaluation.
To our knowledge, this is the first randomized study that investigates an HDAC inhibitor as maintenance therapy in advanced-stage CTCL.