NCT02953301.

Study name	A multicentre, double blind, randomised, 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 Tterapy ‐ the RESMAIN study
Methods	This is a randomised, controlled trial comparing resminostat vs. placebo in patients with advanced stage mycosis fungoides (MF) or Sézary syndrome (SS)
Participants	Inclusion criteria Age: 18 or older 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) Exclusion criteria Patients with progressive disease (PD) Concurrent use of any other specific anti‐tumour therapy including psoralen photo chemotherapy (PUVA), chemotherapy, immunotherapy, hormonal therapy, radiation therapy, or experimental medications
Interventions	Arm I Resminostat 3 x 200 mg tablets orally, 5 days treatment followed by 9 days rest (cycles until progress or unacceptable toxicity) Arm II Placebo 3 tablets orally matching verum, 5 days treatment followed by 9 days rest (cycles until progress or unacceptable toxicity)
Outcomes	Primary outcomes of the study Progression‐free survival (PFS) The primary objective is to determine if maintenance treatment with resminostat increases PFS compared to placebo in patients with advanced stage (Stage IIB‐IVB) MF or SS who have achieved disease control (complete response (CR) partial response (PR) or stable disease (SD)) with previous systemic therapy Secondary outcomes of the study Time to symptom worsening (TTSW): pruritus To determine if maintenance treatment with resminostat increases TTSW (pruritus) compared to placebo
Starting date	November 2016
Contact information	Sponsors and collaborators 4SC AG Investigators Principal Investigator: Rudolf Stadler, Prof. Johannes Wesling Klinikum, Minden, Germany
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