RESMAIN (FL)

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 Therapy - the RESMAIN Study

Study Treatments

• Experimental arm: resminostat (3 x 200mg oral, 5 days treatment followed by 9 days rest)
• Placebo arm: matching placebo (5 days treatment followed by 9 days rest)

Inclusion criteria

• 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
• ECOG score 0-2

Exclusion criteria

• Patients with progressive disease (PD)
• Baseline corrected QT (QTc) interval > 500 milliseconds

Participating sites

• Cliniques Universitaires UCL Saint Luc