Resminostat for Maintenance Treatment of Patients With Advanced Stage Mycosis Fungoides (MF) or Sézary Syndrome (SS)
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.
Timeline
- Start
- 2016-11
- Primary completion
- 2023-03
- Completion
- 2024-08
Outcome
Met primary endpoint
paper Median progression-free survival was 8·3 months (95% CI 4·2-15·7) in the resminostat group and 4·2 months (2·8-6·4) in the placebo group PMID 41651641 ↗
paper placebo group (HR 0·62 [95% CI 0·42-0·92]; p=0·015). PMID 41651641 ↗
release “Resminostat met the primary endpoint in the RESMAIN study, demonstrating a statistically significant improvement in progression free survival in CTCL patients” 4sc.com ↗
release “A statistically significant improvement of 97.6% in progression free survival (PFS) compared to placebo (median PFS: 8.3 months versus 4.2 months)” 4sc.com ↗
Publications
- Stadler R, Quaglino P, Woei-A-Jin FJSH, Dummer R, Mitteldorf C, Papadavid E, Ortiz Romero PL, Guenova E, Abe R, Cowan R, Bagot M, Dalle S, Fujimura T, Gambichler T, Morris S, Wehkamp U, Terheyden P, Cozzio A, Dippel E, Alberti-Violetti S, Romejko-Jarosinska J, Wozniacka A, Gonzalez Barca E, Pujol Vallverdu R, Ramelyte E, Bechter O, Suzuki K, Knobler R, Danhauser-Riedl S, Scarisbrick J; RESMAIN Investigators. Resminostat for maintenance treatment in patients with advanced-stage mycosis fungoides or Sezary syndrome: a multicentre, double-blind, randomised, placebo-controlled, phase 2 trial. Lancet Haematol. 2026 Feb;13(2):e98-e109. doi: 10.1016/S2352-3026(25)00322-9.
- Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Resminostat | Small molecule | 600 mg | Oral |