Clinical trial · Interventional
Resminostat for Maintenance Treatment of Patients With Advanced Stage Mycosis Fungoides (MF) or Sézary Syndrome (SS)
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
NCT02953301CI-TRIAL-00080350RESMAINcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, T-Cell, Cutaneous | Lymphoma | ONTOLOGY_EXACT | 0.85 |
| Mycosis Fungoides | Mycosis Fungoides | ONTOLOGY_EXACT | 0.98 |
| Sezary Syndrome | Sezary Syndrome | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| resminostat | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- resminostat
- description
- 3 x 200 mg tablets p.o., 5 days treatment followed by 9 days rest (cycles until progress or unacceptable toxicity)
- interventionNames
- Drug: resminostat
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- 3 tablets p.o. matching verum, 5 days treatment followed by 9 days rest (cycles until progress or unacceptable toxicity)
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- PFS (Progression-free survival)
- timeFrame
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Main 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 (including but not limited to α-interferon, bexarotene, total skin electron beam irradiation, chemotherapy) \[the most recent systemic therapy must have been completed as planned or stopped due to unacceptable toxicity 2-12 weeks prior to randomisation\] * Eastern Cooperative Oncology Group (ECOG) status score 0-2 * Adequate haematological, hepatic and renal function Main Exclusion Criteria: * Patients with progressive disease (PD) * Baseline corrected QT (QTc) interval \> 500 milliseconds * Concurrent use of any other specific anti-tumour therapy including psoralen photo chemotherapy (PUVA), chemotherapy, immunotherapy, hormonal therapy, radiation therapy, or experimental medications
References
Publications (2)
- DERIVEDStadler 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. PMID 41651641
- DERIVEDValipour 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. PMID 32632956