Mycosis FungoidesPhase 2RESMAINNCT02953301
Resminostat for Maintenance Treatment of Patients With Advanced Stage Mycosis Fungoides (MF) or Sézary Syndrome (SS)
A Phase 2 study testing resminostat in people with Mycosis Fungoides and Sezary Syndrome, run by 4SC AG at 54 sites in 12 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mycosis Fungoides, Sezary Syndrome, Lymphoma, T-Cell, Cutaneous
- What is being tested?
- resminostat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 201 participants
- Where
- 54 sitesin 12 countries
- Study dates
- Nov 2016to Aug 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
54 sites in 12 countries.
54 sites in 12 countries
Germany17 sites
Charité - Universitaetsmedizin Berlin
Berlin
Universitaetsklinikum Bochum - St. Josef-Hospital
Bochum
Elbekliniken Buxtehude
Buxtehude
Uniklinik Köln
Cologne
Klinikum Dortmund
Dortmund
SRH Wald-Klinikum Gera
Gera
Universitätsmedizin Göttingen
Göttingen
Universitaetsklinikum Halle
Halle
Universitaetsklinikum Hamburg-Eppendorf
Hamburg
Universitaetsklinikum Schleswig-Holstein (UKSH), Campus Kiel
Kiel
HELIOS Klinikum
Krefeld
Universitätsklinikum Schleswig-Holstein
Lübeck
Klinikum der Stadt Ludwigshafen am Rhein
Ludwigshafen am Rhein
Universitätsklinikum Mannheim
Mannheim
Johannes Wesling Klinikum Minden
Minden
Universitäts-Hautklinik Tübingen
Tübingen
Universitätsklinikum Ulm
Ulm
France5 sites
Centre Hospitalier Universitaire (CHU) de Bordeaux - Hôpital Saint-André
Bordeaux
CHU Estaing
Clermont-Ferrand
Centre Hospitalier Lyon-Sud
Lyon
Chu Paris-Gh St-Louis Lariboisiere F.Widal Hopital
Paris
Hopital Robert Debre - CHU de Reims
Reims
Italy5 sites
Universita Di Firenze
Florence
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan
Universita Cattolica del Sacro Cuore
Roma
IFO San Gallicano
Rome
Ospedale Molinette
Turin
Japan5 sites
Niigata University Medical and Dental Hospital
Niigata
Okayama University Hospital
Okayama
Tohoku University Hospital
Sendai
Hamamatsu University School of Medicine
Shizuoka
University of Tsukuba Hospital
Tsukuba
Spain5 sites
Hospital Del Mar
Barcelona
Hospital Duran i Reynals
Barcelona
Hospital Universitario 12 de Octubre
Madrid
Hospital Uni. Nuestra Senora de Candelaria
Santa Cruz de Tenerife
Hospital General Universitario
Valencia
Poland4 sites
Medical University of Gdansk
Gdansk
SP ZOZ Szpital Uniwersytecki w Krakowie
Krakow
Uniwersytecki Szpital Kliniczny im. WAM - CSW
Lodz
Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie
Warsaw
United Kingdom4 sites
University Hospital
Birmingham
Beatson West of Scotland Cancer Centre
Glasgow
St John's Institute Of Dermatology - Guy's & St Thomas' Nhs Foundation Trust
London
Christie Hospital
Manchester
Switzerland3 sites
Centre hospitalier universitaire vaudois (CHUV)
Lausanne
Kantonsspital St. Gallen
Sankt Gallen
Universitätsspital Zürich
Zurich
Austria2 sites
Medizinische Universität Graz
Graz
Medizinische Universität Wien
Vienna
Belgium2 sites
Cliniques Universitaires Saint-Luc
Brussels
Universitaire Ziekenhuizen
Leuven
About this study
Official title: 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
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.
- Being tested
- resminostat, Placebo
- Keywords
- Cutaneous T-Cell Lymphoma (CTLC), Maintenance, resminostat, 4SC, HDAC, Mycosis Fungoides, Sézary Syndrome
- Medical subject headings
- Mycosis Fungoides, Sezary Syndrome, Lymphoma, T-Cell, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resminostatDrug
Also called 4SC-201
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| resminostat | Experimental | 3 x 200 mg tablets p.o., 5 days treatment followed by 9 days rest (cycles until progress or unacceptable toxicity) Receives: Drug: resminostat |
| Placebo | Placebo comparator | 3 tablets p.o. matching verum, 5 days treatment followed by 9 days rest (cycles until progress or unacceptable toxicity) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS (Progression-free survival)
The primary objective is to determine if maintenance treatment with resminostat increases progression free survival (PFS) compared to placebo in patients with advanced stage (Stage IIB-IVB) MF or SS that have achieved disease control (complete response [CR], partial response [PR] or stable disease [SD]) with previous systemic therapy.
Measured: 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
Secondary outcomes (1)
TTSW (Time to symptom worsening): pruritus
To determine if maintenance treatment with resminostat increases time to symptom (pruritus) worsening (TTSW) compared to placebo.
Measured: From date of randomisation to first date that criteria for symptom (pruritus) worsening have been met, up to approximately 32 months. Symptom worsening is defined as an increase of a minimum of 3 points on the visual analogue itching scale
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionMar 2023
- Study completionAug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mycosis FungoidesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- 4SC AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rudolf Stadler, Prof., Principal investigator, Johannes Wesling Klinikum, Minden, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02953301
- Sponsor's protocol ID
- 4SC-201-6-2015
- Other IDs
- 2016-000807-99, 2016
- Acronym
- RESMAIN
- Status last verified
- Aug 2024
- First submitted
- 26 Oct 2016
- Last updated
- 30 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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.
PubMed 41651641Valipour 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.
PubMed 32632956
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02953301
- Acronym / sponsor ID
- RESMAIN / 4SC-201-6-2015
- Keywords
- Cutaneous T-Cell Lymphoma (CTLC), Maintenance, resminostat, 4SC, HDAC, Mycosis Fungoides, Sézary Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- 4SC AGIndustry (pharma, biotech, devices)
- Study start
- Nov 2016 (actual)
- Primary completion
- Mar 2023 (actual)
- Study completion
- Aug 2024 (actual)
- First posted
- 2 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| resminostat | Experimental | Drug: resminostat3 x 200 mg tablets p.o., 5 days treatment followed by 9 days rest (cycles until progress or unacceptable toxicity) |
| Placebo | Placebo comparator | Drug: Placebo3 tablets p.o. matching verum, 5 days treatment followed by 9 days rest (cycles until progress or unacceptable toxicity) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| resminostatAlso: 4SC-201 | Drug | resminostat |
| Placebo | Drug | Placebo |
Primary outcome
PFS (Progression-free survival)
Time frame: 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
The primary objective is to determine if maintenance treatment with resminostat increases progression free survival (PFS) compared to placebo in patients with advanced stage (Stage IIB-IVB) MF or SS that have achieved disease control (complete response [CR], partial response [PR] or stable disease [SD]) with previous systemic therapy.
1 secondary outcome
TTSW (Time to symptom worsening): pruritus
Time frame: From date of randomisation to first date that criteria for symptom (pruritus) worsening have been met, up to approximately 32 months. Symptom worsening is defined as an increase of a minimum of 3 points on the visual analogue itching scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Derived from this study: PubMed 41651641Stadler 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.
- Derived from this study: PubMed 32632956Valipour 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rudolf Stadler, Prof. principal investigator
Johannes Wesling Klinikum, Minden, Germany
54 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing resminostat in people with Mycosis Fungoides and Sezary Syndrome, run by 4SC AG at 54 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in Germany, France, Italy, Japan, Spain and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (Progression-free survival) (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02953301, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2024.