Resminostat for Maintenance Treatment of Patients With Advanced Stage Mycosis Fungoides (MF) or Sézary Syndrome (SS)
RESMAIN
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
2 other identifiers
interventional
201
12 countries
54
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2016
Longer than P75 for phase_2
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2016
CompletedStudy Start
First participant enrolled
November 1, 2016
CompletedFirst Posted
Study publicly available on registry
November 2, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2024
CompletedAugust 30, 2024
August 1, 2024
6.3 years
October 26, 2016
August 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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
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
Other Outcomes (10)
TTP (Time to progression)
From date of randomization until the date of first documented progression, up to approximately 32 months
TTNT (Time to next treatment)
From date of randomisation to first date that new treatment is received, up to approximately 44 months.
PFS2, PFS3 (Progression-free survival 2, 3)
From date of start of subsequent treatment to date of progression or death due to any cause in the absence of documented PD whilst receiving second and third line therapy, respectively, up to approximately 44 months
- +7 more other outcomes
Study Arms (2)
resminostat
EXPERIMENTAL3 x 200 mg tablets p.o., 5 days treatment followed by 9 days rest (cycles until progress or unacceptable toxicity)
Placebo
PLACEBO COMPARATOR3 tablets p.o. matching verum, 5 days treatment followed by 9 days rest (cycles until progress or unacceptable toxicity)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- 4SC AGlead
Study Sites (54)
Medizinische Universität Graz
Graz, Austria
Medizinische Universität Wien
Vienna, Austria
Cliniques Universitaires Saint-Luc
Brussels, Belgium
Universitaire Ziekenhuizen
Leuven, Belgium
Centre Hospitalier Universitaire (CHU) de Bordeaux - Hôpital Saint-André
Bordeaux, France
CHU Estaing
Clermont-Ferrand, France
Centre Hospitalier Lyon-Sud
Lyon, France
Chu Paris-Gh St-Louis Lariboisiere F.Widal Hopital
Paris, France
Hopital Robert Debre - CHU de Reims
Reims, France
Charité - Universitaetsmedizin Berlin
Berlin, Germany
Universitaetsklinikum Bochum - St. Josef-Hospital
Bochum, Germany
Elbekliniken Buxtehude
Buxtehude, Germany
Uniklinik Köln
Cologne, Germany
Klinikum Dortmund
Dortmund, Germany
SRH Wald-Klinikum Gera
Gera, Germany
Universitätsmedizin Göttingen
Göttingen, Germany
Universitaetsklinikum Halle
Halle, Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, Germany
Universitaetsklinikum Schleswig-Holstein (UKSH), Campus Kiel
Kiel, Germany
HELIOS Klinikum
Krefeld, Germany
Klinikum der Stadt Ludwigshafen am Rhein
Ludwigshafen am Rhein, Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, Germany
Universitätsklinikum Mannheim
Mannheim, Germany
Johannes Wesling Klinikum Minden
Minden, Germany
Universitäts-Hautklinik Tübingen
Tübingen, Germany
Universitätsklinikum Ulm
Ulm, Germany
ATTIKON Hospital and Cutaneous Lymphoma Clinic
Athens, Greece
Universita Di Firenze
Florence, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy
Universita Cattolica del Sacro Cuore
Roma, Italy
IFO San Gallicano
Rome, Italy
Ospedale Molinette
Turin, Italy
Niigata University Medical and Dental Hospital
Niigata, Japan
Okayama University Hospital
Okayama, Japan
Tohoku University Hospital
Sendai, Japan
Hamamatsu University School of Medicine
Shizuoka, Japan
University of Tsukuba Hospital
Tsukuba, Japan
Leids Universitair Medisch Centrum (LUMC)
Leiden, Netherlands
Medical University of Gdansk
Gdansk, Poland
SP ZOZ Szpital Uniwersytecki w Krakowie
Krakow, Poland
Uniwersytecki Szpital Kliniczny im. WAM - CSW
Lodz, Poland
Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie
Warsaw, Poland
Hospital Del Mar
Barcelona, Spain
Hospital Duran i Reynals
Barcelona, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Uni. Nuestra Senora de Candelaria
Santa Cruz de Tenerife, Spain
Hospital General Universitario
Valencia, Spain
Centre hospitalier universitaire vaudois (CHUV)
Lausanne, Switzerland
Kantonsspital St. Gallen
Sankt Gallen, Switzerland
Universitätsspital Zürich
Zurich, Switzerland
University Hospital
Birmingham, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
St John's Institute Of Dermatology - Guy's & St Thomas' Nhs Foundation Trust
London, United Kingdom
Christie Hospital
Manchester, United Kingdom
Related Publications (1)
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.
PMID: 32632956DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rudolf Stadler, Prof.
Johannes Wesling Klinikum, Minden, Germany
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2016
First Posted
November 2, 2016
Study Start
November 1, 2016
Primary Completion
March 1, 2023
Study Completion
August 1, 2024
Last Updated
August 30, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share