Clinical trial NCT02953301: Resminostat for Maintenance Treatment of Patients With Advanced Stage Mycosis Fungoides (MF) or Sézary Syndrome (SS)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mycosis Fungoides
Sezary Syndrome
Lymphoma, T-Cell, Cutaneous
Keywords: Cutaneous T-Cell Lymphoma (CTLC)
Maintenance
resminostat
4SC
HDAC
Mycosis Fungoides
Sézary Syndrome
Lead sponsor: 4SC AG
Sponsor class: INDUSTRY
First posted: 2016-11-02
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
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
Secondary outcomes:
measure: TTSW (Time to symptom worsening): pruritus
timeFrame: 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:
measure: TTP (Time to progression)
timeFrame: From date of randomization until the date of first documented progression, up to approximately 32 months
measure: TTNT (Time to next treatment)
timeFrame: From date of randomisation to first date that new treatment is received, up to approximately 44 months.
measure: PFS2, PFS3 (Progression-free survival 2, 3)
timeFrame: 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
measure: ORR (Overall response rate)
timeFrame: Percent of patients within each treatment Arm that achieve confirmed CR or PR relative to the number of patients belonging to the analysis population of interest, up to approximately 32 months.
measure: DOR (Duration of response)
timeFrame: From date confirmed CR or PR (whichever is first) until the criteria for PD have been met, up to approximately 32 months.
measure: OS (Overall survival)
timeFrame: From the day of randomisation to death from any cause, up to approximately 44 months.
measure: Incidence of treatment-related AEs and SAEs (Safety and tolerability)
timeFrame: Weekly for 3 cycles, then bi-weekly during treatment phase, up to approximately 9 months
measure: HrQoL (Health related quality of life)
timeFrame: Every 28 days, up to approximately 32 months
measure: Maximum Plasma Concentration [Cmax]
timeFrame: At Cycle 3, Day 1 at 0.75h, 2h and 4 h after intake of trial medication / at Cycle 3, Day 5 to be done pre-dose and at 2h and 7h after intake of trial medication
measure: Area Under the Curve [AUC]
timeFrame: At Cycle 3, Day 1 at 0.75h, 2h and 4 h after intake of trial medication / at Cycle 3, Day 5 to be done pre-dose and at 2h and 7h after intake of trial medication
Locations:
city: Graz
country: Austria
facility: Medizinische Universität Graz
city: Wien
country: Austria
facility: Medizinische Universität Wien
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen
city: Bordeaux
country: France
facility: Centre Hospitalier Universitaire (CHU) de Bordeaux - Hôpital Saint-André
city: Clermont-Ferrand
country: France
facility: CHU Estaing
city: Lyon
country: France
facility: Centre Hospitalier Lyon-Sud
city: Paris
country: France
facility: Chu Paris-Gh St-Louis Lariboisiere F.Widal Hopital
city: Reims
country: France
facility: Hopital Robert Debre - CHU de Reims
city: Berlin
country: Germany
facility: Charité - Universitaetsmedizin Berlin
city: Bochum
country: Germany
facility: Universitaetsklinikum Bochum - St. Josef-Hospital
city: Buxtehude
country: Germany
facility: Elbekliniken Buxtehude
city: Cologne
country: Germany
facility: Uniklinik Köln
city: Dortmund
country: Germany
facility: Klinikum Dortmund
city: Gera
country: Germany
facility: SRH Wald-Klinikum Gera
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen
city: Halle (Saale)
country: Germany
facility: Universitaetsklinikum Halle
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein (UKSH), Campus Kiel
city: Krefeld
country: Germany
facility: HELIOS Klinikum
city: Ludwigshafen am Rhein
country: Germany
facility: Klinikum der Stadt Ludwigshafen am Rhein
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
city: Mannheim
country: Germany
facility: Universitätsklinikum Mannheim
city: Minden
country: Germany
facility: Johannes Wesling Klinikum Minden
city: Tübingen
country: Germany
facility: Universitäts-Hautklinik Tübingen
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Athens
country: Greece
facility: ATTIKON Hospital and Cutaneous Lymphoma Clinic
city: Firenze
country: Italy
facility: Universita Di Firenze
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
city: Roma
country: Italy
facility: Universita Cattolica del Sacro Cuore
city: Rome
country: Italy
facility: IFO San Gallicano
city: Turin
country: Italy
facility: Ospedale Molinette
city: Niigata
country: Japan
facility: Niigata University Medical and Dental Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Sendai
country: Japan
facility: Tohoku University Hospital
city: Shizuoka
country: Japan
facility: Hamamatsu University School of Medicine
city: Tsukuba
country: Japan
facility: University of Tsukuba Hospital
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum (LUMC)
city: Gdansk
country: Poland
facility: Medical University of Gdansk
city: Kraków
country: Poland
facility: SP ZOZ Szpital Uniwersytecki w Krakowie
city: Warsaw
country: Poland
facility: Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie
city: Łódź
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. WAM - CSW
city: Barcelona
country: Spain
facility: Hospital Del Mar
city: Barcelona
country: Spain
facility: Hospital Duran i Reynals
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Tenerife
country: Spain
facility: Hospital Uni. Nuestra Senora de Candelaria
city: Valencia
country: Spain
facility: Hospital General Universitario
city: Lausanne
country: Switzerland
facility: Centre hospitalier universitaire vaudois (CHUV)
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich
city: Birmingham
country: United Kingdom
facility: University Hospital
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
city: London
country: United Kingdom
facility: St John's Institute Of Dermatology - Guy's & St Thomas' Nhs Foundation Trust
city: Manchester
country: United Kingdom
facility: Christie Hospital
Study officials:
affiliation: Johannes Wesling Klinikum, Minden, Germany
name: Rudolf Stadler, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.