Back to resultsResminostat for Maintenance Treatment of Patients With Advanced Stage Mycosis Fungoides (MF) or Sézary Syndrome (SS) (RESMAIN)
Primary Purpose
Mycosis Fungoides, Sezary Syndrome, Lymphoma, T-Cell, Cutaneous
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
resminostat
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Mycosis Fungoides focused on measuring Cutaneous T-Cell Lymphoma (CTLC), Maintenance, resminostat, 4SC, HDAC, Mycosis Fungoides, Sézary Syndrome
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
Sites / Locations
- Medizinische Universität Graz
- Medizinische Universität Wien
- Cliniques Universitaires Saint-Luc
- Universitaire Ziekenhuizen
- Centre Hospitalier Universitaire (CHU) de Bordeaux - Hôpital Saint-André
- CHU Estaing
- Centre Hospitalier Lyon-Sud
- Chu Paris-Gh St-Louis Lariboisiere F.Widal Hopital
- Hopital Robert Debre - CHU de Reims
- Charité - Universitaetsmedizin Berlin
- Universitaetsklinikum Bochum - St. Josef-Hospital
- Elbekliniken Buxtehude
- Uniklinik Köln
- Klinikum Dortmund
- SRH Wald-Klinikum Gera
- Universitätsmedizin Göttingen
- Universitaetsklinikum Halle
- Universitaetsklinikum Hamburg-Eppendorf
- Universitaetsklinikum Schleswig-Holstein (UKSH), Campus Kiel
- HELIOS Klinikum
- Klinikum der Stadt Ludwigshafen am Rhein
- Universitätsklinikum Schleswig-Holstein
- Universitätsklinikum Mannheim
- Johannes Wesling Klinikum Minden
- Universitäts-Hautklinik Tübingen
- Universitätsklinikum Ulm
- ATTIKON Hospital and Cutaneous Lymphoma Clinic
- Universita Di Firenze
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
- Universita Cattolica del Sacro Cuore
- IFO San Gallicano
- Ospedale Molinette
- Niigata University Medical and Dental Hospital
- Okayama University Hospital
- Tohoku University Hospital
- Hamamatsu University School of Medicine
- University of Tsukuba Hospital
- Leids Universitair Medisch Centrum (LUMC)
- Medical University of Gdansk
- SP ZOZ Szpital Uniwersytecki w Krakowie
- Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie
- Uniwersytecki Szpital Kliniczny im. WAM - CSW
- Hospital Del Mar
- Hospital Duran i Reynals
- Hospital Universitario 12 de Octubre
- Hospital Uni. Nuestra Senora de Candelaria
- Hospital General Universitario
- Centre hospitalier universitaire vaudois (CHUV)
- Kantonsspital St. Gallen
- Universitätsspital Zürich
- University Hospital
- Beatson West of Scotland Cancer Centre
- St John's Institute Of Dermatology - Guy's & St Thomas' Nhs Foundation Trust
- Christie Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
resminostat
Placebo
Arm Description
3 x 200 mg tablets p.o., 5 days treatment followed by 9 days rest (cycles until progress or unacceptable toxicity)
3 tablets p.o. matching verum, 5 days treatment followed by 9 days rest (cycles until progress or unacceptable toxicity)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
TTSW (Time to symptom worsening): pruritus
To determine if maintenance treatment with resminostat increases time to symptom (pruritus) worsening (TTSW) compared to placebo.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02953301
Brief Title
Resminostat for Maintenance Treatment of Patients With Advanced Stage Mycosis Fungoides (MF) or Sézary Syndrome (SS)
Acronym
RESMAIN
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 2016 (Actual)
Primary Completion Date
March 2023 (Actual)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
4SC AG
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mycosis Fungoides, Sezary Syndrome, Lymphoma, T-Cell, Cutaneous
Keywords
Cutaneous T-Cell Lymphoma (CTLC), Maintenance, resminostat, 4SC, HDAC, Mycosis Fungoides, Sézary Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
201 (Actual)
8. Arms, Groups, and Interventions
Arm Title
resminostat
Arm Type
Experimental
Arm Description
3 x 200 mg tablets p.o., 5 days treatment followed by 9 days rest (cycles until progress or unacceptable toxicity)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
3 tablets p.o. matching verum, 5 days treatment followed by 9 days rest (cycles until progress or unacceptable toxicity)
Intervention Type
Drug
Intervention Name(s)
resminostat
Other Intervention Name(s)
4SC-201
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
PFS (Progression-free survival)
Description
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.
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
Secondary Outcome Measure Information:
Title
TTSW (Time to symptom worsening): pruritus
Description
To determine if maintenance treatment with resminostat increases time to symptom (pruritus) worsening (TTSW) compared to placebo.
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
Other Pre-specified Outcome Measures:
Title
TTP (Time to progression)
Description
Compare time to progression (TTP) in patients when treated with resminostat vs placebo
Time Frame
From date of randomization until the date of first documented progression, up to approximately 32 months
Title
TTNT (Time to next treatment)
Description
Compare time to next treatment (TTNT) in patients when treated with resminostat vs placebo
Time Frame
From date of randomisation to first date that new treatment is received, up to approximately 44 months.
Title
PFS2, PFS3 (Progression-free survival 2, 3)
Description
Assess the effect of maintenance treatment with resminostat by means of PFS of subsequent treatments (PFS2, PFS3)
Time Frame
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
Title
ORR (Overall response rate)
Description
Compare overall response rate (ORR, including CR, PR) in patients when treated with resminostat vs placebo
Time Frame
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.
Title
DOR (Duration of response)
Description
Compare duration of response (DOR) in patients when treated with resminostat vs placebo
Time Frame
From date confirmed CR or PR (whichever is first) until the criteria for PD have been met, up to approximately 32 months.
Title
OS (Overall survival)
Description
Compare overall survival (OS) in patients when treated with resminostat vs placebo
Time Frame
From the day of randomisation to death from any cause, up to approximately 44 months.
Title
Incidence of treatment-related AEs and SAEs (Safety and tolerability)
Description
Assess the safety and tolerability of resminostat
Time Frame
Weekly for 3 cycles, then bi-weekly during treatment phase, up to approximately 9 months
Title
HrQoL (Health related quality of life)
Description
Compare changes in health related quality of life (HrQoL) parameters in patients when treated with resminostat vs placebo
Time Frame
Every 28 days, up to approximately 32 months
Title
Maximum Plasma Concentration [Cmax]
Description
Assess the maximum plasma concentration [Cmax] of resminostat and metabolites
Time Frame
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
Title
Area Under the Curve [AUC]
Description
Assess the Area Under the Curve [AUC] of resminostat and metabolites
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rudolf Stadler, Prof.
Organizational Affiliation
Johannes Wesling Klinikum, Minden, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medizinische Universität Graz
City
Graz
Country
Austria
Facility Name
Medizinische Universität Wien
City
Wien
Country
Austria
Facility Name
Cliniques Universitaires Saint-Luc
City
Bruxelles
Country
Belgium
Facility Name
Universitaire Ziekenhuizen
City
Leuven
Country
Belgium
Facility Name
Centre Hospitalier Universitaire (CHU) de Bordeaux - Hôpital Saint-André
City
Bordeaux
Country
France
Facility Name
CHU Estaing
City
Clermont-Ferrand
Country
France
Facility Name
Centre Hospitalier Lyon-Sud
City
Lyon
Country
France
Facility Name
Chu Paris-Gh St-Louis Lariboisiere F.Widal Hopital
City
Paris
Country
France
Facility Name
Hopital Robert Debre - CHU de Reims
City
Reims
Country
France
Facility Name
Charité - Universitaetsmedizin Berlin
City
Berlin
Country
Germany
Facility Name
Universitaetsklinikum Bochum - St. Josef-Hospital
City
Bochum
Country
Germany
Facility Name
Elbekliniken Buxtehude
City
Buxtehude
Country
Germany
Facility Name
Uniklinik Köln
City
Cologne
Country
Germany
Facility Name
Klinikum Dortmund
City
Dortmund
Country
Germany
Facility Name
SRH Wald-Klinikum Gera
City
Gera
Country
Germany
Facility Name
Universitätsmedizin Göttingen
City
Göttingen
Country
Germany
Facility Name
Universitaetsklinikum Halle
City
Halle (Saale)
Country
Germany
Facility Name
Universitaetsklinikum Hamburg-Eppendorf
City
Hamburg
Country
Germany
Facility Name
Universitaetsklinikum Schleswig-Holstein (UKSH), Campus Kiel
City
Kiel
Country
Germany
Facility Name
HELIOS Klinikum
City
Krefeld
Country
Germany
Facility Name
Klinikum der Stadt Ludwigshafen am Rhein
City
Ludwigshafen am Rhein
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein
City
Lübeck
Country
Germany
Facility Name
Universitätsklinikum Mannheim
City
Mannheim
Country
Germany
Facility Name
Johannes Wesling Klinikum Minden
City
Minden
Country
Germany
Facility Name
Universitäts-Hautklinik Tübingen
City
Tübingen
Country
Germany
Facility Name
Universitätsklinikum Ulm
City
Ulm
Country
Germany
Facility Name
ATTIKON Hospital and Cutaneous Lymphoma Clinic
City
Athens
Country
Greece
Facility Name
Universita Di Firenze
City
Firenze
Country
Italy
Facility Name
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
City
Milano
Country
Italy
Facility Name
Universita Cattolica del Sacro Cuore
City
Roma
Country
Italy
Facility Name
IFO San Gallicano
City
Rome
Country
Italy
Facility Name
Ospedale Molinette
City
Turin
Country
Italy
Facility Name
Niigata University Medical and Dental Hospital
City
Niigata
Country
Japan
Facility Name
Okayama University Hospital
City
Okayama
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai
Country
Japan
Facility Name
Hamamatsu University School of Medicine
City
Shizuoka
Country
Japan
Facility Name
University of Tsukuba Hospital
City
Tsukuba
Country
Japan
Facility Name
Leids Universitair Medisch Centrum (LUMC)
City
Leiden
Country
Netherlands
Facility Name
Medical University of Gdansk
City
Gdansk
Country
Poland
Facility Name
SP ZOZ Szpital Uniwersytecki w Krakowie
City
Kraków
Country
Poland
Facility Name
Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie
City
Warsaw
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny im. WAM - CSW
City
Łódź
Country
Poland
Facility Name
Hospital Del Mar
City
Barcelona
Country
Spain
Facility Name
Hospital Duran i Reynals
City
Barcelona
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
Country
Spain
Facility Name
Hospital Uni. Nuestra Senora de Candelaria
City
Tenerife
Country
Spain
Facility Name
Hospital General Universitario
City
Valencia
Country
Spain
Facility Name
Centre hospitalier universitaire vaudois (CHUV)
City
Lausanne
Country
Switzerland
Facility Name
Kantonsspital St. Gallen
City
St. Gallen
Country
Switzerland
Facility Name
Universitätsspital Zürich
City
Zürich
Country
Switzerland
Facility Name
University Hospital
City
Birmingham
Country
United Kingdom
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
Country
United Kingdom
Facility Name
St John's Institute Of Dermatology - Guy's & St Thomas' Nhs Foundation Trust
City
London
Country
United Kingdom
Facility Name
Christie Hospital
City
Manchester
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32632956
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.
Results Reference
derived
Learn more about this trial
Resminostat for Maintenance Treatment of Patients With Advanced Stage Mycosis Fungoides (MF) or Sézary Syndrome (SS)
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