Resminostat for Maintenance Treatment of Patients With Advanced Stage Mycosis Fungoides (MF) or Sézary Syndrome (SS) (RESMAIN)

August 29, 2024 updated by: 4SC AG

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
201

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria
        • Medizinische Universität Graz
      • Wien, Austria
        • Medizinische Universität Wien
  • Belgium
      • Bruxelles, Belgium
        • Cliniques universitaires Saint-Luc
      • Leuven, Belgium
        • Universitaire Ziekenhuizen
  • France
      • Bordeaux, France
        • Centre Hospitalier Universitaire (CHU) de Bordeaux - Hôpital Saint-André
      • Clermont-Ferrand, France
        • CHU Estaing
      • Lyon, France
        • Centre Hospitalier Lyon-Sud
      • Paris, France
        • Chu Paris-Gh St-Louis Lariboisiere F.Widal Hopital
      • Reims, France
        • Hôpital Robert Debré - CHU de Reims
  • Germany
      • Berlin, Germany
        • Charite - Universitaetsmedizin Berlin
      • Bochum, Germany
        • Universitaetsklinikum Bochum - St. Josef-Hospital
      • Buxtehude, Germany
        • Elbekliniken Buxtehude
      • Cologne, Germany
        • Uniklinik Köln
      • Dortmund, Germany
        • Klinikum Dortmund
      • Gera, Germany
        • SRH Wald-Klinikum Gera
      • Göttingen, Germany
        • Universitätsmedizin Göttingen
      • Halle (Saale), Germany
        • Universitaetsklinikum Halle
      • Hamburg, Germany
        • Universitaetsklinikum Hamburg-Eppendorf
      • Kiel, Germany
        • Universitaetsklinikum Schleswig-Holstein (UKSH), Campus Kiel
      • Krefeld, Germany
        • Helios Klinikum
      • Ludwigshafen am Rhein, Germany
        • Klinikum der Stadt Ludwigshafen am Rhein
      • Lübeck, Germany
        • Universitatsklinikum Schleswig-Holstein
      • Mannheim, Germany
        • Universitätsklinikum Mannheim
      • Minden, Germany
        • Johannes Wesling Klinikum Minden
      • Tübingen, Germany
        • Universitäts-Hautklinik Tübingen
      • Ulm, Germany
        • Universitätsklinikum Ulm
  • Greece
      • Athens, Greece
        • ATTIKON Hospital and Cutaneous Lymphoma Clinic
  • Italy
      • Firenze, Italy
        • Universita Di Firenze
      • Milano, Italy
        • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
      • Roma, Italy
        • Universita Cattolica del Sacro Cuore
      • Rome, Italy
        • IFO San Gallicano
      • Turin, Italy
        • Ospedale Molinette
  • Japan
      • Niigata, Japan
        • Niigata University Medical and Dental Hospital
      • Okayama, Japan
        • Okayama University Hospital
      • Sendai, Japan
        • Tohoku University Hospital
      • Shizuoka, Japan
        • Hamamatsu University School of Medicine
      • Tsukuba, Japan
        • University of Tsukuba Hospital
  • Netherlands
      • Leiden, Netherlands
        • Leids Universitair Medisch Centrum (LUMC)
  • Poland
      • Gdansk, Poland
        • Medical University of Gdańsk
      • Kraków, Poland
        • SP ZOZ Szpital Uniwersytecki w Krakowie
      • Warsaw, Poland
        • Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie
      • Łódź, Poland
        • Uniwersytecki Szpital Kliniczny im. WAM - CSW
  • Spain
      • Barcelona, Spain
        • Hospital Del Mar
      • Barcelona, Spain
        • Hospital Duran i Reynals
      • Madrid, Spain
        • Hospital Universitario 12 de Octubre
      • Tenerife, Spain
        • Hospital Uni. Nuestra Senora de Candelaria
      • Valencia, Spain
        • Hospital General Universitario
  • Switzerland
      • Lausanne, Switzerland
        • Centre Hospitalier Universitaire Vaudois (CHUV)
      • St. Gallen, Switzerland
        • Kantonsspital St. Gallen
      • Zürich, Switzerland
        • Universitätsspital Zürich
  • United Kingdom
      • Birmingham, United Kingdom
        • University Hospital
      • Glasgow, United Kingdom
        • Beatson West of Scotland Cancer Centre
      • London, United Kingdom
        • St John's Institute Of Dermatology - Guy's & St Thomas' Nhs Foundation Trust
      • Manchester, United Kingdom
        • Christie Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: resminostat
3 x 200 mg tablets p.o., 5 days treatment followed by 9 days rest (cycles until progress or unacceptable toxicity)
Drug: resminostat
Other Names:
  • 4SC-201
Placebo Comparator: Placebo
3 tablets p.o. matching verum, 5 days treatment followed by 9 days rest (cycles until progress or unacceptable toxicity)
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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 Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
To determine if maintenance treatment with resminostat increases time to symptom (pruritus) worsening (TTSW) compared to placebo.
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 Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
TTP (Time to progression)
Time Frame: From date of randomization until the date of first documented progression, up to approximately 32 months
Compare time to progression (TTP) in patients when treated with resminostat vs placebo
From date of randomization until the date of first documented progression, up to approximately 32 months
TTNT (Time to next treatment)
Time Frame: From date of randomisation to first date that new treatment is received, up to approximately 44 months.
Compare time to next treatment (TTNT) in patients when treated with resminostat vs placebo
From date of randomisation to first date that new treatment is received, up to approximately 44 months.
PFS2, PFS3 (Progression-free survival 2, 3)
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
Assess the effect of maintenance treatment with resminostat by means of PFS of subsequent treatments (PFS2, PFS3)
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
ORR (Overall response rate)
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.
Compare overall response rate (ORR, including CR, PR) in patients when treated with resminostat vs placebo
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.
DOR (Duration of response)
Time Frame: From date confirmed CR or PR (whichever is first) until the criteria for PD have been met, up to approximately 32 months.
Compare duration of response (DOR) in patients when treated with resminostat vs placebo
From date confirmed CR or PR (whichever is first) until the criteria for PD have been met, up to approximately 32 months.
OS (Overall survival)
Time Frame: From the day of randomisation to death from any cause, up to approximately 44 months.
Compare overall survival (OS) in patients when treated with resminostat vs placebo
From the day of randomisation to death from any cause, up to approximately 44 months.
Incidence of treatment-related AEs and SAEs (Safety and tolerability)
Time Frame: Weekly for 3 cycles, then bi-weekly during treatment phase, up to approximately 9 months
Assess the safety and tolerability of resminostat
Weekly for 3 cycles, then bi-weekly during treatment phase, up to approximately 9 months
HrQoL (Health related quality of life)
Time Frame: Every 28 days, up to approximately 32 months
Compare changes in health related quality of life (HrQoL) parameters in patients when treated with resminostat vs placebo
Every 28 days, up to approximately 32 months
Maximum Plasma Concentration [Cmax]
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
Assess the maximum plasma concentration [Cmax] of resminostat and metabolites
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
Area Under the Curve [AUC]
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
Assess the Area Under the Curve [AUC] of resminostat and metabolites
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
4SC AG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rudolf Stadler, Prof., Johannes Wesling Klinikum, Minden, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 26, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 2, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 30, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 4SC-201-6-2015
  • 2016-000807-99 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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