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

Mycosis Fungoides Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02953301
• Other study ID #: 4SC-201-6-2015
• Secondary ID: 2016-000807-99
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: November 2016
• Est. completion date: June 2024

Study information

• Verified date: September 2023
• Source: 4SC AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 201
• Est. completion date: June 2024
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 a-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

Related Conditions & MeSH terms

• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous
• Mycoses
• Mycosis Fungoides
• Sezary Syndrome
• Syndrome

Intervention

Drug:
• resminostat

• Placebo

Locations

Country	Name	City	State
Austria	Medizinische Universität Graz	Graz
Austria	Medizinische Universität Wien	Wien
Belgium	Cliniques Universitaires Saint-Luc	Bruxelles
Belgium	Universitaire Ziekenhuizen	Leuven
France	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
Germany	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 (Saale)
Germany	Universitaetsklinikum Hamburg-Eppendorf	Hamburg
Germany	Universitaetsklinikum Schleswig-Holstein (UKSH), Campus Kiel	Kiel
Germany	HELIOS Klinikum	Krefeld
Germany	Universitätsklinikum Schleswig-Holstein	Lübeck
Germany	Klinikum der Stadt Ludwigshafen am Rhein	Ludwigshafen am Rhein
Germany	Universitätsklinikum Mannheim	Mannheim
Germany	Johannes Wesling Klinikum Minden	Minden
Germany	Universitäts-Hautklinik Tübingen	Tübingen
Germany	Universitätsklinikum Ulm	Ulm
Greece	ATTIKON Hospital and Cutaneous Lymphoma Clinic	Athens
Italy	Universita Di Firenze	Firenze
Italy	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico	Milano
Italy	Universita Cattolica del Sacro Cuore	Roma
Italy	IFO San Gallicano	Rome
Italy	Ospedale Molinette	Turin
Japan	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
Netherlands	Leids Universitair Medisch Centrum (LUMC)	Leiden
Poland	Medical University of Gdansk	Gdansk
Poland	SP ZOZ Szpital Uniwersytecki w Krakowie	Kraków
Poland	Uniwersytecki Szpital Kliniczny im. WAM - CSW	Lódz
Poland	Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie	Warsaw
Spain	Hospital Del Mar	Barcelona
Spain	Hospital Duran i Reynals	Barcelona
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Uni. Nuestra Senora de Candelaria	Tenerife
Spain	Hospital General Universitario	Valencia
Switzerland	Centre hospitalier universitaire vaudois (CHUV)	Lausanne
Switzerland	Kantonsspital St. Gallen	St. Gallen
Switzerland	Universitätsspital Zürich	Zürich
United Kingdom	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

Sponsors (1)

Lead Sponsor	Collaborator
4SC AG

Countries where clinical trial is conducted

Austria,  Belgium,  France,  Germany,  Greece,  Italy,  Japan,  Netherlands,  Poland,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	TTP (Time to progression)	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
Other	TTNT (Time to next treatment)	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.
Other	PFS2, PFS3 (Progression-free survival 2, 3)	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
Other	ORR (Overall response rate)	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.
Other	DOR (Duration of response)	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.
Other	OS (Overall survival)	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.
Other	Incidence of treatment-related AEs and SAEs (Safety and tolerability)	Assess the safety and tolerability of resminostat	Weekly for 3 cycles, then bi-weekly during treatment phase, up to approximately 9 months
Other	HrQoL (Health related quality of life)	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
Other	Maximum Plasma Concentration [Cmax]	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
Other	Area Under the Curve [AUC]	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
Primary	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	TTSW (Time to symptom worsening): pruritus	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