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

Phase 2

Active, not recruiting

• Conditions: Sezary Syndrome; Lymphoma, T-Cell, Cutaneous; Mycosis Fungoides
• Interventions: Drug: Placebo; Drug: resminostat

• Registration Number: NCT02953301
• Lead Sponsor: 4SC AG

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-26
• Study First Submitted QC: 2016-10-31
• Study Start: 2016-11
• Study First Posted: 2016-11-02
• Primary Completion: 2023-03
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-04
• Last Update Posted: 2023-09-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 201

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	3 tablets p.o. matching verum, 5 days treatment followed by 9 days rest (cycles until progress or unacceptable toxicity)
resminostat	resminostat	3 x 200 mg tablets p.o., 5 days treatment followed by 9 days rest (cycles until progress or unacceptable toxicity)

Primary Outcome Measures

Name	Time	Method
PFS (Progression-free survival)	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.

Secondary Outcome Measures

Name	Time	Method
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	To determine if maintenance treatment with resminostat increases time to symptom (pruritus) worsening (TTSW) compared to placebo.

Trial Locations

Locations (54)

Medizinische Universität Graz; 🇦🇹 Graz, Austria

Medizinische Universität Wien; 🇦🇹 Wien, Austria

Cliniques Universitaires Saint-Luc; 🇧🇪 Bruxelles, 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

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