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

• Register: ClinicalTrials.gov
• Last refreshed on: 18 September 2023
• Main ID: NCT02953301
• Date of registration: 26/10/2016
• Prospective Registration: Yes
• Primary sponsor: 4SC AG
• Public title: Resminostat for Maintenance Treatment of Patients With Advanced Stage Mycosis Fungoides (MF) or Sézary Syndrome (SS) RESMAIN
• Scientific 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
• Date of first enrolment: November 2016
• Target sample size: 201
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT02953301
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

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

Contacts

• Name: Rudolf Stadler, Prof.
• Affiliation: Johannes Wesling Klinikum, Minden, Germany

Key inclusion & exclusion 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
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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Mycosis Fungoides

Lymphoma, T-Cell, Cutaneous

Sezary Syndrome

Intervention(s)

Drug: resminostat

Drug: Placebo

Primary Outcome(s)

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]

Secondary Outcome(s)

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]

Secondary ID(s)

4SC-201-6-2015

2016-000807-99

Source(s) of Monetary Support

Please refer to primary and secondary sponsors