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

4SC

Status and phase: Completed; Phase 2

Conditions: Mycosis Fungoides; Sezary Syndrome; Lymphoma, T-Cell, Cutaneous

Treatments: Drug: resminostat; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02953301

2016-000807-99 (EudraCT Number)

4SC-201-6-2015

Details and patient eligibility

About

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.

Enrollment: 201 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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201 participants in 2 patient groups, including a placebo group

resminostat

Experimental group

Description:

3 x 200 mg tablets p.o., 5 days treatment followed by 9 days rest (cycles until progress or unacceptable toxicity)

Treatment:

Drug: resminostat

Placebo

Placebo Comparator group

Description:

3 tablets p.o. matching verum, 5 days treatment followed by 9 days rest (cycles until progress or unacceptable toxicity)

Treatment:

Drug: Placebo