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

  • STATUS
    Recruiting
  • End date
    Dec 1, 2022
  • participants needed
    190
  • sponsor
    4SC AG
Updated on 15 September 2021
systemic therapy
interferon
maintenance treatment
chemotherapy regimen
sezary syndrome
renal function test
mycosis
bexarotene
resminostat

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 Szary Syndrome that have recently achieved disease control with previous systemic therapy.

Details
Condition Mycosis Fungoides, Sezary Syndrome, cutaneous T-cell lymphoma, Lymphoproliferative Disorder, Sézary Syndrome, Sézary Syndrome, Sézary Syndrome, Sézary Syndrome, Sézary Syndrome, Sézary Syndrome, Sézary Syndrome, Sézary Syndrome, Sézary Syndrome, Sézary Syndrome, Sézary Syndrome, Sézary Syndrome, Sézary Syndrome, Sézary Syndrome, Lymphoproliferative disorders, Sézary Syndrome, Sézary Syndrome, Sézary Syndrome, Sézary Syndrome, Sézary Syndrome, Sézary Syndrome, Sézary Syndrome, Sézary Syndrome, Sézary Syndrome, Sézary Syndrome, Sézary Syndrome, Sézary Syndrome, Sézary Syndrome, Sézary Syndrome, Sézary Syndrome, Sézary Syndrome, Sézary Syndrome, Sézary Syndrome, Sézary Syndrome, Sézary Syndrome, Sézary Syndrome, Sézary Syndrome, Sézary Syndrome, Sézary Syndrome, Sézary Syndrome, Sézary Syndrome, Sézary Syndrome, Sézary Syndrome, Sézary Syndrome, Sézary Syndrome, Sézary Syndrome
Treatment Placebo, resminostat
Clinical Study IdentifierNCT02953301
Sponsor4SC AG
Last Modified on15 September 2021

Eligibility

Yes No Not Sure

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 -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

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
Clear my responses

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