Clinical Trial: NCT02953301
Resminostat for Maintenance Treatment of Patients With Advanced Stage Mycosis Fungoides (MF) or Sézary Syndrome (SS)
Status:
COMPLETEDPhase:
Phase 2| Lead Sponsor: | 4SC AG |
| Information Provided By: | 4SC AG |
| Last Update Posted: | 2024-08-30 |
Study Overview
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.
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
Conditions
Mycosis Fungoides, Sezary Syndrome, Lymphoma, T-Cell, Cutaneous
Intervention / Treatment
- Drug: resminostat
- Drug: Placebo
Other Study ID Numbers
- 4SC-201-6-2015
- 2016-000807-99
- 2016
Start Date (Actual)
2016-11
Primary Completion Date (Actual)
2023-03
Study Completion Date (Actual)
2024-08
Enrollment (Actual)
201
Study Type
Interventional
Phase
Phase 2
| Lead Sponsor: | 4SC AG |
| Information Provided By: | 4SC AG |
| Last Update Posted: | 2024-08-30 |
Study Overview
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.
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
Conditions
Mycosis Fungoides, Sezary Syndrome, Lymphoma, T-Cell, Cutaneous
Intervention / Treatment
- Drug: resminostat
- Drug: Placebo
Other Study ID Numbers
- 4SC-201-6-2015
- 2016-000807-99
- 2016
Start Date (Actual)
2016-11
Primary Completion Date (Actual)
2023-03
Study Completion Date (Actual)
2024-08
Enrollment (Actual)
201
Study Type
Interventional
Phase
Phase 2