Resminostat for Maintenance Treatment of Patients With Ad... | NCT02953301

ID	Type	Description	Link
2016-000807-99	EudraCT Number

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

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
resminostat	Experimental	3 x 200 mg tablets p.o., 5 days treatment followed by 9 days rest (cycles until progress or unacceptable toxicity)	Drug: resminostat
Placebo	Placebo Comparator	3 tablets p.o. matching verum, 5 days treatment followed by 9 days rest (cycles until progress or unacceptable toxicity)	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
resminostat	Drug		resminostat	4SC-201
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PFS (Progression-free survival)	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.	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 Outcomes

Measure	Description	Time Frame
TTSW (Time to symptom worsening): pruritus	To determine if maintenance treatment with resminostat increases time to symptom (pruritus) worsening (TTSW) compared to placebo.	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

Other Outcomes

Measure	Description	Time Frame
TTP (Time to progression)	Compare time to progression (TTP) in patients when treated with resminostat vs placebo	From date of randomization until the date of first documented progression, up to approximately 32 months
TTNT (Time to next treatment)

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Rudolf Stadler, Prof.	Johannes Wesling Klinikum, Minden, Germany	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Medizinische Universität Graz		Graz			Austria
Medizinische Universität Wien

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41651641	Derived	Stadler R, Quaglino P, Woei-A-Jin FJSH, Dummer R, Mitteldorf C, Papadavid E, Ortiz Romero PL, Guenova E, Abe R, Cowan R, Bagot M, Dalle S, Fujimura T, Gambichler T, Morris S, Wehkamp U, Terheyden P, Cozzio A, Dippel E, Alberti-Violetti S, Romejko-Jarosinska J, Wozniacka A, Gonzalez Barca E, Pujol Vallverdu R, Ramelyte E, Bechter O, Suzuki K, Knobler R, Danhauser-Riedl S, Scarisbrick J; RESMAIN Investigators. Resminostat for maintenance treatment in patients with advanced-stage mycosis fungoides or Sezary syndrome: a multicentre, double-blind, randomised, placebo-controlled, phase 2 trial. Lancet Haematol. 2026 Feb;13(2):e98-e109. doi: 10.1016/S2352-3026(25)00322-9.
32632956

IPD Sharing Statement Module

Ancestor Terms

ID	Term
D016399	Lymphoma, T-Cell
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases

ID	Term
D009182	Mycosis Fungoides
D012751	Sezary Syndrome
D016410	Lymphoma, T-Cell, Cutaneous