Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Infections

Rare Diseases

Syndrome

Lymphoma

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Mycoses

Mycosis Fungoides

Lymphoma, T-Cell, Cutaneous

Sezary Syndrome

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Communicable Diseases

Bacterial Infections

Bacterial Infections and Mycoses

Lymphoma, Non-Hodgkin

Lymphosarcoma

Peripheral T-cell Lymphoma

Cutaneous T-cell Lymphoma

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

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

resminostat

Placebo

Rudolf Stadler, Prof.

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.

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

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

Compare time to progression (TTP) in patients when treated with resminostat vs placebo

Compare time to next treatment (TTNT) in patients when treated with resminostat vs placebo

Assess the effect of maintenance treatment with resminostat by means of PFS of subsequent treatments (PFS2, PFS3)

Compare overall response rate (ORR, including CR, PR) in patients when treated with resminostat vs placebo

Compare duration of response (DOR) in patients when treated with resminostat vs placebo

Compare overall survival (OS) in patients when treated with resminostat vs placebo

Assess the safety and tolerability of resminostat

Compare changes in health related quality of life (HrQoL) parameters in patients when treated with resminostat vs placebo

Assess the maximum plasma concentration \[Cmax\] of resminostat and metabolites

Assess the Area Under the Curve \[AUC\] of resminostat and metabolites

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.

To determine if maintenance treatment with resminostat increases time to symptom (pruritus) worsening (TTSW) compared to placebo.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Resminostat for Maintenance Treatment of Patients With Advanced Stage Mycosis Fungoides (MF) or Sézary Syndrome (SS)	NCT02953301	Mycosis Fungoid... Sezary Syndrome Lymphoma, T-Cel...	resminostat Placebo	18 Years -	4SC AG
Resminostat for Maintenance Treatment of Patients With Advanced Stage Mycosis Fungoides (MF) or Sézary Syndrome (SS)	NCT02953301	Mycosis Fungoid... Sezary Syndrome Lymphoma, T-Cel...	resminostat Placebo	18 Years -	4SC AG
Resminostat for Maintenance Treatment of Patients With Advanced Stage Mycosis Fungoides (MF) or Sézary Syndrome (SS)	NCT02953301	Mycosis Fungoid... Sezary Syndrome Lymphoma, T-Cel...	resminostat Placebo	18 Years -	4SC AG

Spots Global Cancer Trial Database for 4sc

Every month we try and update this database with for 4sc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for 4sc

Every month we try and update this database with for 4sc cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for 4sc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.