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

Phase 2

Completed

Conditions: cutaneous lymphoma
Mycosis fungoides / Sézary Syndrome
10025321

Registration Number: NL-OMON55744

Lead Sponsor: 4SC AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 3

Inclusion Criteria

1.Patients with histologically confirmed MF (Stage IIB-IVB) or SS in an ongoing
CR, PR or SD after at least one prior systemic therapy according to local
standards (including but not limited to a-interferon, bexarotene,
extracorporeal photopheresis, chemotherapy) or total skin electron beam
irradiation
- the most recent systemic therapy must have been completed as planned or
stopped due to unacceptable toxicity 2-12 weeks prior to randomisation, i.e.
patients should not be
withdrawn from a treatment from which they derive benefit
2.Male or female >= 18 years
3.Written informed consent obtained prior to any trial specific procedure
4.Eastern Cooperative Oncology Group (ECOG) status score 0-2
5.Adequate haematological, hepatic and renal function, as demonstrated by:
a)haemoglobin >= 9.0 g/dl (International System [SI] of Units: 5.6 mmol/L)
b)absolute neutrophil count >= 1,000/mm3
c)platelets >= 75 × 109/L
d)alanine aminotransferase and aspartate amino-transferase <= 2 times upper
limit of normal
e)total bilirubin <= 2 mg/dL (SI units: 34.2 µmol/L) (unless known Gilbert
syndrome)
f)serum creatinine <= 1.5 mg/dL (SI units: 132 µmol/L)
g)prothrombin time International Normalised Ratio <= 2.3
6.Women of childbearing potential (not post-menopausal for 1 year and not
surgically sterile) and males with partners of childbearing potential must be
sexually abstinent (i.e. refraining
from heterosexual intercourse) or must use a highly effectivecontraception (at
least one of the following: combined (oral, intravaginal or transdermal) or
progestegen-only
(oral, injectable or implantable) hormonal contraceptives, intrauterine
device,intrauterine hormone-releasing system, bilateral tubal occlusion,
vasectomy of the partner from the time of screening to 30 days (female
patients) or 3 months (male patients) after the last dose of trial treatment
7.Adequate recovery from precedent non-haematological toxicities, excluding
alopecia, to <= National Cancer Institute (NCI) Common Terminology Criteria for
Adverse Events (CTCAE) Grade 1
8.Able to comply with all the requirements of the protocol

Exclusion Criteria

1.Patients with PD
2.Known central nervous system involvement
3.History and current cardiovascular complications, including unstable angina
pectoris, uncontrolled hypertension, congestive heart failure (New York Heart
Association [NYHA] Class III or IV) related to primary cardiac disease, a
condition requiring anti arrhythmic therapy, ischemic or severe valvular heart
disease, or a myocardial infarction within 6 months prior to randomisation
4.Baseline corrected QT (QTc) interval > 500 milliseconds [NOTE: QTcF is
relevant]
5.History of additional risk factors for Torsade de Pointes (e.g., heart
failure, hypokalaemia, family history of Long QT Syndrome)
6.Use of concomitant medications that are known to prolong the QT/QTc interval
7.Concurrent use of any other specific anti tumour therapy including psoralen
photo chemotherapy (PUVA), chemotherapy, immunotherapy, hormonal therapy,
radiation therapy, or experimental medications
8.Previous or concurrent cancer that is distinct in primary site or histology
from CTCL, except curatively treated squamous-cell carcinoma of the skin stage
0-1 and curatively treated malignant melanoma stage 0-1A with a low risk of
recurrence/metastasis as per assessment of the investigator, cervical carcinoma
in situ, treated basal cell carcinoma, superficial bladder tumours (Ta, Tis and
T1); any cancer curatively treated > 3 years prior to randomisation will be
allowed
9.Current evidence of any uncontrolled clinically significant internal,
psychiatric or neurologic disease
10.Altered mental status precluding understanding of the informed consent
process and/or completion of the necessary trial procedures
11.Pregnant or breast feeding women
12.History of allergic reactions attributed to compounds of similar chemical or
biological composition to the trial drugs
13.Active alcohol and/or drug abuse
14.Any other acute or chronic condition that, in the investigator*s opinion,
would limit the patient*s ability to complete or participate in this trial

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Efficacy<br /><br>All efficacy assessments will be done according to 2011 ISCL, the United States<br /><br>Cutaneous Lymphoma Consortium (USCLC), and the Cutaneous Lymphoma Task Force of<br /><br>the EORTC consensus statement of clinical endpoints and response criteria in MF<br /><br>and SS.<br /><br><br /><br>Primary Endpoint<br /><br>- PFS<br /><br>PFS is defined as the time from date of randomisation to first date that<br /><br>criteria for PD have been met according to the global response score or death<br /><br>due to any cause in the absence of documented PD.</p><br>

Secondary Outcome Measures

Name	Time	Method

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

Recruitment & Eligibility

Study & Design

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