Cutaneous T cell lymphoma MedDRA version: 20.0 Level: LLT Classification code 10028508 Term: Mycosis fungoides/Sezary syndrome System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Fumaderm initial
Product Name: Fumaderm initial
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: Dimethyl fumarate
CAS Number: 624-49-7
Other descriptive name: DIMETHYL FU
Sponsors
Ruprecht-Karls-University Heidelberg, Medical Faculty Mannheim represented by the chancellor
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Histopathologically confirmed Mycosis fungoides or Sézary syndrome (CTCL stage = Ib according to EORTC-ISCL consensus classification2) at study entry with progressive, persistant or recurrent disease • Pretreatment with topical steroid and/or local PUVA, if the prior therapy is not possible anymore or if there is unsatisfactory response to PUVA or local steroid respectively. Patients with history of first line systemic treatment (interferone or bexarotene) may be included in the study too • Karnofsky index =70 % (according to Karnofsky DA, Burchenal JH. (1949). "The Clinical Evaluation of Chemotherapeutic Agents in Cancer." In: MacLeod CM (Ed), Evaluation of Chemotherapeutic Agents. Columbia Univ Press. Page 196) • Life expectancy > 3 months • Age = 18 years • Adequate organ function: • differential blood count: hemoglobin = 10 g/dl without transfusions, leukocyte count > 3000/µl, lymphocyte count > 700/µl • liver enzymes = 2 x upper limit of normal (ULN) • serum creatinine = 1.5 mg/dl or calculate creatinine clearance = 50 ml/min, • Negative Pregnancy test from blood, agreement for efficient contraception in male and female patients unless infertility is documented (DMF is not approved during pregnancy) • Ability to understand character and individual consequences of the clinical trial and to provide written informed consent to participate in the study • written informed consent must be given according to ICH/GCP, and national/local regulations, before patient registration and prior to any study specific procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: • Another active malignant disease with the following exceptions: • Basal or squamous cell carcinoma of the skin • In situ carcinoma of the cervix or the skin • Topical chemotherapy, superficial radiotherapy, photopheresis or systemic CTCL treatment within 28 days before study therapy initiation • Severe systemic disease or infection at study therapy initiation • Prior treatment with DMF or simultaneous topical DMF treatment • Contraindications for treatment with DMF (known hypersensibility to the drug, severe gastrointestinal disease (like ulcerations), Alcohol abuse, other obligately liver- or nephrotoxic medication, known clinically apparent renal or hepatic insufficiency) • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial • Participation in other clinical studies within 14 days before study therapy initiation • Pregnant or lactating patients
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints will be changes in CTCL severity index, influence of DMF therapy on DLQI, pruritus and pain as well as effects of DMF treatment on blood involvement if applicable. (In patients with stage IV disease the CD4/CD8 ratio and the number of circulating Sézary cells will be monitored.) In addition changes in immunologic and cell death markers in the skin of treated patients will be a secondary endpoint;Timepoint(s) of evaluation of this end point: End of Trial | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the trial is to evaluate safety and efficacy of DMF treatment in patients with CTCL stage =Ib according to EORTC-ISCL consensus classification.;Secondary Objective: Secondary objectives of the study will be: • To determine effects of DMF on the systemic CTCL involvement using the established CTCL severity index/modified severity assessment tool (mSWAT)19,20 • Effects of DMF on life quality of CTCL patients using the well-established dermatologic life quality index (DLQI)21 • Effects of DMF on pruritus and sensations of “burning pain” measured by a visual analog scales (VAS) • DMF effect on immunologic and morphologic blood involvement if applicable using FACS • changes in immunologic and cell death markers in skin samples of the patients using histologic, immune histologic and molecular biological methods ;Primary end point(s): Primary endpoint of the study will be the response rate of patients to DMF treatment. Practically this will be assessed by evaluating the eventual change in modified Severity Weighted Assessment (mSWAT) after an oral DMF treatment period of 24 weeks;Timepoint(s) of evaluation of this end point: after 24 weeks | — |
Countries
Germany
Contacts
Public ContactDermatology
University Medical Center Mannheim
Outcome results
None listed