Study on Therapy With Dimethylfumarate (DMF) in Patients With Cutaneous T Cell Lymphoma (CTCL)

Inclusion criteria

• Histopathologically confirmed Mycosis fungoides or Sézary syndrome (CTCL stage ≥ Ib according to EORTC-ISCL consensus classification) at study entry with progressive, persistant or recurrent disease
• Pretreatment with at least one topical or systemic CTCL therapy or UV therapy, if the prior therapy is not possible anymore or if there is new contraindication or unsatisfactory response
• 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.

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