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

• Status: Unknown status
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The main objective of the trial is to investigate whether oral treatment of patients suffering from cutaneous T cell lymphoma with dimethylfumarate is leading to a significant improvement of modified severity assessment tool (mSWAT) values in the skin after 24 weeks of treatment (primary endpoint). Secondary endpoints will be CTCL severity index, dermatologic life quality index, itching measured by a VAS and the blood involvement if applicable.

Primary: safety and efficacy of DMF treatment in CTCL Secondary: CTCL severity index, Dermatologic Life Quality index, VAS for itching, blood involvement if appl.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universitätsmedizin Mannheim
• Collaborators: KKS Netzwerk; Klinikum Krefeld; Klinikum Ludwigshafen; Klinikum Minden; Universitätsklinikum Kiel; Wuerzburg University Hospital
• Treatments: Dimethyl Fumarate

Criteria

Inclusion Criteria:

• Histopathologically confirmed Mycosis fungoides or Sézary syndrome (CTCL stage ≥ Ib according to EORTC-ISCL consensus classification) at study entry with progressive, persistent or recurrent disease

• Pretreatment with topical steroid and/or local PUVA, if PUVA is not possible anymore or if there is unsatisfactory response to PUVA 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, liver enzymes, serum creatinine, electrolytes and lipids have to show normal values, no history of restriction of cardiac, kidney or liver function)

• Negative Pregnancy test from urine, 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 prior to any study specific procedures.

Exclusion Criteria:

• Another active malignant disease

• 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 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