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

  • STATUS
    Recruiting
  • participants needed
    25
  • sponsor
    Universitätsmedizin Mannheim
Updated on 8 November 2020
metastases
cancer
lymphoma
psoriasis
karnofsky performance status
antineoplastic agents
sezary syndrome
mycosis
bexarotene
puva

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.

Details
Treatment dimethylfumarate
Clinical Study IdentifierNCT02546440
SponsorUniversitätsmedizin Mannheim
Last Modified on8 November 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have cutaneous T-cell lymphoma?
Histopathologically confirmed Mycosis fungoides or Szary 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
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