DMF-CTCL: Study on Therapy With Dimethylfumarate (DMF) in Patients With Cutaneous T Cell Lymphoma (CTCL)
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: treatment arm patients are treated with dimethylfumarate over 24 weeks. Dosage will be escalated weekly from 30 mg/d to 720 mg/d over 9 weeks. The dose escalation scheme is the same as approved for psoriasis treatment in Germany |
Drug: dimethylfumarate
dose escalation from 30 mg/d to 720 mg/d over 9 weeks following a preset design in psoriasis treatment in Germany, oral medication in tablet form. Treatment will last 24 weeks or until unacceptable side effects occur
|
Outcome Measures
Primary Outcome Measures
- safety (via occurrence of AE/SAE) of DMF treatment in CTCL [every 2 weeks until 24 weeks of treatment are finished]
Number of patients with Treatment-related Adverse Events as assessed by CTCAE v4.0
- efficacy (via improvement of Skin involvement measured by the standardized modified severity weighted assessment tool (mSWAT))of DMF treatment in CTCL [every 2 weeks until 24 weeks of treatment are finished]
Changes in the mSWAT scores range from 0 [no patches, Plaques or tumors on the Skin ] to 400 [complete Body covered by Tumors]
Secondary Outcome Measures
- changes in dermatologic life quality index [every 2 weeks until 24 weeks of treatment are finished]
Scores range from 0 [no restriction of life Quality] to 30 [maximal restriction of life Quality]
- changes in pruritus intensity measured by a visual analog scale [every 2 weeks until 24 weeks of treatment are finished]
Scores range from 0 [no Pruritus] to 10 [worst possible Pruritus]
- changes in blood involvement measured by Sezary cell count (if applicable, only in stage IV patients) [every 2 weeks until 24 weeks of treatment are finished]
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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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
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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)
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Life expectancy > 3 months
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Age ≥ 18 years
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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)
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Negative Pregnancy test from urine, agreement for efficient contraception in male and female patients unless infertility is documented (DMF is not approved during pregnancy)
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Ability to understand character and individual consequences of the clinical trial and to provide written informed consent to participate in the study
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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:
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Another active malignant disease
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Topical chemotherapy, superficial radiotherapy, photopheresis or systemic CTCL treatment within 28 days before study therapy initiation
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Severe systemic disease or infection at study therapy initiation
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Prior treatment with DMF or simultaneous topical DMF treatment
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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)
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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
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Participation in other clinical studies within 14 days before study therapy initiation
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Pregnant or lactating patients
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Medical Center | Mannheim | Germany | 68167 |
Sponsors and Collaborators
- Universitätsmedizin Mannheim
- Klinikum Minden
- Klinikum Krefeld
- Wuerzburg University Hospital
- KKS Netzwerk
- Klinikum Ludwigshafen
- Universitätsklinikum Kiel
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EudraCT-Number: 2014-000924-11