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| Name | Class |
|---|---|
| Klinikum Minden | UNKNOWN |
| Klinikum Krefeld | UNKNOWN |
| Wuerzburg University Hospital | OTHER |
| KKS Netzwerk |
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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 are dermatologic life quality index, itching and pain measured by a NRS and the blood involvement if applicable.
Primary: safety and efficacy of DMF treatment in CTCL Secondary: Dermatologic Life Quality index, NRS for itching and pain, blood involvement if appl.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment arm | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dimethyl fumarate | Drug | dose escalation from 30 mg/d to maximally 720 mg/d over 9 weeks, then continuing with the highest tolerated dose following a preset design in psoriasis treatment in Germany, oral medication in tablet form. Treatment will last 24 weeks or until either progression or unacceptable side effects occur |
| Measure | Description | Time Frame |
|---|---|---|
| safety (via occurrence of AE/SAE) of DMF treatment in CTCL | Number of patients with Treatment-related Adverse Events as assessed by CTCAE v4.0 | every 2 weeks until 24 weeks of treatment are finished |
| efficacy (via improvement of Skin involvement measured by the standardized modified severity weighted assessment tool (mSWAT))of DMF treatment in CTCL | Changes in the mSWAT scores range from 0 [no patches, Plaques or tumors on the Skin ] to 400 [complete Body covered by Tumors] | every 2 weeks until 24 weeks of treatment are finished |
| Measure | Description | Time Frame |
|---|---|---|
| changes in dermatologic life quality index | Scores range from 0 [no restriction of life Quality] to 30 [maximal restriction of life Quality] | every 2 weeks until 24 weeks of treatment are finished |
| changes in pruritus intensity measured by a visual analog scale |
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Inclusion criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center | Mannheim | 68167 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37217183 | Derived | Nicolay JP, Melchers S, Albrecht JD, Assaf C, Dippel E, Stadler R, Wehkamp U, Wobser M, Zhao J, Burghaus I, Schneider S, Gulow K, Goerdt S, Schurch CM, Utikal JS, Krammer PH. Dimethyl fumarate treatment in relapsed and refractory cutaneous T-cell lymphoma: a multicenter phase 2 study. Blood. 2023 Aug 31;142(9):794-805. doi: 10.1182/blood.2022018669. |
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| ID | Term |
|---|---|
| D016410 | Lymphoma, T-Cell, Cutaneous |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000069462 | Dimethyl Fumarate |
| ID | Term |
|---|---|
| D005650 | Fumarates |
| D003998 | Dicarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| NETWORK |
| Klinikum Ludwigshafen | OTHER |
| University of Kiel | OTHER |
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|
Scores range from 0 [no Pruritus] to 10 [worst possible Pruritus] |
| every 2 weeks until 24 weeks of treatment are finished |
| 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 |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009930 |
| Organic Chemicals |