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

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 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.

Timeline

Start

2015-09

Primary completion

2021-09

Completion

2022-09

Publications

• 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.

Drugs

Indications