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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Phase IIA Study on Therapy With the NF-κB Inhibiting and Apoptosis Inducing Drug Dimethylfumarate (DMF) in Patients With Cutaneous T Cell Lymphoma (CTCL)

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.


Detailed Summary:
Sponsor: Universitätsmedizin Mannheim

Current Primary Outcome:

  • safety (via occurrence of AE/SAE) of DMF treatment in CTCL [ Time Frame: 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 [ Time Frame: 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]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • changes in dermatologic life quality index [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: every 2 weeks until 24 weeks of treatment are finished ]


Original Secondary Outcome: Same as current

Information By: Universitätsmedizin Mannheim

Dates:
Date Received: September 6, 2015
Date Started: September 2015
Date Completion: September 2017
Last Updated: May 10, 2016
Last Verified: May 2016