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

Phase 2

Completed

• Conditions: Cutaneous T Cell Lymphoma
• Interventions: Drug: Dimethyl fumarate

• Registration Number: NCT02546440
• Lead Sponsor: Universitätsmedizin Mannheim

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-06
• Study First Submitted QC: 2015-09-09
• Study First Posted: 2015-09-10
• Primary Completion: 2021-09
• Study Completion: 2022-09
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-28
• Last Update Posted: 2023-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
treatment arm	Dimethyl fumarate	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

University Medical Center; 🇩🇪 Mannheim, Germany