Ignite Creation Date:
2024-05-06 @ 7:30 AM
Last Modification Date:
2024-10-26 @ 11:49 AM
Study NCT ID:
NCT02546440
Status:
COMPLETED
Last Update Posted:
2023-03-31
First Post:
2015-09-06
Brief Title:
Study on Therapy With Dimethylfumarate DMF in Patients With Cutaneous T Cell Lymphoma CTCL
Sponsor:
Universitätsmedizin Mannheim
Organization:
Universitätsmedizin Mannheim
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DMF-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 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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None