Status:
NO_LONGER_AVAILABLE
Compassionate Use of Vorinostat for the Treatment of Patients With Advanced Cutaneous T-Cell Lymphoma (0683-042)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Lymphoma, T-Cell, Cutaneous
Eligibility:
All Genders
18+ years
Brief Summary
In an effort to allow patients continued access to vorinostat outside of the base study, patients that are actively receiving study medication will discontinue from this study and receive vorinostat v...
Eligibility Criteria
Inclusion
- Advanced cutaneous T-cell lymphoma on or following two systemic therapies
- Female participants must have a negative serum pregnancy test within 3 days of the first dose of vorinostat
- Female participants must have finished menopause, or are surgically sterilized, or agree to use 2 adequate barrier methods of contraception
- Male participants must agree to use 2 adequate barrier methods of contraception
- To be treated on extension phase of study participant must have been treated on the base study for Protocol 042
Exclusion
- Currently receiving any potential histone deacetylase (HDAC) inhibitor (e.g. valproic acid)
- Currently receiving any other systemic therapy for CTCL. Corticosteroids that are similar in strength to 20 mg of prednisone daily are permitted
- Pregnant or lactating
- Known allergy to any component of the study drug
- Eligible for any other study of vorinostat in CTCL patients
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00419367
Last Update
September 22 2022
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