Cutaneous T-cell lymphoma, Mycosis fungoides, Sezary'
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1)Histopathologically proven CTCL patients 2)Clinical stage is 1B or higher 3)Patients who don't respond to ultraviolet therapy 4)Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1 5)Adequate hematologic, hepatic, renal, and cardiac function a)Absolute neutrophil count 1,500/mm3 b)Platelet >=100,000/mm3 c)Hemoglobin >=10.0g/dL d)AST and ALT <=100IU/L e)Creatinine <=1.5mg/dL 6)Patients who have given informed consent
Exclusion criteria
Exclusion criteria: 1)Patients who have treated with vorinostat 2)During treatment with systemic steroid 3)During treatment with retinoids 4)Carrier of HBV, HCV, HIV and so on 5)Patients who have severe comorbidity 6)During treatment with anti-cancer agents 7)Female who are pregnant or nursing, male hope to impregnate 8)Patients who have past history of severe allergy for vorinostat 9)Patients who are judged inappropriate to be enrolled in this study by the doctor in charge.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Response rate Alleviation of itch | — |
Countries
Japan
Contacts
Keio University, School of Medicine Depertment of Dermatology