This study will assess the safety, efficacy and pharmacokinetics of oral LBH589 in Japanese adult patients with refractory cutaneous T-Cell Lymphoma and adult T-cell leukemia/lymphoma. LBH589 is administered orally once a day for three days per week.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
20mg/day p.o. on three times-a- week
University Hospital of Occupational and Environmental Health
Fukuoka, Japan
Imamura Bun-in Hospital
Kagoshima, Japan
Kumamoto University Hospital
Kumamoto, Japan
University of Miyazaki Hospital
Miyazaki, Japan
Overall response (CR/PR) rate by using the modified Severity-Weighted Assessment Tool (mSWAT) to assess skin disease and the combined evaluation of disease in the viscera/lymph nodes, peripheral blood and bone marrow
Time frame: Every Cycle
Response rate using mSWAT Response rate using the Physician's Global Assessment of Clinical Condition (PGA) Responses in index lesions by skin lesion measurements and with photographic supporting documentation Overall response(CR/PR) rate by using PG
Time frame: 1 cycle
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Nagasaki University Hospital of Medicine and Dentistry
Nagasaki, Japan
Okayama University Hospital
Okayama, Japan
The University of Tokyo Hospital
Tokyo, Japan