Study of Oral LBH589 in Patients With Cutaneous T-cell Lymphoma and Adult T-cell Leukemia/Lymphoma
Phase 2
Terminated
- Conditions
- Cutaneous T-Cell LymphomaLeukemia-Lymphoma, Adult T-Cell
- Interventions
- Registration Number
- NCT00699296
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 4
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Panobinostat (LBH589) -
- Primary Outcome Measures
Name Time Method 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 Every Cycle
- Secondary Outcome Measures
Name Time Method 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 1 cycle
Trial Locations
- Locations (7)
Okayama University Hospital
🇯🇵Okayama, Japan
University Hospital of Occupational and Environmental Health
🇯🇵Fukuoka, Japan
Imamura Bun-in Hospital
🇯🇵Kagoshima, Japan
University of Miyazaki Hospital
🇯🇵Miyazaki, Japan
Kumamoto University Hospital
🇯🇵Kumamoto, Japan
Nagasaki University Hospital of Medicine and Dentistry
🇯🇵Nagasaki, Japan
The University of Tokyo Hospital
🇯🇵Tokyo, Japan