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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Panobinostat (LBH589) | Drug | 20mg/day p.o. on three times-a- week |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Makoto Sugaya | The University of Tokyo Hospital | Principal Investigator |
| Kenji Iwatsuki | Okayama University | Principal Investigator |
| Yoshiki Tokura | University Hospital of Occupational and Environmental Health | Principal Investigator |
| Kunihiro Tsukasaki | Nagasaki University Hospital of Medicine and Dentistry | Principal Investigator |
| Hironobu In | Kumamoto University Hospital | Principal Investigator |
| Mitsuru Setoyama | University of Miyazaki Hospital | Principal Investigator |
| Atae Utsunomiya | Imamura Bun-in Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Occupational and Environmental Health | Fukuoka | Japan | ||||
| Imamura Bun-in Hospital |
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| ID | Term |
|---|---|
| D016410 | Lymphoma, T-Cell, Cutaneous |
| D015459 | Leukemia-Lymphoma, Adult T-Cell |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000077767 | Panobinostat |
| ID | Term |
|---|---|
| D006877 | Hydroxamic Acids |
| D006898 | Hydroxylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Kagoshima |
| Japan |
| Kumamoto University Hospital | Kumamoto | Japan |
| University of Miyazaki Hospital | Miyazaki | Japan |
| Nagasaki University Hospital of Medicine and Dentistry | Nagasaki | Japan |
| Okayama University Hospital | Okayama | Japan |
| The University of Tokyo Hospital | Tokyo | Japan |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D015458 | Leukemia, T-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D006880 |
| Hydroxy Acids |
| D002264 | Carboxylic Acids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |