Study of Oral LBH589 in Patients With Cutaneous T-cell Lymphoma and Adult T-cell Leukemia/Lymphoma

Study Overview
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Brief Summary
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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.

Official Title
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A Phase II Study of Oral LBH589 in Patients With Cutaneous T-cell Lymphoma and Adult T-cell Leukemia/Lymphoma

Conditions
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Cutaneous T-Cell Lymphoma, Leukemia-Lymphoma, Adult T-Cell

Intervention / Treatment
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* Drug: Panobinostat (LBH589)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: CTCL: Biopsy-confirmed MF or SS stages IB-IVA2. Patients who have SS with bone marrow involvement are also eligible. Patients with transformed CTCL are eligible. ATL: Patient with cytologically or histopathologically confirmed lymphoma. Lymphoma should be identified as tumors derived peripheral T-cells by cell surface marker. ATL: Patients with positivity for anti-HTLV-1 antibody Patients must have received at least two systemic therapy regimens. Patients must have had disease progression on or following their most recent treatment regimen. Age ≥ 20 years ECOG Performance Status of ≤ 2 Written informed consent obtained prior to any study specific screening procedures Exclusion criteria: Patients with a history of primary CNS tumors Any history or presence of brain metastases Patients with any peripheral neuropathy ≥ CTCAE grade 2 Patients with unresolved diarrhea > CTCAE grade 1 Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral LBH589 Patients with concurrent severe and/or uncontrolled liver or renal disease Patients using sodium valproate ≤5 days prior to starting study drug Patients with an active bleeding diathesis or on any treatment with therapeutic doses of sodium warfarin or other antivitamin K drugs Patients who have received any investigational drug or chemotherapy or undergone major surgery ≤ 3 weeks prior to starting study drug or who have not recovered from side effects of such therapy Patients who have received biologic therapy, target therapy (e.g. denileukin diftitix ), vaccine, systemic steroids or immunotherapy ≤ 2 weeks prior to starting study treatment or who have not recovered from side effects of such therapy Patients who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Panobinostat (LBH589)<br>* 20mg/day p.o. on three times-a- week<br>* Other names: LBH589;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LBH589, HDAC inhibitor, cutaneous T-ceII lymphoma, adult T-cell leukemia