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

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

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.

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