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
Indication/ConditionCutaneous T-Cell Lymphoma Leukemia-Lymphoma, Adult T-Cell
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.
20mg/day p.o. on three times-a- 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