A Phase II Study of Oral LBH589 in Patients With Cutaneous T-cell Lymphoma and Adult T-cell Leukemia/Lymphoma
- 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
- 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
- Age ≥ 20 years
- ECOG Performance Status of ≤ 2
- Written informed consent obtained prior to any study specific screening procedures
- 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