Cutaneous T-Cell Lymphoma, Leukemia-Lymphoma, Adult T-Cell
Conditions
Keywords
LBH589, HDAC inhibitor, cutaneous T-ceII lymphoma, adult T-cell leukemia
Brief summary
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.
Interventions
20mg/day p.o. on three times-a- week
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Japan
Outcome results
None listed