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

Novartis

Status and phase

Terminated

Phase 2

Conditions

Leukemia-Lymphoma, Adult T-Cell

Cutaneous T-Cell Lymphoma

Treatments

Drug: Panobinostat (LBH589)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00699296

CLBH589B1201

Details and patient eligibility

About

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.

Enrollment

4 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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