Status:
TERMINATED
Study of Oral LBH589 in Patients With Cutaneous T-cell Lymphoma and Adult T-cell Leukemia/Lymphoma
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Cutaneous T-Cell Lymphoma
Leukemia-Lymphoma, Adult T-Cell
Eligibility:
All Genders
20+ years
Phase:
PHASE2
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 admin...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00699296
Start Date
May 1 2008
Last Update
November 27 2012
Active Locations (7)
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1
University Hospital of Occupational and Environmental Health
Fukuoka, Japan
2
Imamura Bun-in Hospital
Kagoshima, Japan
3
Kumamoto University Hospital
Kumamoto, Japan
4
University of Miyazaki Hospital
Miyazaki, Japan