Clinical trial · Interventional
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
NCT00699296CI-TRIAL-00008540terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cutaneous T-Cell Lymphoma | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| Leukemia-Lymphoma, Adult T-Cell | Adult T-Cell Leukemia/Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Panobinostat (LBH589) | Drug | Panobinostat | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: Panobinostat (LBH589)
Primary outcomes (1)
- measure
- 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
- timeFrame
- Every Cycle
Secondary outcomes (1)
- measure
- 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
- timeFrame
- 1 cycle
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.