Phase 2
N=139
Study of Oral LBH589 in Adult Patients With Refractory Cutaneous T-Cell Lymphoma
Cutaneous T-Cell Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00425555 ↗Enrolled (actual)
139
Serious AEs
40.3%
Results posted
Aug 2021
Primary outcome: Primary: Overall Response Rate of Participants Using the Modified Severity-Weighted Assessment Tool (mSWAT) — 16.7; 20.3; 18.5 percentage
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Panobinostat (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate of Participants Using the Modified Severity-Weighted Assessment Tool (mSWAT) |
16.7; 20.3; 18.5 | — |
| SECONDARY The Overall Response Rate Using mSWAT Skin Score |
12; 14; 26; 15; 18; 33 | — |
| SECONDARY Time to Response for Responders |
69.5; 85.5; 82.0 | — |
| SECONDARY Duration of Response (DOS) |
170.0; NA; 280.0 | — |
| SECONDARY Progression-free Survival (PFS) |
127.0; 113.0; 114.0 | — |
| SECONDARY Skindex-29 Measurements of Average Sub-scores for Emotions From Baseline up to Cycle 12 |
52.2; 50.6; 48.6; 46.6; 45.9; 44.1 | — |
| SECONDARY Skindex-29 Measurements of Average Sub-scores for Functioning From Baseline up to Cycle 12 |
46.7; 44.7; 43.5; 43.3; 42.6; 39.2 | — |
| SECONDARY Skindex-29 Measurements of Average Sub-scores for Physical Symptoms From Baseline up to Cycle 12 |
60.1; 55.3; 51.4; 47.7; 51.1; 42.9 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of Panobinostat |
11.379; 13.490 | — |
| SECONDARY Time to Peak Concentration (Tmax) of Panobinostat |
1.5; 1.5 | — |
| SECONDARY Area Under the Plasma Concentration AUC0-24, AUC0-48 and AUC 0-infinity of Panobinostat |
110.138; 134.033; 132.019; 159.750; 134.828; 162.673 | — |
| SECONDARY Time of Clast (Tlast) of Panobinostat |
47.9; NA | — |
| SECONDARY Last Observed Plasma Concentration (Clast) of Panobinostat |
0.632; 1.524 | — |
Summary
This study will evaluate the safety and efficacy of LBH489B in adult patients with refractory Cutaneous T-Cell Lymphoma.
Eligibility Criteria
Inclusion criteria
- Written informed consent obtained prior to any screening procedures
- Age ≥ 18 years old
- Patients with biopsy-confirmed stages IB-IVA mycosis fungoides or Sézary syndrome. Patients with SS who have bone marrow involvement are also eligible.
- Patients must have received at least two prior treatment regimens at least one of which was a systemic therapy regimen. Systemic regimens include oral bexarotene, PUVA, photophoresis, oral corticosteroids, total skin electron bean therapy, chemotherapy such as methotrexate, and interferon. Topical steroids alone are not considered as a treatment regimen.
- Patients must have had disease progression on or following their most recent treatment regimen or an inadequate response to their most recent treatment regimen.
- Patients will be accrued to one of two groups: Patients previously treated with oral bexarotene and patients who have not had prior oral bexarotene treatment.
Exclusion criteria
- Prior treatment with an HDAC inhibitor.
- Patients with visceral disease including CNS involvement (i.e. stage IVB CTCL). Note; Patients with SS who have bone marrow involvement are eligible.
- Impaired cardiac function
- Concomitant use of drugs with a risk of causing torsades de pointes
- Patients who have received chemotherapy or any investigational drug or undergone major surgery CTCAE grade 1
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral LBH589
- Other concurrent severe and/or uncontrolled medical conditions
- Patients who would need to receive valproic acid for any reason during the study or ≤ 5 days prior to starting study drug.
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT00425555). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.