Study of Oral LBH589 in Adult Patients With Refractory Cutaneous T-Cell Lymphoma
Condition: Cutaneous T-Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Lymphoma, T-Cell, Cutaneous
Intervention: Panobinostat
Intervention MeSH terms: Panobinostat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 139.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cutaneous T-Cell Lymphoma, adults; Mycosis Fungoides; Sézary Syndrome; CTCL

Summary:

      This study will evaluate the safety and efficacy of LBH489B in adult patients with refractory
      Cutaneous T-Cell Lymphoma.
    

Eligibility criteria:

        Inclusion criteria:

          1. Written informed consent obtained prior to any screening procedures

          2. Age ≥ 18 years old

          3. Patients with biopsy-confirmed stages IB-IVA mycosis fungoides or Sézary syndrome.
             Patients with SS who have bone marrow involvement are also eligible.

          4. 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.

          5. Patients must have had disease progression on or following their most recent treatment
             regimen or an inadequate response to their most recent treatment regimen.

          6. 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:

          1. Prior treatment with an HDAC inhibitor.

          2. Patients with visceral disease including CNS involvement (i.e. stage IVB CTCL). Note;
             Patients with SS who have bone marrow involvement are eligible.

          3. Impaired cardiac function

          4. Concomitant use of drugs with a risk of causing torsades de pointes

          5. Patients who have received chemotherapy or any investigational drug or undergone major
             surgery < 4 weeks prior to starting study drug or who have not recovered from side
             effects of such therapy

          6. Less than 3 months since prior electron beam therapy

          7. Female patients who are pregnant or breast feeding, or patients of reproductive
             potential not using an effective method of birth control, and male patients whose
             sexual partners are women of childbearing potential not using effective birth control

          8. Uncontrolled hypertension

          9. Concomitant use of any anti-cancer therapy or radiation therapy. Low potency topical
             steroid use is permitted. Topical bexarotene use is prohibited during the trial

         10. Concomitant use of CYP3A4/5 inhibitors.

         11. Patients with unresolved diarrhea > CTCAE grade 1

         12. Impairment of gastrointestinal (GI) function or GI disease that may significantly
             alter the absorption of oral LBH589

         13. Other concurrent severe and/or uncontrolled medical conditions

         14. 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