Study of Oral LBH589 in Adult Participants With Refractory/Resistant Cutaneous T-Cell Lymphoma (CTCL)
Condition: Cutaneous T-Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Lymphoma, T-Cell, Cutaneous
Intervention: Panobinostat
Intervention description: Panobinostat, 20 mg, hard gelatin capsules, orally, thrice weekly.
Intervention MeSH terms: Panobinostat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cutaneous T-Cell Lymphoma; adults; Mycosis Fungoides; Sézary Syndrome; CTCL

Summary:

      This study evaluated the safety and efficacy of LBH589B in adult participants with
      refractory/resistant Cutaneous T-Cell Lymphoma and prior Histone Deacetylase (HDAC) inhibitor
      therapy.
    

Eligibility criteria:

        Inclusion criteria:

          1. Written informed consent obtained prior to any screening procedures

          2. Age greater than or equal to 18 years old

          3. Participants with biopsy-confirmed stages IB-IVA mycosis fungoides or Sézary syndrome
             (SS). Participants with SS who have bone marrow involvement are also eligible.
             Participants with transformed CTCL are eligible

          4. Participants must have been treated with an HDAC inhibitor given for the treatment of
             CTCL. Participants must have had disease progression on or following treatment with an
             HDAC inhibitor. Participants are also eligible if they had an inadequate response to
             an HDAC inhibitor defined as stable disease as the best response after at least 3
             months of therapy. Participants previously treated with an HDAC inhibitor are also
             eligible if they experienced intolerance due to adverse events.

          5. Baseline multiple-gated acquisition scan (MUGA) or echocardiogram must have
             demonstrated left ventricular ejection fraction (LVEF) ≥ the lower limit of the
             institutional normal

          6. ECOG performance status ≤ 2

        Exclusion criteria:

          1. Participants with a history of visceral disease including central nervous system (CNS)
             involvement (i.e. stage IVB CTCL). Note, participants who have SS with bone marrow
             involvement are eligible

          2. Impaired cardiac function

          3. Concomitant use of drugs with a risk of causing torsades de pointes

          4. Participants who have received chemotherapy or any investigational drug or undergone
             major surgery ≤ 3 weeks prior to starting study drug or who have not recovered from
             side effects of such therapy

          5. Less than 3 months since prior electron beam therapy

          6. Women who are pregnant or breast feeding, or women of childbearing potential (WOCBP)
             not willing to use a double method of contraception during the study and 3 months
             after the end of treatment.

        Other protocol-defined inclusion/exclusion criteria may apply.