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Study of Oral LBH589 in Adult Participants With Refractory/Resistant Cutaneous T-Cell Lymphoma (CTCL)
Trial ID: NCT00490776
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.
A Phase II Study of Oral LBH589 in Adult Patients With Cutaneous T-Cell Lymphoma Who Are Intolerant to or Have Progressed on or After Prior HDAC Inhibitor
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
6. ECOG performance status ≤ 2
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.
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