Study of Oral LBH589 in Adult Patients With Refractory/Resistant Cutaneous T-Cell Lymphoma
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To determine the overall response rate of patients treated with LBH589 by using the modified Severity-Weighted Assessment Tool to assess skin disease and the evaluation of disease in the viscera, lymph nodes, and blood (circulation SS cells) [ Time Frame: Monthly ]
Secondary Outcome Measures :
To determine the response rate using the Physicians Global Assessment of Clinical Condition(PGA)of patients with resistant CTCL [ Time Frame: Monthly ]
To determine the response rate using Modified Severity Weighted Assessment (mSWAT) skin score of patients with resistant CTCL [ Time Frame: Monthly ]
Responses in index lesions by lesion measurements with photographic supporting documentation [ Time Frame: Monthly ]
Overall response rate of patients with resistant CTCL treated with oral LBH589 by using the modified Physician's Global Assessment (PGA) to assess skin disease and the evaluation of disease in the viscera, lymph nodes and blood (circulating SS cells). [ Time Frame: Monthly ]
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Written informed consent obtained prior to any screening procedures
Age greater than or equal to 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 with transformed CTCL are eligible.
Patients must have been treated with an HDAC inhibitor given for the treatment of CTCL. Patients must have had disease progression on or following treatment with an HDAC inhibitor. Patients 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. Patients previously treated with an HDAC inhibitor are also eligible if they experienced intolerance due to adverse events.
Patients with a history of visceral disease including CNS involvement (i.e. stage IVB CTCL). Note, patients who have SS with 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 ≤ 3 weeks prior to starting study drug or who have not recovered from side effects of such therapy
Less than 3 months since prior electron beam therapy
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