Efficacy and Safety of LBH589 in Adult Patients With Refractory Chronic Myeloid Leukemia (CML) in Chronic Phase
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This study will evaluate the efficacy and safety of LBH589B in adult patients with chronic phase chronic myeloid leukemia with resistant disease following treatment with at least two BCR-ABL tyrosine kinase inhibitors
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Male or female patients aged ≥ 18 years old
Diagnosis of Philadelphia chromosome positive, chronic phase chronic myeloid leukemia
Prior treatment with at least two BCR-ABL tyrosine kinase inhibitors with demonstrated resistance to the most recent kinase inhibitor therapy.
Patients with a history of intolerance to one BCR-ABL kinase inhibitors will be considered eligible to enter the study if they demonstrate resistance to their most recent BCR-ABL kinase inhibitor.
Patients who are intolerant of at least 2 BCR-ABL kinase inhibitors will be considered eligible to enter this study if they also demonstrate resistance to or intolerance of interferon-alpha (IFN-α) by the same criteria defined above.
Patients must have adequate laboratory values
Baseline measurement of left ventricular ejection fraction [assessment of the hearts ability to pump effectively]
Assessment of patients ability to perform every day activities. Assessment by the ECOG [Eastern Cooperative Oncology Group] Performance Status
A candidate for hematopoietic stem cell transplantation
Prior therapy with certain medications
Patients with a prior history of accelerated phase or blast crisis CML
Impaired cardiac function or clinically significant cardiac diseases
Concomitant use of certain medications
Impairment of GI function or GI disease
Patients with unresolved diarrhea
Patients who have received chemotherapy, any investigational drugs or undergone major surgery < 4 weeks prior to starting study drug or who have not recovered from side effects of such therapy
Patients who have received a BCR-ABL tyrosine-kinase inhibitor within 1 week of first treatment with LBH589
Women who are pregnant or breast feeding or women of childbearing potential not using an effective method of birth control
Male patients whose sexual partners are women of child bearing potential not using effective birth control
Other protocol-defined inclusion/exclusion criteria may apply