Efficacy and Safety of LBH589B in Adult Patients With Refractory Chronic Myeloid Leukemia (CML) in Accelerated Phase or Blast Phase (Blast Crisis)
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This study will evaluate the efficacy and safety of LBH589B in adult patients with chronic myeloid leukemia who are in accelerated phase or blast phase (blast crisis) with resistant disease following treatment with at least two BCR-ABL tyrosine kinase inhibitors
A Phase II, Multicentre Study of Oral LBH589 in Patients With Accelerated Phase or Blast Phase (Blast Crisis) Chronic Myeloid Leukemia With Resistant Disease Following Treatment With at Least Two BCR-ABL Tyrosine Kinase Inhibitors
Study Start Date :
Actual Primary Completion Date :
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Male or female patients aged ≥ 18 years old
Diagnosis of Philadelphia chromosome positive accelerated or blast phase chronic myeloid leukemia defined as:
Accelerated phase - the presence of at least one of the following:
≥15% but <30% blasts in blood or bone marrow
≥30% blasts plus promyelocytes in peripheral blood or bone marrow (providing that <30% blasts present in bone marrow)
≥ 20% basophiles in the peripheral blood
Thrombocytopenia <100 X 109 /L unrelated to therapy
Blast phase (blast crisis) - the presence of one of the following:
≥ 30% blasts in the blood, marrow or both
Extramedullary infiltrates of leukemic cells
Prior treatment with at least two BCR-ABL tyrosine kinase inhibitors (i.e., imatinib, nilotinib, or dasatinib) and demonstrated resistance to the most recent kinase inhibitor therapy.
Patients with a history of intolerance to one BCR-ABL kinase inhibitors (defined as discontinuation of treatment due grade 3 or 4 adverse events related to treatment) will be considered eligible to enter the study if they demonstrate resistance to their most recent BCR-ABL kinase inhibitor.
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 hematopoitic stem cell transplantation
Prior therapy with certain medications
Patients who are in chronic phase chronic myeloid leukemia
Impaired cardiac function or clinically significant cardiac diseases
Concomitant use of drugs with a risk of possible risk of causing QTc prolongation or torsades de pointes
Concomitant use of certain medications
Impairment of GI function or GI disease
Patients with unresolved diarrhea
Patients who have received chemotherapy, any investigational drugs (other than BCR-ABL tyrosine kinase inhibitors) 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