A Phase II, Multicentre Study of Oral LBH589 in Patients With Chronic Phase Chronic Myeloid Leukemia With Resistant Disease Following Treatment With at Least Two BCR-ABL Tyrosine Kinase Inhibitors
Inclusion Criteria
Inclusion criteria:
- 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
Exclusion criteria:
- 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