Leukemia Clinical Trial
Official title:
A Phase I Dose Escalation Study of LBH589 in Combination With Imatinib Mesylate for Patients With Chronic Myeloid Leukemia in Cytogenetic Remission With Residual Disease Detectable by Q-PCR
RATIONALE: Panobinostat and imatinib mesylate may stop the growth of cancer cells by
blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of panobinostat when
given together with imatinib in treating patients with previously treated chronic phase
chronic myelogenous leukemia.
OBJECTIVES:
Primary
- To determine the safety and tolerability of LBH589 given in combination with imatinib
mesylate in CML patients who are in Major Cytogenetic Remission (MCR) with residual
BCR-ABL positive cells after at least 1 year of daily imatinib mesylate treatment.
- To determine the maximum tolerated dose (MTD) and dose-limiting toxicity of LBH589
given in combination with imatinib mesylate in CML patients.
Secondary
- To study the effect of LBH589 given in combination with imatinib mesylate on
cytogenetic response status and BCR-ABL levels in CML patients in major cytogenetic
remission on imatinib mesylate treatment.
Tertiary
- To study the effect of LBH589 given in combination with imatinib mesylate on residual
BCR-ABL positive primitive progenitors in CML patients in major cytogenetic remission
on imatinib mesylate treatment.
OUTLINE: This is dose-escalation study of panobinostat.
Patients receive oral panobinostat once daily on days 1, 3 and 5; 8, 10, and 12; 15, 17, and
19; and 22, 24, and 26. Patients also receive oral imatinib mesylate once daily on days
1-28. Treatment repeats every 21 or 28 days for up to 4 courses in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 1 month and then every 3
months for up to 1 year.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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