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Panobinostat (LBH589) and Imatinib Mesylate in Treating Patients With Previously Treated Chronic Phase Chronic Myelogenous Leukemia

Panobinostat and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth
Recruitment period: 
1 May 2008 to 1 August 2014
Trial period: 
1 May 2008 to 1 August 2014
Clinical Trial reference link: 
NCT00686218

Treatments:

For newly diagnosed patients: 
no

This study has been completed

Primary 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.

Trial Description: Phase 1

Last verified: April 2014

Sponsor: City of Hope Medical Center

Collaborator: National Cancer Institute (NCI)

Primary objectives

  • 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 objectives

  • 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 objectives

  • 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.

http://www.cancer.gov/clinicaltrials/search/view?cdrid=596065&version=He...