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Efficacy and Safety of LBH589 in Adult Patients With Refractory Chronic Myeloid Leukemia (CML) in Chronic Phase

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: March 20, 2007
Last updated: November 16, 2016
Last verified: November 2016
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

Condition Intervention Phase
Chronic Myeloid Leukemia in Chronic Phase
Drug: LBH589
Phase 2
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Major (complete/partial) cytogenetic response assessed by bone marrow assessment [ Time Frame: Every 2 months ]

Secondary Outcome Measures:
  • Duration of major cytogenetic response (MCyR) [ Time Frame: Every 2 months ]
  • Complete hematologic response (CHR) rate assessed by a blood test [ Time Frame: twice weekly during cycle 1 then weekly for subsequent cycle ]
  • Complete cytogenetic response (CCyR) rate assessed by bone marrow assessment [ Time Frame: Every 2 months ]
  • Overall (complete/partial/minor/minimal) cytogenetic response rate assessed by bone marrow assessment [ Time Frame: Every 2 months ]
  • Major and complete molecular response rates assessed by a blood test [ Time Frame: Every 2 months ]

Enrollment: 29
Study Start Date: January 2007
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: LBH589
Other Name: panobinostat


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00451035

Novartis Investigative Site
Bruxelles, Belgium
Novartis Investigative Site
Godinne, Belgium
Novartis Investigative Site
Leuven, Belgium
Novartis Investigative Site
Cologne, Germany
Novartis Investigative Site
Dusseldorf, Germany
Novartis Investigative Site
Hamburg, Germany
Novartis Investigative Site
Leipzig, Germany
Novartis Investigative Site
Mainz, Germany
Novartis Investigative Site
Mannheim, Germany
Novartis Investigative Site
Munich, Germany
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticlas Novartis Pharmaceuticals
  More Information

Additional Information:
Responsible Party: Novartis Pharmaceuticals Identifier: NCT00451035     History of Changes
Other Study ID Numbers: CLBH589B2202
Study First Received: March 20, 2007
Last Updated: November 16, 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Refractory Chronic Myeloid Leukemia in Chronic Phase
oral LBH589

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic-Phase
Neoplasms by Histologic Type
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Antineoplastic Agents
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017