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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00451035
Recruitment Status : Completed
First Posted : March 22, 2007
Last Update Posted : November 18, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Myeloid Leukemia in Chronic Phase Drug: LBH589 Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2007
Actual Primary Completion Date : September 2008


Arm Intervention/treatment
Experimental: 1 Drug: LBH589
Other Name: panobinostat




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

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


Information from the National Library of Medicine

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00451035


Locations
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Belgium
Novartis Investigative Site
Bruxelles, Belgium
Novartis Investigative Site
Godinne, Belgium
Novartis Investigative Site
Leuven, Belgium
Germany
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
Investigators
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Study Director: Novartis Pharmaceuticlas Novartis Pharmaceuticals

Additional Information:
Publications of Results:
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00451035    
Other Study ID Numbers: CLBH589B2202
First Posted: March 22, 2007    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: November 2016
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Refractory Chronic Myeloid Leukemia in Chronic Phase
adults
oral LBH589
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Panobinostat
Antineoplastic Agents
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action