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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.
Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00451035
  Purpose

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 II
Phase III

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic
Drug Information available for: Tyrosine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Major (complete/partial) cytogenetic response assessed by bone marrow assessment

Secondary Outcome Measures:
  • Duration of major cytogenetic response (MCyR)
  • Complete hematologic response (CHR) rate assessed by a blood test
  • Complete cytogenetic response (CCyR) rate assessed by bone marrow assessment
  • Overall (complete/partial/minor/minimal) cytogenetic response rate assessed by bone marrow assessment
  • Major and complete molecular response rates assessed by a blood test

Estimated Enrollment: 120
Study Start Date: January 2007
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 hematopoitic 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00451035

Locations
Belgium
Leuven, Belgium
Bruxelles, Belgium
Godinne, Belgium
Germany
Mainz, Germany
Cologne, Germany
Munich, Germany
Hamburg, Germany
Mannheim, Germany
Leipzig, Germany
Dusseldorf, Germany
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Novartis
  More Information

Responsible Party: Novartis ( External Affairs )
Study ID Numbers: CLBH589B2202
Study First Received: March 20, 2007
Last Updated: August 18, 2008
ClinicalTrials.gov Identifier: NCT00451035  
Health Authority: Argentina: National Administration of Drugs, Foods, and Medical Technology;   Australia: Therapeutic Goods Administration;   Belgium: Pharmaceutical Inspectorate;   Canada: Health Products and Food Branch;   Denmark: Medicines Agency;   Europe : European agency for the evaluation of medicinal products (EMEA);   Finland: National Agency for Medicines;   France: Sanitary Safety of Health Products Agency;   Germany: Federal Institute for Drugs and Medical Devices;   Italy: Ministry of Health;   Poland: Drug Institute;   Russia: Ministry of Public Health;   South Africa: Department of Health;   Spain: Spanish Drug Agency;   The Netherlands: Medicines Evaluation Board;   United States: Food and Drug Administration

Keywords provided by Novartis:
Refractory Chronic Myeloid Leukemia in Chronic Phase
adults
oral LBH589

Study placed in the following topic categories:
Leukemia
Chronic myelogenous leukemia
Hematologic Diseases
Myeloproliferative Disorders
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic-Phase
Leukemia, Myeloid
Bone Marrow Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 14, 2009