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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00451035
First received: March 20, 2007
Last updated: February 9, 2013
Last verified: February 2013
  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 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
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:

Primary Outcome Measures:
  • Major (complete/partial) cytogenetic response assessed by bone marrow assessment [ Time Frame: Every 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of major cytogenetic response (MCyR) [ Time Frame: Every 2 months ] [ Designated as safety issue: No ]
  • Complete hematologic response (CHR) rate assessed by a blood test [ Time Frame: twice weekly during cycle 1 then weekly for subsequent cycle ] [ Designated as safety issue: Yes ]
  • Complete cytogenetic response (CCyR) rate assessed by bone marrow assessment [ Time Frame: Every 2 months ] [ Designated as safety issue: No ]
  • Overall (complete/partial/minor/minimal) cytogenetic response rate assessed by bone marrow assessment [ Time Frame: Every 2 months ] [ Designated as safety issue: No ]
  • Major and complete molecular response rates assessed by a blood test [ Time Frame: Every 2 months ] [ Designated as safety issue: No ]

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

  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 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 ClinicalTrials.gov identifier: NCT00451035

Locations
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
Study Director: Novartis Pharmaceuticlas Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00451035     History of Changes
Other Study ID Numbers: CLBH589B2202
Study First Received: March 20, 2007
Last Updated: February 9, 2013
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
Denmark: Danish Medicines Agency
European Union: European Medicines Agency
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Italy: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation
South Africa: Department of Health
Spain: Spanish Agency of Medicines
Netherlands: Medicines Evaluation Board (MEB)
United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Leukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Leukemia, Myeloid, Chronic-Phase
Bone Marrow Diseases
Hematologic Diseases
Myeloproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Panobinostat
Antineoplastic Agents
Enzyme Inhibitors
Histone Deacetylase Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014