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Efficacy and Safety of LBH589B in Adult Patients With Refractory Chronic Myeloid Leukemia (CML) in Accelerated Phase or Blast Phase (Blast Crisis)
This study has been completed.
Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00449761
  Purpose

This study will evaluate the efficacy and safety of LBH589B in adult patients with chronic myeloid leukemia who are in accelerated phase or blast phase (blast crisis) with resistant disease following treatment with at least two BCR-ABL tyrosine kinase inhibitors


Condition Intervention Phase
Leukemia, Myeloid, Chronic
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 Accelerated Phase or Blast Phase (Blast Crisis) 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:
  • Hematologic response (complete hematologic response (CHR) / no evidence of leukemia (NEL) / return to chronic phase (RTC)) rate assessed by a blood test

Secondary Outcome Measures:
  • Duration of the hematologic response and cytogenetic response
  • Complete cytogenetic response (CCyR) rate assessed by bone marrow assessment
  • Major (complete/partial) cytogenetic response rate assessed by bone marrow assessment
  • Overall (complete/partial/minor/minimal) cytogenetic response rate assessed by bone marrow assessment

Estimated Enrollment: 71
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 accelerated or blast phase chronic myeloid leukemia defined as:
  • Accelerated phase - the presence of at least one of the following:
  • ≥15% but <30% blasts in blood or bone marrow
  • ≥30% blasts plus promyelocytes in peripheral blood or bone marrow (providing that <30% blasts present in bone marrow)
  • ≥ 20% basophiles in the peripheral blood
  • Thrombocytopenia <100 X 109 /L unrelated to therapy
  • Blast phase (blast crisis) - the presence of one of the following:
  • ≥ 30% blasts in the blood, marrow or both
  • Extramedullary infiltrates of leukemic cells
  • Prior treatment with at least two BCR-ABL tyrosine kinase inhibitors (i.e., imatinib, nilotinib, or dasatinib) and demonstrated resistance to the most recent kinase inhibitor therapy.
  • Patients with a history of intolerance to one BCR-ABL kinase inhibitors (defined as discontinuation of treatment due grade 3 or 4 adverse events related to treatment) will be considered eligible to enter the study if they demonstrate resistance to their most recent BCR-ABL kinase inhibitor.
  • 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 who are in chronic phase chronic myeloid leukemia
  • Impaired cardiac function or clinically significant cardiac diseases
  • Concomitant use of drugs with a risk of possible risk of causing QTc prolongation or torsades de pointes
  • Concomitant use of certain medications
  • Impairment of GI function or GI disease
  • Patients with unresolved diarrhea
  • Patients who have received chemotherapy, any investigational drugs (other than BCR-ABL tyrosine kinase inhibitors) 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: NCT00449761

  Show 26 Study Locations
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Novartis
  More Information

Responsible Party: Novartis ( External Affairs )
Study ID Numbers: CLBH589B2211
Study First Received: March 20, 2007
Last Updated: December 8, 2008
ClinicalTrials.gov Identifier: NCT00449761  
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica;   Australia: Department of Health and Ageing Therapeutic Goods Administration;   Belgium: Pharmaceutical Inspectorate;   Canada: Health Products and Food Branch;   Denmark: Danish 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;   Netherlands: Medicines Evaluation Board (MEB);   United States: Food and Drug Administration

Keywords provided by Novartis:
Refractory
Chronic Myeloid
Leukemia
accelerated phase
blast phase (blast crisis)
adults
oral LBH589

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

Additional relevant MeSH terms:
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Histologic Type
Cell Transformation, Neoplastic

ClinicalTrials.gov processed this record on January 14, 2009