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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


Phase 2/Phase 3
18 Years
N/A
Not Enrolling
Both
Chronic Myeloid Leukemia in Chronic Phase

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Trial Information

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

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Major (complete/partial) cytogenetic response assessed by bone marrow assessment

Outcome Time Frame:

Every 2 months

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticlas

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Study ID:

CLBH589B2202

NCT ID:

NCT00451035

Start Date:

January 2007

Completion Date:

Related Keywords:

  • Chronic Myeloid Leukemia in Chronic Phase
  • Refractory Chronic Myeloid Leukemia in Chronic Phase
  • adults
  • oral LBH589
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Myeloid, Chronic-Phase

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