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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


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

Thank you

Trial Information

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

Inclusion 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Hematologic response (complete hematologic response (CHR) / no evidence of leukemia (NEL) / return to chronic phase (RTC)) rate assessed by a blood test

Outcome Time Frame:

throughout the study

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Study ID:

CLBH589B2211

NCT ID:

NCT00449761

Start Date:

February 2007

Completion Date:

Related Keywords:

  • Leukemia, Myeloid, Chronic
  • Refractory
  • Chronic Myeloid
  • Leukemia
  • accelerated phase
  • blast phase (blast crisis)
  • adults
  • oral LBH589
  • Blast Crisis
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Name

Location

University of MichiganAnn Arbor, Michigan  48109-0624
Roswell Park Cancer InstituteBuffalo, New York  14263
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Rush University Medical CenterChicago, Illinois  60612-3824
University of Rochester Medical CenterRochester, New York  14642
Rocky Mountain Cancer CenterDenver, Colorado  80218
City of Hope National Medical CenterLos Angeles, California  91010
Seattle Cancer Care AllianceSeattle, Washington  98109
Oregon Health & Science UniversityPortland, Oregon  97201
University of Texas Southwestern Medical CenterDallas, Texas  
Wake Forest University Health SciencesWinston-Salem, North Carolina  27157
Duke University HospitalDurham, North Carolina  27710
University Chicago HospitalChicago, Illinois  60637
University of Colorado Health Sciences Center/Anschutz Cancer PavilionAurora, Colorado  80010
Northwestern University Clinical Research OfficeChicago, Illinois  60611
Indiana Blood and Marrow Institute/St. Francis HospitalBeech Grove, Indiana  46107
Hackensack University Medical Center/Oncology Research Dept.Hackensack, New Jersey  07601
Emory University School of Medicine-Winship Cancer InstituteNashville, Tennessee  37212
Vanderbilt University Medical Center, Clinical Trials CenterNashville, Tennessee  37212