Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety of LBH589B in Adult Patients With Refractory Chronic Myeloid Leukemia (CML) in Accelerated Phase or Blast Phase (Blast Crisis)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00449761
Recruitment Status : Completed
First Posted : March 21, 2007
Last Update Posted : November 18, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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 or disease Intervention/treatment Phase
Leukemia, Myeloid, Chronic Drug: panobinostat Phase 2 Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : February 2007
Actual Primary Completion Date : August 2008


Arm Intervention/treatment
Experimental: Panobinostat Drug: panobinostat
LBH589




Primary Outcome Measures :
  1. Hematologic response (complete hematologic response (CHR) / no evidence of leukemia (NEL) / return to chronic phase (RTC)) rate assessed by a blood test [ Time Frame: throughout the study ]

Secondary Outcome Measures :
  1. Duration of the hematologic response and cytogenetic response [ Time Frame: throughout the study ]
  2. Complete cytogenetic response (CCyR) rate assessed by bone marrow assessment [ Time Frame: throughout the study ]
  3. Major (complete/partial) cytogenetic response rate assessed by bone marrow assessment [ Time Frame: throughout the study ]
  4. Overall (complete/partial/minor/minimal) cytogenetic response rate assessed by bone marrow assessment [ Time Frame: throughout the study ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00449761


  Hide Study Locations
Locations
Layout table for location information
United States, California
City of Hope National Medical Center
Duarte, California, United States, 91010
United States, Colorado
University of Colorado Health Sciences Center/Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80010
Rocky Mountain Cancer Center
Denver, Colorado, United States, 80218
United States, Illinois
Northwestern University Clinical Research Office
Chicago, Illinois, United States, 60611
Rush University Medical Center
Chicago, Illinois, United States, 60612
University Chicago Hospital
Chicago, Illinois, United States, 60637
United States, Indiana
Indiana Blood and Marrow Institute/St. Francis Hospital
Beech Grove, Indiana, United States, 46107
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Mayo Clinic Cancer Center
West Rochester, Minnesota, United States, 55905
United States, New Jersey
Hackensack University Medical Center/Oncology Research Dept.
Hackensack, New Jersey, United States, 07601
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, North Carolina
Duke University Hospital
Durham, North Carolina, United States, 27710
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Tennessee
Emory University School of Medicine-Winship Cancer Institute
Nashville, Tennessee, United States, 37212
Vanderbilt University Medical Center, Clinical Trials Center
Nashville, Tennessee, United States, 37212
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Germany
Novartis Investigative Site
Cologne, Germany
Novartis Investigative Site
Duesseldorf, 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
Layout table for investigator information
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
Publications of Results:
Layout table for additonal information
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00449761     History of Changes
Other Study ID Numbers: CLBH589B2211
First Posted: March 21, 2007    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: November 2016
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Refractory
Chronic Myeloid
Leukemia
accelerated phase
blast phase (blast crisis)
adults
oral LBH589
Additional relevant MeSH terms:
Layout table for MeSH terms
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Blast Crisis
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Cell Transformation, Neoplastic
Carcinogenesis
Neoplastic Processes
Pathologic Processes
Panobinostat
Antineoplastic Agents
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action