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Safety & Efficacy Study of Oral Panobinostat (LBH589) With Chemotherapy in Patients < 65 Years Old With Acute Myeloid Leukemia (AML)

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: NCT01242774
Recruitment Status : Completed
First Posted : November 17, 2010
Last Update Posted : December 19, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
This study will be conducted to assess the maximum tolerated dose (MTD) of panobinostat given 3 times a week (administered on weeks 2 and 3 of a 4 week cycle) in combination with induction chemotherapy (idarubicin and cytarabine) in newly diagnosed patients with a cytopathologically confirmed diagnosis of high-risk AML, and to investigate the safety of the combination in this regimen.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia (AML) Drug: Panobinostat Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ib, Dose-finding Study of Oral Panobinostat (LBH589) in Combination With Idarubicin and Cytarabine Induction and High-dose Cytarabine-based Consolidation Therapy in Adult Patients Less Than or Equal to 65 Years Old With Acute Myeloid Leukemia (AML)
Study Start Date : October 2010
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Panobinostat Drug: Panobinostat
Oral administration of panobinostat given 3 times a week (administered on weeks 2 and 3 of a 4 week cycle) in combination with induction chemotherapy (idarubicin and cytarabine.
Other Name: LBH589


Outcome Measures
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Primary Outcome Measures :
  1. Define the maximum tolerated dose of Panobinostat (LBH589) that can be given with standard idarubicin and ara-C chemotherapy measured by safety and tolerability. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. To determine the number of patients who have safety and tolerability events [ Time Frame: 1 year ]
  2. To determine Panobinostat's pharmacokinetic parameters (study the amount of Panobinostat in a person's blood over time) following study treatments [ Time Frame: 1 year ]
  3. To determine the response of Panobinostat (LBH589) given with standard idarubicin and ara-C chemotherapy (as defined by Cheson 2003) [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly diagnosed adult patients = 65 years old with a cytopathologically confirmed diagnosis of high-risk AML
  • = 20% bone marrow blasts via bone marrow aspiration or biopsy
  • The patient has not yet been treated for AML
  • 1º or 2º AML patients with high-risk category features
  • ECOG PS = 2
  • Renal function and liver function limits.

Exclusion Criteria:

  • Patient with a 'favorable' or 'better-risk' cytogenetic profile = t(15;17); t(8;21); or inv(16) or t(16;16)
  • Patient has clinical symptoms suggestive of CNS leukemia and/or CSF findings for CNS leukemia
  • Prior treatment with deacetylase inhibitors (DACi) including, panobinostat
  • Impaired cardiac function
  • Female patient who is pregnant or breast feeding
  • Male patient who is not willing to use a barrier method of contraception

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations
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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): NCT01242774


Locations
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United States, California
Stanford University Medical Center Stanford U
Stanford, California, United States, 94304
United States, Massachusetts
Dana Farber Cancer Institute Beth Israel Deaconess Med Ctr
Boston, Massachusetts, United States, 02115
United States, Ohio
Ohio State Comprehensive Cancer Center/James Cancer Hospital Dept.ofJamesCancerHospital
Columbus, Ohio, United States, 43210
United States, South Carolina
Medical University of South Carolina -Hollings Cancer Center MUSC/HCC (2)
Charleston, South Carolina, United States, 29425
United States, Tennessee
Vanderbilt University Medical Center, Clinical Trials Center Vanderbilt 3
Nashville, Tennessee, United States, 37212
Germany
Novartis Investigative Site
Dresden, Germany, 01307
Novartis Investigative Site
Hannover, Germany, 30625
Novartis Investigative Site
Ulm, Germany, 89081
Spain
Novartis Investigative Site
Salamanca, Castilla Y Leon, Spain, 37007
Novartis Investigative Site
Barcelona, Spain, 08025
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01242774    
Other Study ID Numbers: CLBH589G2101
2009-016809-42 ( EudraCT Number )
First Posted: November 17, 2010    Key Record Dates
Last Update Posted: December 19, 2020
Last Verified: May 2015
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
AML
bone marrow
abnormal blast cells of myeloid
 acute leukemia
cytogenetic abnormalities
HDACi
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
 Panobinostat
Antineoplastic Agents
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action