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NCT01242774 Clinical Trial

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

Acute Myeloid Leukemia (AML) Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01242774
Other study ID # CLBH589G2101
Secondary ID 2009-016809-42
Status Completed
Phase Phase 1
First received
Last updated
Start date October 2010
Est. completion date May 2014

Study information
Verified date May 2015
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 46
Est. completion date May 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Germany Novartis Investigative Site Dresden
Germany Novartis Investigative Site Hannover
Germany Novartis Investigative Site Ulm
Spain Novartis Investigative Site Barcelona
Spain Novartis Investigative Site Salamanca Castilla Y Leon
United States Dana Farber Cancer Institute Beth Israel Deaconess Med Ctr Boston Massachusetts
United States Medical University of South Carolina -Hollings Cancer Center MUSC/HCC (2) Charleston South Carolina
United States Ohio State Comprehensive Cancer Center/James Cancer Hospital Dept.ofJamesCancerHospital Columbus Ohio
United States Vanderbilt University Medical Center, Clinical Trials Center Vanderbilt 3 Nashville Tennessee
United States Stanford University Medical Center Stanford U Stanford California

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Germany,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Define the maximum tolerated dose of Panobinostat (LBH589) that can be given with standard idarubicin and ara-C chemotherapy measured by safety and tolerability. 1 year
Secondary To determine the number of patients who have safety and tolerability events 1 year
Secondary To determine Panobinostat's pharmacokinetic parameters (study the amount of Panobinostat in a person's blood over time) following study treatments 1 year
Secondary To determine the response of Panobinostat (LBH589) given with standard idarubicin and ara-C chemotherapy (as defined by Cheson 2003) 1 year
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