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
• Start date: October 2010
• Est. completion date: May 2014

Study information

• Verified date: May 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• 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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia (AML)
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

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

External Links

•   Results for CLBH589G2101 can be found on the Novartis Clinical Trial Results Website