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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Acute Myeloid Leukemia (AML)

Intervention / Treatment
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* Drug: Panobinostat


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Panobinostat<br> | Drug: Panobinostat<br>* 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.<br>* Other names: LBH589;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AML, bone marrow, abnormal blast cells of myeloid, acute leukemia, cytogenetic abnormalities, HDACi