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

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)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01242774

Enrollment

Registered

2010-11-17

Start date

2010-10-31

Completion date

2014-05-31

Last updated

2020-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia (AML)

Keywords

AML, bone marrow, abnormal blast cells of myeloid, acute leukemia, cytogenetic abnormalities, HDACi

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.

Interventions

DRUGPanobinostat

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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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/

Design outcomes

Primary

Measure	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

Measure	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

Countries

Germany, Spain, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026