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Completed

NCT Number: NCT01242774

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

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.

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Key information

Conditions

Acute Myeloid Leukemia (AML) Chromosome Aberrations Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Dresden, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Panobinostat

Drug

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 names: LBH589

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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)

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Nov 17, 2010
Registry last updated
Dec 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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