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

NCT01242774 | Completed Phase 1

• 2 other identifiers: CLBH589G21012009-016809-42
• Study Type: interventional
• Target: 46
• Locations: 3 countries
• Sites: 10

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.

Conditions

Acute Myeloid Leukemia (AML)

Keywords

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

Outcome Measures

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.

  1 year

Secondary Outcomes (3)

• 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

Study Arms (1)

Panobinostat

EXPERIMENTAL

Drug: Panobinostat

Interventions

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.

Also known as: LBH589

Panobinostat

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• º or 2º AML patients with high-risk category features
• ECOG PS = 2
• Renal function and liver function limits.

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (10)

Stanford University Medical Center Stanford U

Stanford, California, 94304, United States

Location

Dana Farber Cancer Institute Beth Israel Deaconess Med Ctr

Boston, Massachusetts, 02115, United States

Location

Ohio State Comprehensive Cancer Center/James Cancer Hospital Dept.ofJamesCancerHospital

Columbus, Ohio, 43210, United States

Location

Medical University of South Carolina -Hollings Cancer Center MUSC/HCC (2)

Charleston, South Carolina, 29425, United States

Location

Vanderbilt University Medical Center, Clinical Trials Center Vanderbilt 3

Nashville, Tennessee, 37212, United States

Location

Novartis Investigative Site

Dresden, 01307, Germany

Location

Novartis Investigative Site

Hanover, 30625, Germany

Location

Novartis Investigative Site

Ulm, 89081, Germany

Location

Novartis Investigative Site

Salamanca, Castille and León, 37007, Spain

Location

Novartis Investigative Site

Barcelona, 08025, Spain

Location

Related Publications (1)

• DeAngelo DJ, Walker AR, Schlenk RF, Sierra J, Medeiros BC, Ocio EM, Rollig C, Strickland SA, Thol F, Valera SZ, Dasgupta K, Berkowitz N, Stuart RK. Safety and efficacy of oral panobinostat plus chemotherapy in patients aged 65 years or younger with high-risk acute myeloid leukemia. Leuk Res. 2019 Oct;85:106197. doi: 10.1016/j.leukres.2019.106197. Epub 2019 Aug 1.

  PMID: 31541945 DERIVED

Related Links

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

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Chromosome Aberrations

Interventions

Panobinostat

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydroxamic Acids; Hydroxylamines; Amines; Organic Chemicals; Hydroxy Acids; Carboxylic Acids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2010
• First Posted: November 17, 2010
• Study Start: October 1, 2010
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: December 19, 2020

Record last verified: 2015-05

Locations

DE (3); ES (2); US (5)