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

Primary Purpose

Acute Myeloid Leukemia (AML)

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Panobinostat
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia (AML) focused on measuring AML, bone marrow, abnormal blast cells of myeloid, acute leukemia, cytogenetic abnormalities, HDACi

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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/exclusion criteria may apply

Sites / Locations

  • Stanford University Medical Center Stanford U
  • Dana Farber Cancer Institute Beth Israel Deaconess Med Ctr
  • Ohio State Comprehensive Cancer Center/James Cancer Hospital Dept.ofJamesCancerHospital
  • Medical University of South Carolina -Hollings Cancer Center MUSC/HCC (2)
  • Vanderbilt University Medical Center, Clinical Trials Center Vanderbilt 3
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Panobinostat

Arm Description

Outcomes

Primary Outcome Measures

Define the maximum tolerated dose of Panobinostat (LBH589) that can be given with standard idarubicin and ara-C chemotherapy measured by safety and tolerability.

Secondary Outcome Measures

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

Full Information

First Posted
October 17, 2010
Last Updated
December 16, 2020
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01242774
Brief Title
Safety & Efficacy Study of Oral Panobinostat (LBH589) With Chemotherapy in Patients < 65 Years Old With Acute Myeloid Leukemia (AML)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia (AML)
Keywords
AML, bone marrow, abnormal blast cells of myeloid, acute leukemia, cytogenetic abnormalities, HDACi

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Panobinostat
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Panobinostat
Other Intervention Name(s)
LBH589
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
To determine the number of patients who have safety and tolerability events
Time Frame
1 year
Title
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
Title
To determine the response of Panobinostat (LBH589) given with standard idarubicin and ara-C chemotherapy (as defined by Cheson 2003)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Stanford University Medical Center Stanford U
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Dana Farber Cancer Institute Beth Israel Deaconess Med Ctr
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Ohio State Comprehensive Cancer Center/James Cancer Hospital Dept.ofJamesCancerHospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Medical University of South Carolina -Hollings Cancer Center MUSC/HCC (2)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Vanderbilt University Medical Center, Clinical Trials Center Vanderbilt 3
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Novartis Investigative Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Novartis Investigative Site
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Novartis Investigative Site
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Novartis Investigative Site
City
Salamanca
State/Province
Castilla Y Leon
ZIP/Postal Code
37007
Country
Spain
Facility Name
Novartis Investigative Site
City
Barcelona
ZIP/Postal Code
08025
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
31541945
Citation
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.
Results Reference
derived
Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=13744
Description
Results for CLBH589G2101 can be found on the Novartis Clinical Trial Results Website

Learn more about this trial

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

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