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Efficacy and Safety of Panobinostat (LBH589) in Patients With Refractory de Novo or Secondary Acute Myelogenous Leukemia (AML)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00880269
First received: March 30, 2009
Last updated: October 23, 2016
Last verified: September 2016
Results First Received: July 21, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Refractory Leukemia
Acute Myelogenous Leukemia
Intervention: Drug: Panobinostat/LBH589

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participant flow is based on the full analysis set (FAS) which is the same as the safety set and includes on does of the study drug.

Reporting Groups
  Description
Stratum A patients with refractory acute myelogenous leukemia (AML) initially diagnosed as de novo AML received 60 mg of panobinostat per day on three discontinuous days per week.
Stratum B patients with refractory AML initially diagnosed as AML secondary to myelodysplastic syndrome (MDS)/antecedent hematologic disorder (AHD) received 60 mg of panobinostat per day on three discontinuous days per week.

Participant Flow:   Overall Study
    Stratum A   Stratum B
STARTED   32   27 
Discontinued Treatment   32   27 
COMPLETED   0   0 
NOT COMPLETED   32   27 
Protocol Violation                1                0 
Disease Progression                13                11 
New Cancer Therapy                1                0 
Death                4                2 
Lost to Follow-up                0                1 
Withdrawal by Subject                3                4 
Adverse Event                10                9 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Stratum A patients with refractory acute myelogenous leukemia (AML) initially diagnosed as de novo AML received 60 mg of panobinostat per day on three discontinuous days per week.
Stratum B patients with refractory AML initially diagnosed as AML secondary to myelodysplastic syndrome (MDS)/antecedent hematologic disorder (AHD) received 60 mg of panobinostat per day on three discontinuous days per week.
Total Total of all reporting groups

Baseline Measures
   Stratum A   Stratum B   Total 
Overall Participants Analyzed 
[Units: Participants]
 32   27   59 
Age 
[Units: Years]
Mean (Standard Deviation)
 63  (12.13)   68.5  (7.75)   65.5  (10.65) 
Gender 
[Units: Participants]
Count of Participants
     
Female      20  62.5%      8  29.6%      28  47.5% 
Male      12  37.5%      19  70.4%      31  52.5% 


  Outcome Measures
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1.  Primary:   Best Response as Per Investigator Assessment by Stratum (FAS)   [ Time Frame: 6 cycles of treatment with a 28-day treatment cycle (Day 168) ]

2.  Secondary:   Partial Response Measured in Stratum A and B   [ Time Frame: 6 treatment cycles (28-day/treatment cycle) ]

3.  Secondary:   Time to Remission Measured in Stratum A and B   [ Time Frame: 6 treatment cycles (28-day/treatment cycle) ]

4.  Secondary:   Duration of Remission Measured in Stratum A and B   [ Time Frame: 6 treatment cycles (28-day/treatment cycle) ]

5.  Secondary:   Event-free Survival Measured in Stratum A and B   [ Time Frame: 6 treatment cycles (28-day/treatment cycle) ]

6.  Secondary:   Overall Survival Measured in Stratum A and B   [ Time Frame: 6 treatment cycles (28-day/treatment cycle) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300



Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00880269     History of Changes
Other Study ID Numbers: CLBH589B2213
2008-002983-32 ( EudraCT Number )
Study First Received: March 30, 2009
Results First Received: July 21, 2016
Last Updated: October 23, 2016
Health Authority: United States: Food and Drug Administration