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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: January 8, 2017
Last verified: January 2017
History of Changes
March 30, 2009
January 8, 2017
August 2009
February 2012   (Final data collection date for primary outcome measure)
Best Response as Per Investigator Assessment by Stratum (FAS) [ Time Frame: 6 cycles of treatment with a 28-day treatment cycle (Day 168) ]
Response to treatment was defined as complete remission rate (CRR). CRR is complete remission (CR) and morphologic CR with incomplete blood count recovery (residual neutropenia or thrombocytopenia) (CRi). To stop or to proceed with Stage 2 of a given stratum of the Simon's optimal 2-stage design was based on the number of patients with CR/CRi and a safety evaluation of the patients from Stage 1 in that stratum. If early results clearly indicated that the drug was not active or worthy of further investigation, enrollment of that particular stratum would be terminated. CR and CRi were assessed by the Investigator according to IWG response Criteria for AML (Cheson et al 2003). As per protocol we would continue to stage II if ≥ 4 patients out of 26 patients enrolled to stage I had a CR or a CRi. As per response observed there was only 1 patient with CR/CRi in stratum A and 2 patients with CR/CRi in Stratum B.
CRR [complete remission rate (CR/CRi)] [ Time Frame: 6 months ]
Complete list of historical versions of study NCT00880269 on ClinicalTrials.gov Archive Site
  • Partial Response Measured in Stratum A and B [ Time Frame: 6 treatment cycles (28-day/treatment cycle) ]
    As predefined in the study's protocol, stage II was not pursued due to lack of activity (at end of stage I less than 4 patients in each stratum with CR/CRi)
  • Time to Remission Measured in Stratum A and B [ Time Frame: 6 treatment cycles (28-day/treatment cycle) ]
  • Duration of Remission Measured in Stratum A and B [ Time Frame: 6 treatment cycles (28-day/treatment cycle) ]
  • Event-free Survival Measured in Stratum A and B [ Time Frame: 6 treatment cycles (28-day/treatment cycle) ]
  • Overall Survival Measured in Stratum A and B [ Time Frame: 6 treatment cycles (28-day/treatment cycle) ]
  • To assess partial remission [ Time Frame: duration of study/after end of study ]
  • Time to remission and duration of remission [ Time Frame: duration of study ]
  • Event-free survival [ Time Frame: duration of study/after end of study ]
  • Overall survival [ Time Frame: duration of study/after end of study ]
  • safety and tolerability [ Time Frame: duration of study ]
Not Provided
Not Provided
 
Efficacy and Safety of Panobinostat (LBH589) in Patients With Refractory de Novo or Secondary Acute Myelogenous Leukemia (AML)
A Phase II Study of Oral Single Agent Panobinostat in Patients With Refractory de Novo or Secondary Acute Myelogenous Leukemia (AML)
This study was to evaluate the efficacy and safety of single agent oral panobinostat in patients who have refractory de novo or refractory secondary AML.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Refractory Leukemia
  • Acute Myelogenous Leukemia
Drug: Panobinostat/LBH589
  • Experimental: 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.
    Intervention: Drug: Panobinostat/LBH589
  • Experimental: 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.
    Intervention: Drug: Panobinostat/LBH589
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
59
February 2012
February 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Written informed consent prior to study-specific screening procedures
  • Life expectancy of ≥ 60 days
  • Eastern Cooperative Group (ECOG) performance status ≤ 2
  • Refractory AML with confirmed initial diagnosis of de novo AML (excluding APL) - OR- Refractory AML with confirmed initial diagnosis of AML (excluding APL) secondary to AHD or MDS with either condition precedent to AML (MDS/AHD)
  • Negative serum pregnancy test (within 7 days of first dose)
  • Negative urine pregnancy test immediately prior to first dose

Exclusion Criteria:

  • Known HIV
  • Psychiatric disorder that interfered with ability to understand the study and give informed consent, and/or would impact study participation or follow-up
  • Concurrent use of medications that might prolong the QT interval or of inducing Torsade de Pointes
  • Female patients who were pregnant or breast-feeding or patients of childbearing potential who were not willing to use a double barrier method of contraception during the study and for 3 months following the last dose of study drug.
  • Male patients whose sexual partner(s) were women of childbearing potential who were not willing to use a double method of contraception, one of which included a condom, during the study and for 3 months after the end of treatment
  • Patient unable to swallow capsules
  • Patients with impaired gastrointestinal systems which might cause interference with digesting and absorbing panobinostat

Other Protocol-defined inclusion/exclusion criteria may apply
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   France,   Germany,   Italy,   Korea, Republic of,   Peru,   Spain,   Switzerland,   Turkey,   United Kingdom,   United States
 
 
NCT00880269
CLBH589B2213
2008-002983-32 ( EudraCT Number )
No
Not Provided
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP