Efficacy and Safety of Panobinostat (LBH589) in Patients With Refractory de Novo or Secondary Acute Myelogenous Leukemia (AML)
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|ClinicalTrials.gov Identifier: NCT00880269|
Recruitment Status : Completed
First Posted : April 13, 2009
Results First Posted : September 9, 2016
Last Update Posted : February 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Refractory Leukemia Acute Myelogenous Leukemia||Drug: Panobinostat/LBH589||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||59 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Oral Single Agent Panobinostat in Patients With Refractory de Novo or Secondary Acute Myelogenous Leukemia (AML)|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||February 2012|
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.
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.
- 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.
- 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 learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00880269
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|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|