Study of LBH589 for Patients With Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
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|ClinicalTrials.gov Identifier: NCT00939159|
Recruitment Status : Terminated (Low Accrual)
First Posted : July 14, 2009
Results First Posted : June 18, 2015
Last Update Posted : June 18, 2015
|Condition or disease||Intervention/treatment||Phase|
|Myelodysplastic Syndrome||Drug: LBH589||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of LBH589 for Patients With Low or Intermediate-1 Risk Myelodysplastic Syndrome|
|Study Start Date :||August 2009|
|Primary Completion Date :||June 2013|
|Study Completion Date :||June 2013|
LBH589 20 mg capsules by mouth 3 times a week for 3 weeks in a 28-day cycle.
20 mg capsules by mouth 3 times a week for 3 weeks in a 28-day cycle.
- Overall Response Rate Based on the Hematologic Improvement [ Time Frame: Assessment with 28-day cycle until response, then every 3 cycles as needed ]
Overall response rate defined by International Working Group (IWG) response criteria in myelodysplasia. Hematologic Improvement (HI) responses, at least 9 weeks: Erythroid response (pretreatment, <11 g/dL): Hgb increase by 1.5 g/dL; Relevant reduction units of Red blood cell (RBC) transfusions by absolute number at least 4 RBC transfusions/8 week compared with pretreatment transfusion number in previous 8 weeks; Only RBC transfusions for Hgb of 9.0 g/dL pretreatment count in RBC transfusion response evaluation; Platelet response (pretreatment,<100x10^9/L): If starting with >20x10^9/L platelets:
absolute increase 30x10^9/L, Increase from baseline <20 x10^9/L to >20x10^9/L and by =/> 100%; Neutrophil response (pretreatment, <1.0x10^9/L): =/> 100% increase & absolute increase >0.5x10^9/L; Progression or relapse after HI: At least 1 of the following: =/>50% decrement from max response levels in granulocytes or platelets; Reduction in Hgb by 1.5 g/dL; or Transfusion dependence .
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): NCT00939159
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Guillermo Garcia-Manero, MD||UT MD Anderson Cancer Center|