Trial Information
A One Year, Open Label, Multicenter Trial of LBH589 Alone or in Combination With ESA in Red Blood Cell Transfusion-dependent LOW and INT-1 MDS Patients Being Either Refractory to ESA or With a Low Probability of Response - the GErman PAnobinostat Low Risk MDS Trial - GEPARD Study
Inclusion Criteria:
- Patients with a lower risk MDS (LOW or INT-1 according to IPSS)
- Red blood cell transfusion dependency of at least 4 Units/8 weeks.
- Not responding to Erythropoietin stimulating agents (ESA) or having a low chance to
do so
- Age-adjusted normal cardiac, kidney, liver function
Exclusion Criteria:
- Concomitant use of ESA
- Concomitant use of any other investigational drug
- Other malignancy that is not in remission for at least 1 year
- Platelet Count < 75 x 109/L
- Impaired cardiac function or clinically significant cardiac diseases
Other protocol-defined inclusion/exclusion criteria may apply
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Evaluation of the hematological improvement of the erythropoietic system (HI-E) using modified IWG criteria (Cheson 2006) in patients treated with LBH589 single agent
Outcome Time Frame:
16 weeks
Safety Issue:
No
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
CLBH589BDE04
NCT ID:
NCT01034657
Start Date:
November 2009
Completion Date:
Related Keywords:
- Myelodysplastic Syndrome (MDS)
- MDS
- bone marrow
- anemia
- cytopenia
- transfusion dependance
- EPO
- ESA
- erythropoietin
- LBH589
- Myelodysplastic Syndromes
- hematopoietic improvement
- IPSS Low
- IPSS Int-1
- HI-E
- HDAC Inhibitor
- HDAC-I
- DAC-I
- Deacetylase-Inhibitor
- Histondeacetylase-Inhibitor
- red blood cell transfusions
- Myelodysplastic Syndromes
- Preleukemia