LBH589 Alone or in Combination With Erythropoietin Stimulating Agents (ESA) in Patients With Low or Int-1 Risk Myelodysplastic Syndromes (MDS)

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

This study assessed the efficacy and safety of LBH589 as single agent and 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 study had a non-randomized core phase followed by a randomized phase.

Key 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

Key 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