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