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Brief Title: LBH589 Alone or in Combination With Erythropoietin Stimulating Agents (ESA) in Patients With Low or Int-1 Risk Myelodysplastic Syndromes (MDS)
Official Title: 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
Study ID: NCT01034657
Brief Summary: 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Novartis Investigative Site, Mannheim, Baden-Württemberg, Germany
Novartis Investigative Site, Berlin, , Germany
Novartis Investigative Site, Bonn, , Germany
Novartis Investigative Site, Dresden, , Germany
Novartis Investigative Site, Duesseldorf, , Germany
Novartis Investigative Site, Duisburg, , Germany
Novartis Investigative Site, Frankfurt, , Germany
Novartis Investigative Site, Goettingen, , Germany
Novartis Investigative Site, Hannover, , Germany
Novartis Investigative Site, Leipzig, , Germany
Novartis Investigative Site, Muenchen, , Germany
Novartis Investigative Site, Ulm, , Germany
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR