EU Clinical Trial 2018-004479-11

A randomized, double-blind, placebo-controlled phase II multi-center study of intravenous MBG453 added to hypomethylating agents in adult subjects with intermediate, high or very high risk myelodysplastic syndrome (MDS) as per IPSS-R criteria  May 30, 2019

Main objective of the trial: - To determine if MBG453 combined with standard HMA therapy improves complete remission in subjects with intermediate, high, or very high risk MDS - To determine if MBG453 combined with standard HMA therapy improves PFS in subjects with intermediate, high or very high risk MDS - Determinar si MBG453 en combinación con la terapia estándar con fármacos hipometilantes (HMA) mejora la remisión completa de los pacientes con riesgo intermedio, alto o muy alto de SMD. - Determinar si MBG453 en combinación con la terapia estándar con HMA mejora la SLPen pacientes con riesgo intermedio, alto o muy alto de SMD.

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AR AT BE CA CZ DE ES FR GB GR HK HU IT JP KR NO SE TR TW US
Keywords
MBG453 Myelodysplastic syndromes Not yet defined

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Source:  EMA Last updated:  Jun 5, 2019

From ClinicalTrialsRegister.eu, a database of the European Medicines Agency. This record may not reflect the most current and accurate data available from the EMA.