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A Study Evaluating Venetoclax in Combination with Azacitidine Compared with Azacitidine Alone in Subjects with Previously Untreated Higher-Risk Myelodysplastic Syndromes (MDS)

Update Il y a 4 ans
Reference: EUCTR2016-001657-41

Woman and Man

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Extract

The primary objectives of the study are to: • Assess the safety profile and pharmacokinetics (PK) of venetoclax in combination with azacitidine • Determine the recommended dose (RD) and dosing schedule of venetoclax in combination with azacitidine • Determine the overall response rate of venetoclax in combination with azacitidine and of azacitidine monotherapy

Inclusion criteria

  • Treatment-Naïve Higher-Risk Myelodysplastic Syndromes (MDS)

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