A Phase 2/3 Multicenter, Open-label, 3-arm, 2-stage Randomized Study of ASP2215 (Gilteritinib), Combination of ASP2215 Plus Azacitidine and Azacitidine Alone in the Treatment of Newly Diagnosed Acute ...

Mise à jour : Il y a 4 ans
Référence : EUCTR2015-001790-41

A Phase 2/3 Multicenter, Open-label, 3-arm, 2-stage Randomized Study of ASP2215 (Gilteritinib), Combination of ASP2215 Plus Azacitidine and Azacitidine Alone in the Treatment of Newly Diagnosed Acute Myeloid Leukemia with FLT3 Mutation in Patients Not Eligible for Intensive Induction Chemotherapy

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Extrait

Determine the efficacy superiority of ASP2215 and/or ASP2215 plus azacitidine versus azacitidine as measured by overall survival (OS).


Critère d'inclusion

  • Newly Diagnosed Acute Myeloid Leukemia with FLT3 Mutation in Patients Not Eligible for Intensive Induction Chemotherapy