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Effectiveness and safety of gilteritinib (ASP2215) as maintenance treatment (maintain the response achieved during the first course of treatment) for Acute myeloid leukemia patients who are in a firs...

Mise à jour : Il y a 4 ans
Référence : EUCTR2016-001643-39

Effectiveness and safety of gilteritinib (ASP2215) as maintenance treatment (maintain the response achieved during the first course of treatment) for Acute myeloid leukemia patients who are in a first complete remission (no residual leukemia cells in your bone marrow), with mutations in the FLT3 gene compared to placebo given alone. Fenntartó kezelésként alkalmazott gilteritinib (ASP2215) hatásosságának és biztonságosságának vizsgálata első teljes remisszió időszakában levő (tumorsejt nem található a csontvelőben), FLT3 génmutációval rendelkező, akut myeloid leukémiában szenvedő betegek körében, placebóhoz viszonyítva

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Extrait

The primary objective is to compare relapse-free survival (RFS) between subjects with FLT3/ITD AML in first complete remission (CR1) without transplant and who are randomized to receive gilteritinib or placebo beginning after completion of induction/consolidation chemotherapy for a 2-year period.

Critère d'inclusion

  • Subjects diagnosed with FLT3/ITD acute myeloid leukemia (AML) in CR1, including CRp and CRi, for whom a decision not to proceed with transplantation has been made, or a suitable donor could not be identified

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