FMS様チロシンキナーゼ（FLT3）変異を有する再発性または難治性急性骨髄性白血病（AML）患者におけるASP2215と救済化学療法の比較試験

基本情報

NCT ID: NCT02421939
ステータス: 完了
試験のフェーズ: 第3相
試験タイプ: 介入
目標被験者数: 371
治験依頼者名: Astellas Pharma Inc

概要

The purpose of this study was to determine the clinical benefit of ASP2215 therapy in participants with FMS-like tyrosine kinase (FLT3) mutated acute myeloid leukemia (AML) who were refractory to or had relapsed after first-line AML therapy as shown with overall survival (OS) compared to salvage chemotherapy, and determined the efficacy of ASP2215 therapy as assessed by the rate of complete remission and complete remission with partial hematological recovery (CR/CRh) in these participants. This study also determined the overall efficacy in event-free survival (EFS) and complete remission (CR) rate of ASP2215 compared to salvage chemotherapy.

対象疾患

Leukemia, Acute Myeloid (AML)

介入

gilteritinib(DRUG)

LoDAC (Low Dose Cytarabine)(DRUG)

Azacitidine(DRUG)

MEC (Mitoxantrone, Etoposide, Cytarabine)(DRUG)

FLAG-IDA (Granulocyte-Colony Stimulating Factor (G-CSF), Fludarabine, Cytarabine, Idarubicin)(DRUG)

依頼者（Sponsor）

アステラス製薬株式会社(INDUSTRY)