FLT3遺伝子変異陰性（FLT3-MN）急性骨髄性白血病（AML）の新規診断患者におけるミドスタウリン＋化学療法の有効性および安全性に関する国際共同研究

基本情報

NCT ID: NCT03512197
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: 511
治験依頼者名: Novartis

概要

The purpose of this study was to confirm the preliminary evidence from early clinical trials that midostaurin may provide clinical benefit not only to AML patients with the FLT3-mutations but also in FLT3-MN (SR\<0.05) AML (FLT3 mutant to wild type signal ratio below the 0.05 clinical cut-off). This study evaluated the efficacy and safety of midostaurin in combination with daunorubicin or idarubicin and cytarabine for induction and intermediate-dose cytarabine for consolidation, and midostaurin single agent post-consolidation therapy in newly diagnosed patients with FLT3-MN (SR\<0.05) AML.

対象疾患

Acute Myeloid Leukemia (AML)

介入

Midostaurin(DRUG)

Placebo(DRUG)

Chemotherapy(DRUG)

依頼者（Sponsor）

ノバルティスファーマ株式会社(INDUSTRY)