IDH1変異を有する未治療の急性骨髄性白血病患者を対象とした、アザシチジンとの併用におけるAG-120（イボシデニブ）とプラセボの比較試験

基本情報

NCT ID: NCT03173248
ステータス: 実施中（募集終了）
試験のフェーズ: 第3相
試験タイプ: 介入
目標被験者数: 146
治験依頼者名: Servier

概要

Study AG120-C-009 is a global, Phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial to evaluate the efficacy and safety of AG-120 (ivosidenib) + azacitidine vs placebo + azacitidine in adult participants with previously untreated IDH1m AML who are considered appropriate candidates for non-intensive therapy. The primary endpoint is event-free survival (EFS). The key secondary efficacy endpoints are overall survival (OS), rate of complete remission (CR), rate of CR and complete remission with partial hematologic recovery (CRh), and overall response rate (ORR). Participants eligible for study treatment based on Screening assessments will be randomized 1:1 to receive oral AG-120 or matched placebo, both administered in combination with subcutaneous (SC) or intravenous (IV) azacitidine. An estimated 200 participants will take part in the study.

対象疾患

Newly Diagnosed Acute Myeloid Leukemia (AML)Untreated AMLAML Arising From Myelodysplastic Syndrome (MDS)Leukemia, Myeloid, Acute

介入

AG-120(DRUG)

Placebo(DRUG)

Azacitidine(DRUG)

依頼者（Sponsor）

Institut De Recherches Internationales Servier(OTHER)

実施施設 (4)

福井大学医学部附属病院

Fukui, Japan

姫路赤十字病院

Himeji, Japan

神戸市立医療センター中央市民病院

Kobe, Japan

松山赤十字病院

Matsuyama, Ehime, Japan