IDH1変異を有する低メチル化剤（HMA）ナイーブ骨髄異形成症候群（MDS）患者におけるイボシデニブ（IVO）単独療法およびアザシチジン（AZA）単独療法

基本情報

NCT ID

NCT06465953

ステータス

募集中

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

48

治験依頼者名

Servier

概要

This study will enroll participants with myelodysplastic syndromes (MDS) with an Isocitrate dehydrogenase protein, 1 (IDH1) mutation, who have not received treatment with a hypomethylating agent previously. Participants will be randomized to receive either ivosidenib (IVO) alone or azacitidine (AZA) alone. IVO will be administered daily throughout the 28-day treatment cycle and AZA will be administered for the first 7 days of each 28-day cycle. Study visits will be conducted every week during Cycle 1 (Days 1, 8, 15, and 22), and Day 1 of each cycle thereafter. After the last dose of treatment, participants will attend an safety follow-up visit and participants will be followed to assess overall survival. Study visits may include a bone marrow aspirate, physical exam, echocardiogram (ECHO), electrocardiogram (ECG), blood and urine analysis, and questionnaires.

対象疾患

介入

依頼者（Sponsor）

実施施設 (5)