2種類以上のTKIによる治療を受けたCML-CP患者に対するABL001とボスチニブの有効性の比較試験

基本情報

NCT ID

NCT03106779

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

233

治験依頼者名

Novartis

概要

The purpose of this pivotal study was to compare the efficacy of asciminib (ABL001) with that of bosutinib in the treatment of patients with CML-CP having previously been treated with a minimum of two prior ATP-binding site TKIs. Patients intolerant to the most recent TKI therapy must have had BCR-ABL1 ratio \> 0.1% IS at screening and patients failing their most recent TKI therapy must have met the definition of treatment failure as per the 2013 European LeukemiaNet (ELN) recommendations. Patients with documented treatment failure as per 2013 ELN recommendations while on bosutinib treatment had the option to switch to asciminib treatment within 96 weeks after the last patient has been randomized on study.

対象疾患

介入

依頼者（Sponsor）