新たに診断されたフィラデルフィア染色体陽性（Ph+）慢性骨髄性白血病慢性期（CML-CP）の成人患者におけるイマチニブとニロチニブの比較研究

基本情報

NCT ID

NCT00471497

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

846

治験依頼者名

Novartis

概要

In this study, the efficacy and safety of two nilotinib doses, 300 mg twice daily and 400 mg twice daily, were compared with imatinib 400 mg once daily in newly diagnosed patients with Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP). An extension protocol was included in this study design to allow patients who did not show sufficient response to their assigned treatments the opportunity to receive imatinib 400 mg BID (option available until protocol amendment 7) or nilotinib 400 mg BID, using an abbreviated safety and efficacy assessment schedule.

対象疾患

介入

依頼者（Sponsor）