A phase III, multi-center, open-label, randomized study of oral asciminib versus Investigator selected TKI in patients with newly diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase -

OVARTIS PHARMA AG0 个研究点目标入组 402 人2021年7月27日

相关药物Sprycel Tasigna Bosulif Glivec

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: 未指定
发起方: OVARTIS PHARMA AG
入组人数: 402
状态: 进行中（未招募）
最后更新: 4年前

概览研究者入排标准结局指标相似试验

概览

简要总结

暂无简介。

注册库

who.int

开始日期

2021年7月27日

结束日期

待定

最后更新

4年前

研究类型

Interventional clinical trial of medicinal product

性别

All

研究者

发起方

OVARTIS PHARMA AG

入排标准

入选标准

•Participants eligible for inclusion in this study must meet all of the following criteria:
•1\. Male or female patients \>\= 18 years of age.
•2\. Patients with CML\-CP within 3 months of diagnosis.
•3\. Diagnosis of CML\-CP with cytogenetic confirmation of Philadelphia chromosome of (9;22\) translocations (presence of BCR\-ABL1 in a review of a minimum 20 metaphases is required).
•\- Documented chronic phase CML will meet all the below criteria Hochhaus et al 2020:
•\< 15% blasts in peripheral blood and bone marrow,
•\< 30% blasts plus promyelocytes in peripheral blood and bone marrow,
•\< 20% basophils in the peripheral blood,
•Platelet count \>\= 100 x 109/L (\>\= 100,000/mm3\),
•No evidence of extramedullary leukemic involvement, with the exception of hepatosplenomegaly.

排除标准

•1\.Previous treatment of CML with any other anticancer agents including chemotherapy and/or biologic agents or prior stem cell transplant, with the exception of hydroxyurea and/or anagrelide. Treatment with imatinib for \<\=2 weeks is allowed, but no other treatment with tyrosine kinase inhibitors prior to study entry is permitted.
•2\.Known cytopathologically confirmed CNS infiltration (in absence of suspicion of CNS involvement, lumbar puncture not required).
•3\.Impaired cardiac function or cardiac repolarization abnormality including but not limited to any one of the following:
•History within 6 months prior to starting study treatment of myocardial infarction (MI), angina pectoris, coronary artery bypass graft (CABG)
•Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high\-grade AV block (e.g., bifascicular block, Mobitz type II and third degree AV block)
•QTc \>\= 450 msec (male patients), \>\=460 msec (female patients) on the average of three serial baseline ECG (using the QTcF formula) as determined by central reading. If QTcF \>\= 450 msec and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re\-screened for QTc.
•Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:
•Risk factors for Torsades de Pointes (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia
•Concomitant medication(s) with a Known risk of Torsades de Pointes per www.crediblemeds.org/ that cannot be discontinued or replaced 7 days prior to starting study drug by safe alternative medication.
•Inability to determine the QTcF interval