NCT05311943招募中3 期
Treatment With Olverembatinib in Chronic Phase Chronic Myeloid Leukemia Patients Who Failed to at Least Two Previously Administered Second-generation Tyrosine Kinase Inhibitors: a Prospective, Single-arm Clinical Trial.
Shenzhen Second People's Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年7月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The proportion of patients who achieve and maintain major molecular response(MMR) at 12 months using RQ-PCR test.
研究概览
简要总结
The purpose of this trial is to evaluate the efficacy and safety of olverembatinib(HQP1351) in patients with chronic myeloid leukemia in chronic phase (CML-CP) who are resistant and/or intolerant to at least two second-generation tyrosine kinase inhibitors. The efficacy of olverembatinib is determined by evaluating the major molecular responses(MMR) at the and of 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years and ≤75 years.
- •Diagnosis of CML-CP.
- •ECOG performance of 0-
- •Adequate end organ function defined as the following: total bilirubin <1.5xULN, SGPT <2.5x ULN, creatinine <1.5x ULN.
- •Resistance and/or intolerance of at least two second-generation TKIs.
- •Patients must sign an informed consent form (ICF) indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital.
排除标准
- •Known to be allergic to study drug ingredients or their analogues.
- •History of undergone major surgery within 4 weeks.
- •Patients unwilling or unable to comply with the protocol.
- •Pregnant or breast-feeding patients.
- •patients with other malignant tumor.
研究组 & 干预措施
olverembatinib
Experimental
40mg, taken orally once every other day of a 28-day cycle
干预措施: olverembatinib (Drug)
结局指标
主要结局
The proportion of patients who achieve and maintain major molecular response(MMR) at 12 months using RQ-PCR test.
时间窗: 12 months
Major molecular response (MMR) is defined as BCR-ABL1 ≤ 0.1 percent.
次要结局
- The proportion of patients with MMR at 3, 6, 9 months.(3, 6, 9 months.)
- Progression free survival (PFS)(12 months)
- Incidence of adverse events (AEs) and serious adverse events (SAEs) to Olverembatinib.(12 months.)
- The proportion of patients with MR 4.0 at 3, 6, 9, 12 months.(3, 6, 9, 12 months.)
- Proportion of patients with MR 4.5 at 3, 6, 9, 12 months.(3, 6, 9, 12 months.)
- Overall survive (OS)(12 months)
研究者
研究点 (1)
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