NCT06368414尚未招募2 期
A Study of Treatment-free Remission in Chronic Phase Chronic Myeloid Leukemia in Combination With Asciminib and Tyrosine Kinase Inhibitors
Korean Society of Hematology0 个研究点目标入组 69 人开始时间: 2024年9月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 69
- 主要终点
- MR3.0 or less by 1 year
研究概览
简要总结
To evaluate the efficacy of asciminib adding on tyrosine-kinase inhibitors (TKI) to achieve treatment-free remission (TFR) in chronic myeloid leukemia (CML) patients in chronic phase who failed prior cessation study of TKI
详细描述
We expect that patients who lost MR3.0 after stopping TKIs, thus failed to maintain treatment-free remission can achieve second sustainable MR4.5 by sustainable MR4.5 for more than 3 years once regained and prolong MRFS by adding asciminib to TKIs. Patients will be restarted on TKIs when they fail sustaining MR3.0 after cessation because restarting TKIs when loss of MR3.0 is reasonable in this situation.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •19 year or older
- •CP-CML patients who are taking current TKIs (imatinib, nilotinib or dasatinib) for 5 years or more
- •Patients who have failed maintaining MR3.0 after 1 or more cessation trial of TKIs.
- •Patients who regained MR3.0 or deeper molecular response by TKIs retrial after TKI cessation failure at the time of screening
- •Taking TKIs over 12 weeks for the retrial of TKIs after TKI cessation failure
- •Patients who agree with stopping asciminib and TKIs after maintaining 23 year-duration of MR4.5
- •Adequate end organ function as defined by:
- •Total bilirubin (TBL) < 3 x upper limit of normal (ULN); patients with Gilbert's syndrome may only be included if TBL ≤ 3.0 x ULN or direct bilirubin ≤ 1.5 x ULN
- •Creatinine clearance (ClCr) ≥ 30 mL/min as calculated using Cockcroft-Gault formula
- •Serum lipase ≤ 1.5 x ULN. For serum lipase > ULN - ≤ 1.5 x ULN, value must be considered not clinically significant and not associated with risk factors for acute pancreatitis
- •Patients who can sign the informed consent of their own free will
排除标准
- •Patients who experienced grade 3 or higher adverse events with TKIs (imatinib, dasatinib, and nilotinib).
- •Patients who are receiving any other investigational agents.
- •Patients who currently have uncontrolled infections
- •Patients who previously received Chimeric antigen receptor T-cell (CAR-T cell) therapy, allogeneic hematopoietic stem cell transplantation (allo-HSCT) or biologic therapy.
- •Patients with clinically significant cardiovascular disease or gastrointestinal dysfunction.
- •Patients who have a history of thromboembolic episodes within 3 months prior to the study enrollment.
- •Patients with active hepatitis B or C with uncontrolled disease activity.
- •Patients who have active malignancies requiring treatment other than CML.
- •Patients with any severe and/or uncontrolled medical conditions or other conditions that could adversely impact on patients' ability to participate in the study.
- •Patients with psychiatric illness/social situations that would limit compliance with study requirements.
- •Pregnant women are excluded from this study Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with asciminib and TKIs, breastfeeding should be discontinued if the mother is treated with asciminib and TKIs.
研究组 & 干预措施
Asciminib arm
Other
干预措施: Asciminib (Drug)
结局指标
主要结局
MR3.0 or less by 1 year
时间窗: by 1 year
To evaluate the cumulative incidence of sustained MR3.0 or less by 1 year of cessation of TKI and asciminib
次要结局
未报告次要终点
研究者
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