JPRN-jRCTs071230047招募中2 期
ASciminib for SEcond attempt Treatment-free remission in patients with CML-CP - ASSET-CM
Kimura Shinya0 个研究点目标入组 90 人开始时间: 2023年7月27日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Pre-Registration Inclusion Criteria
- •Patients with Chronic Myelogenous Leukemia-Chronic Phase(CML-CP) who satisfy all of the following criteria.
- •(1) Patients without extramedullary leukemia, except for hepatomegaly and splenomegaly mass.
- •(2) Patients with molecular genetic relapse (MMR loss: BCR-ABL1 mRNA IS > 0.1% by RQ-PCR) despite discontinuation of Tyrosine Kinase Inhibitor(TKI) after achieving DMR (MR4.0 or MR4.5: BCR-ABL1 mRNA IS =<0.01% or =<0.0032% by RQ-PCR) of at least 1 year with 1st line or 2nd line or later TKI treatment.*1
- •*1) In principle, molecular relapse (loss of MMR) is the standard, but patients who restarted treatment due to loss of DMR at the discretion of a doctor are also included.
- •(3) Patients who have any of the following categories after criteria (2) above.
- •1) Patients who were treated with asciminib as the 3rd line or later, after resistance/intolerance to 2nd line or later TKI treatment.
- •2) Patients who were on TKI up to the 2nd line at criteria (2) above, and who were treated with asciminib as a 3rd line or later treatment at the discretion of the attending physician.
- •(4) Patients with DMR (MR4.5: BCR-ABL1 mRNA IS =<0.0032% by RQ-PCR) after criteria (3) above.
- •(5) Patients 18 years or older at pre-registration.
- •(6) Patients with ECOG PS score of 0-2.
- •(7) Patients who are judged by the investigator or sub-investigator that the functions of major organs (liver, kidneys and lungs) are maintained.
- •(8) Patients with written consent.
- •2. Official Registration Inclusion Criteria
- •(1) Patients who confirmed two consecutive DMR (MR4.5).
- •(2) Patients whose written consent was already obtained at pre-registration.
排除标准
- •Patients who fall under any of the following criteria will not be selected as the subjects of this study.
- •(1) Patients with active double cancer.
- •(2) Patients who are in pregnancy or under breast feeding.
- •(3) Patients with a history of hypersensitivity to asciminib hydrochloride.
- •(4) Patients with a history of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis.
- •(5) Patients who are deemed to be ineligible for the study by the investigator or sub-investigator.
研究者
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