2024-515409-25-00招募中2 期
Persistence of major molecular remission in chronic myeloid leukemia after a second stop of TKI treatment in patients who failed an initial stop attempt: a multicenter prospective trial. DASTOP2 TRIAL
Region Uppsala4 个研究点 分布在 3 个国家目标入组 32 人开始时间: 2024年9月17日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 4
- 主要终点
- The proportion of patients maintaining MMR at 6 and 12 months after discontinuing TKI a second time (survival without loss of major molecular response, MMR, defined as BCR-ABL1>0.1% on IS at one time point).
研究概览
简要总结
Assessment of treatment-free remission (persistence of MMR) after second attenmpt of TKI discontinuation in patients who failed a relapse in the EURO-SKI study or under EURO-SKI like conditions. Patients must have received at least three years of further TKI treatment of which the two last years should be dasatinib. The patients must have been in MR4 for a least one year.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •CML in CP under TKI treatment after failing a prior attempt to stop treatment within EURO-SKI or outside the study but according to EURO-SKI trial procedures. For the latter group this requires at least 3 years of TKI treatment (first line or second line due to intolerance to first line) before stop, and MR4 for at least one year before stopping
- •Treated with TKI for at least one year after having failed a prior attempt to stop TKI. Previous TKI can be any.
- •Typical BCR/ABL1 transcript (b3a2 and/or b2a2) must have been confirmed at diagnosis or later during the disease course.
- •18 years or older
排除标准
- •Previous hematological relapse after first stop of TKI
- •Pleural or pericardial effusions of any grade at study entry
- •History of significant bleeding disorder unrelated to CML
- •A third stopping attempt
- •Previous AP/BC at any time in the history of the disease
- •Restart of TKI without loss of MMR after first stop
- •Current participation i another clinical study
- •Previous or planned allogeneic stem cell transplantation
- •Patients with contra-indications to dasatinib therapy due to comorbidities
- •Subjects with acute hepatitis B virus HBV) infections
- •Uncontrolled or significant cardiovascular disease
- •Pulmonary arterial hypertension
结局指标
主要结局
The proportion of patients maintaining MMR at 6 and 12 months after discontinuing TKI a second time (survival without loss of major molecular response, MMR, defined as BCR-ABL1>0.1% on IS at one time point).
The proportion of patients maintaining MMR at 6 and 12 months after discontinuing TKI a second time (survival without loss of major molecular response, MMR, defined as BCR-ABL1>0.1% on IS at one time point).
次要结局
- Number of patients who re-achieved stable MR4, and were offered study participation; and overall and progression-free survival and the occurrence of a restart of TKI without prior molecular relapse.
- Clinical and biological factors correlating with persistence of MMR or better after second TKI stop (BCR-ABL level before 2nd stop, Sokal score, gender, duration and type of TKI-treatment, duration of first TKI-stop, immunological biomarkers).
- Time to reachievement of MR4 after second loss of MMR.
- Adverse events related to second TKI stop, clinical and biological factors correlated to development of these AEs.
研究者
Ulla Olsson-Strömberg
Scientific
Region Uppsala
研究点 (4)
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