2024-516511-24-00招募中4 期
A Patient guided dose reduction strategy of tyrosine kinase inhibitors in chronic myeloid leukaemia: RODEO study
Stichting Radboud universitair medisch centrum9 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2024年9月26日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 136
- 试验地点
- 9
- 主要终点
- The primary study outcome is the proportion of patients with treatment failure at 12 months after first dose reduction.
研究概览
简要总结
The primary objective of this study is to assess the proportion of patients with treatment failure at 12 months after first dose reduction, defined as patients who have restarted their initial dose due to (expected) loss of MMR.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Aged ≥ 18 years -Diagnosed with chronic phase CML - treated with a TKI (imatinib, bosutinib, dasatinib, nilotinib, ponatinib, there are no restrictions regarding using a lower than standard dose at inclusion, or previously having switched from TKI due to toxicity - major molecular response (MMR) or better for an uninterrupted period of at least 6 months at inclusion date - Able and willing to participate - Has provided written informed consent
排除标准
- •Inability to understand the nature and extent of the trial and the procedures required (left at the discretion of the treating physician) - Previous loss of MMR on a reduced TKI dose due to intolerability - Molecular or cytogenetic failure to previous TKI - Previous allogeneic hematopoietic stem cell transplantation - CML in accelerated phase or blast crisis - Pregnancy or lactation - Life expectancy ≤ 1 year
结局指标
主要结局
The primary study outcome is the proportion of patients with treatment failure at 12 months after first dose reduction.
The primary study outcome is the proportion of patients with treatment failure at 12 months after first dose reduction.
次要结局
未报告次要终点
研究者
Nicole Blijlevens
Scientific
Stichting Radboud universitair medisch centrum
研究点 (9)
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