NL-OMON52067招募中4 期
Patient-guided dose reduction of tyrosine kinase inhibitors in chronic myeloid leukaemia (RODEO): a prospective, multicentre, single-arm study - RODEO
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 140
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
- 18 至 99（—）
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
研究者
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