JPRN-jRCTs031180332已完成2 期
Phase II Trial of Dasatinib Therapy Aiming for Treatment-Free Remission in Patients with Chronic Phase Chronic Myeloid Leukemia - D-FREE
Yoshida Chikashi0 个研究点目标入组 181 人开始时间: 2019年3月18日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 181
研究概览
简要总结
The study examined whether CML-CP patients (pts) treated with dasatinib (DAS) for <=3 years (yrs) and maintained MR4.5 for exactly 1 year (yr) would achieve TFR if DAS was discontinued. Of the first 21 pts who discontinued, 17 developed molecular relapse. The median duration of treatment with DAS before cessation was 18.9 months, which was shorter than previously reported. These results indicate that maintaining MR4.5 for 1 yr is not sufficient to achieve TFR in CML-CP pts treated with DAS for <= 3 yrs.
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
- •Induction phase
- •1) Patients with newly diagnosed CML-CP
- •2) Patients aged 18 years and over
- •3) Patients with ECOG performance status groups of 0 to 2
- •4) Patients with adequate functions of major organs (liver, kidney, and lung) (according to reference levels of each institution)
- •5) Patients who gave a written informed consent to participation in the trial. Minors who gave a written informed consent or one obtained from their legal representatives
- •Consolidation phase
- •Patients who achieved MR4.5 with dasatinib treatment in the induction phase
- •Patients who sustained MR4.5 for 12 months with dasatinib treatment in the consolidation phase
排除标准
- •1)Active multiple cancers
- •2)Pregnant women and lactating mothers
- •3)Women who do not intend to or cannot use appropriate contraceptives during the registration period
- •4)Patients with a history or complications of the following severe or uncontrollable symptoms
- •-Myocardial infarction within the past 6 months
- •-Angina pectoris within the past 3 months
- •-Gastrointestinal haemorrhage within the past 3 months
- •-Congestive cardiac failure within the past 3 months
- •-Having plural effusion
- •-Electrocardiogram QTc interval prolonged exceeding 450 msec at the start of treatment (baseline) (Fridericia correction)
- •-Present or past history of pulmonary hypertension
- •5)Patients with a history or complications of diseases judged as inappropriate for study implementation by investigators.
研究者
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