JPRN-jRCT2031190071进行中（未招募）2 期
Phase 2, Open-label, Long-term study of the safety and efficacy of TM5614 in combination with tyrosine kinase inhibitors in chronic phase chronic myelogenous leukemia patients
Harigae Hideo0 个研究点目标入组 35 人开始时间: 2019年8月8日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 35
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) Patient aged 18y or older
- •(2) Signed informed consent
- •(3) Patient with Philadelphia chromosome positive chronic phase CML and Major BCR-ABL1 transcript positivity
- •(4) Treatment with imatinib, nilotinib, dasatinib or bosutinib for more than 1 years overall
- •(5) No switch between TKIs within the last 12 weeks
- •(6) No dose modification of TKI within the last 12 weeks
- •(7) BCR-ABL(IS) <= 0.1%
- •(8) BCR-ABL(IS) > 0.0032%
- •(9) ECOG PS grade 0 to 2
- •(10) AST and ALT <= 2.5 times the upper limit of the reference value
- •(11) Bilirubin in serum <= 2.5 times the upper limit of the reference value
- •(12) Men and Women of childbearing potential must be using an adequate method of contraception
排除标准
- •(1) Pregnant or lactating women
- •(2) Participation in another clinical trial with any investigative drug within 30 days prior to study enrolment,
- •(3) Prior history of hematopoietic stem cell transplantation (autologous or allogenic)
- •(4) Cardiovascular disease:
- •- Stage II to IV congestive heart failure as determined by the NYHA classification system for heart failure
- •- Myocardial infarction within the previous 6 months
- •- Symptomatic arrhythmias that need treatment
- •(5) Known T315I BCR-ABL kinase domain mutation
- •(6) CML patient not in chronic phase at diagnosis
- •(7) Patients with an active malignancy
- •(8) Known HIV-positivity
- •(9) Patients with bleeding tendency
- •(10) Other patients whom a lead investigator or the patient's primary physician deems are not appropriate for this study
研究者
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