JPRN-UMIN000029196已完成2 期
TM5614 IN COMBINATION WITH TYROSINE KINASE INHIBITORS IN CHRONIC PHASE CHRONIC MYELOGENOUS LEUKAEMIA (CP-CML) PATIENTS IN MAJOR MOLECULAR RESPONSE WITHOUT ACHIEVING A DEEP MOLECULAR RESPONSE. - Phase 2 study of TM5614
Tohoku university school of medicine, molecular medicine and therapy0 个研究点目标入组 25 人开始时间: 2017年9月19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
- 25
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
- 18years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
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 (CHF) as determined by the New York Heart Association (NYHA) classification system for heart failure - Myocardial infarction within the previous 6 months - Symptomatic cardiac arrhythmia requiring treatment - QTc above 480msec 5. Known T315I BCR-ABL kinase domain mutation 6. Patients who take Dasatinib within the last 12 weeks 7. Patients who start to take pioglitazone within the last 12 weeks 8. CML patient not in chronic phase at diagnosis 9. Individuals with an active malignancy 10. Known HIV-positivity 11. Individuals with bleeding tendency 12. Other patients whom a lead investigator or the patient's primary physician deems are not appropriate for this study
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