ACTRN12607000609459已完成2 期
A Phase II Study of Dasatinib Combined with Induction Chemotherapy in Previously Untreated de novo Philadelphia Chromosome-Positive Acute Lymphoblastic Leukaemia to Assess Safety and Tolerability
Australasian Leukaemia and Lymphoma Group (ALLG)0 个研究点目标入组 20 人开始时间: 2007年11月28日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 16 Years 至 70 Years（—）
- 性别
- All
入选标准
- •1.Patients aged between 16 and 70 years (inclusive)
- •2.Patients with a confirmed diagnosis of Ph+ ALL
- •3.Female patients of childbearing potential must have a negative pregnancy test, conducted within 7 days prior to registration.
- •4.Patient has given written informed consent.
- •5.Previously untreated with antineoplastic therapy for Ph+ A
排除标准
- •1.Exposure to any other investigational agents within 30 days of registration.
- •2.Known sensitivity to dasatinib
- •3.Eastern Cooperative Oncology Group (ECOG) performance status score > 2
- •4.Left ventricular ejection fraction < 50%
- •5.Creatinine >/= 1.5 x the upper limit of normal (ULN)
- •6.Serum bilirubin >/= 2 x ULN
- •7.AST or ALT > 2.5 x ULN
- •8.Known HIV or hepatitis B seropositivity
- •9.Pregnancy or breastfeeding
- •10. Prior diagnosis or evidence of chronic myeloid leukaemia (CML)
研究者
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