EUCTR2012-004259-36-ES进行中（未招募）不适用
Multicenter, open-label, non-randomized Phase II trial of dasatinib in patients with Chronic Myeloid Leukemia in Chronic Phase (CP-CML) who meet criteria for late suboptimal response after prior imatinib treatment. - DASAPOST
Fundación PETHEMA0 个研究点开始时间: 2012年11月12日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1Adult patients >or = 18 years
- •2Diagnostic of Ph+ Chronic Myeloid Leukemia in first chronic phase
- •3Treated with Imatinib 400 mg per day or 600 mg per day for at least 18 months. A wash out period of at least 7 days for imatinib is required prior to dasatinib administration
- •4Patients meet criteria of late suboptimal response (complete cytogenetic response with no major molecular response) or have lost major molecular response
- •5Ability to understand and voluntarily sign the informed consent form
- •6Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy and have a negative pregnancy test, a maximum of 72 hours prior to study drug start. Sexually active men must also use effective contraceptive methods during the treatment.
- •7Women must not be breastfeeding.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 65
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 65
排除标准
- •1.Patients treated with Imatinib at a dose different of 400/600 mg per day
- •2.Patients treated with other TKI than imatinib
- •3.Loss of cytogenetic response at study entry
- •4.ECOG ? 3
- •5.Inadequate bone marrow reserve: ANC <1.5 x 109/L and/or Platelet count < 100 x 109/L
- •6.Inadequate hepatic function (Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST)> 2.5 X institutional upper limit of normal (IULN). Total bilirubin > 1.5 X IULN (unless Gilbert syndrome has been diagnosed)
- •7.Inadequate renal function (serum Cr >3 UNL or ClCr <45 ml/min)
- •8.Patients receiving concurrent treatment with other experimental drugs or anti-cancer therapy
- •9.Patients with uncontrolled concurrent disease:
- •a) Known pleural effusion at baseline
- •b) Clinically-significant gastrointestinal disease or surgery that would compromise absorption of study drug (eg, uncontrolled nausea or malabsorption syndrome)
- •c) Clinically-significant known coagulation or platelet function disorder (not related to thrombocytopenia), eg, von Willebrand?s disease
- •d) Other active malignancy requiring concurrent intervention
- •e) Uncontrolled or significant cardiovascular disease, including any of the following:
- •- Myocardial infarction within 6 months of enrolment date
- •- Uncontrolled angina or congestive heart failure within 3 months of enrolment date
- •- Left ventricular ejection fraction (LVEF) < 40%
- •- Significant cardiac conduction abnormality, including history of clinically-significant ventricular arrhythmia (such as ventricular tachycardia, ventricular fibrillation, or Torsades de Pointe), history of third degree heart block or diagnosed congenital long QT syndrome, and/or prolonged QTc/f interval > 450 msec on baseline ECG.
- •10.Patients with active or uncontrolled infections or with serious illnesses or medical conditions that would not permit the patient to be managed according to the protocol.
- •11.Patients unable or unwilling to give written, informed consent prior to study participation.
研究者
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