EUCTR2008-004106-13-FI进行中（未招募）不适用
An Open-Label, Randomized, Multicenter Phase II Trial Comparing the Depletion of Malignant Stem Cells with Dasatinib vs. Imatinib in Patients with Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia
niversity of Trondheim, NTNU, Norway0 个研究点目标入组 40 人开始时间: 2008年12月11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
- 入组人数
- 40
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
- •1.Patients are able to provide written informed consent
- •2.Patients must have CML in CP as defined in the protocol
- •3.Patients must be enrolled in this study within 90 days after the date of first being diagnosed with CML
- •4.ECOG Performance Status (PS) Score 0 - 1 (see Appendix 2)
- •5.Adequate hepatic function defined as: total bilirubin = 2.0 times the institutional upper limit of normal (ULN) in absence of Gilbert type unconjugated hyperbilirubinemia; alanine aminotransferase (ALAT) = 2.5 times the institutional ULN.
- •6.Adequate renal function defined as serum creatinine = 2 times the institutional ULN.
- •7.Men and women, ages 18 years and older.
- •8.Adequate BM aspiration sample before the start of study treatment (i.e sample is sufficient for stem cell analysis)
- •9.Potentially fertile women must use an adequate method of contraception to avoid pregnancy throughout the study.
- •10.Potentially fertile women must have a negative serum or urine pregnancy test
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Fertile women who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study
- •2.Women who are pregnant or breastfeeding.
- •3.Men with fertile sexual partners who can or will not use an acceptable contraception method for the entire study
- •4.A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy.
- •5.Known pleural effusion at baseline.
- •6.Uncontrolled or significant cardiovascular disease, including any of the following:
- •A myocardial infarction within 6 months
- •Uncontrolled angina within 3 months
- •Congestive heart failure within 3 months
- •Diagnosed or suspected congenital long QT syndrome
- •Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de Pointe)
- •Prolonged QTcF interval > 450 msec on pre-entry ECG
- •7.History of significant bleeding disorder unrelated to CML, including:
- •Diagnosed congenital bleeding disorders (e.g., von Willebrand’s disease)
- •Diagnosed acquired bleeding disorder within one year (e.g., acquired antifactor VIII antibodies).
- •8.Prior chemotherapy for peripheral stem cell mobilization. (Prior collection of unmobilized peripheral blood stem cells is permitted).
- •9.Inadequate BM aspiration sample due to marrow fibrosis or other reasons
- •10.Prior or concurrent malignancy, except for the following:
- •adequately treated basal cell or squamous cell skin cancer
- •cervical carcinoma in situ
- •adequately treated Stage I or II cancer from which the subject is currently in complete remission
- •any other cancer from which the subject has been disease-free for three years.
- •11.Severe psychiatric illness, imprisonment or mental impairment inflicting on ability to give informed consent
- •12.Abuse of alcohol, prescribed or illicit drugs
- •13.Evidence of digestive dysfunction that would prevent administration of study therapy by mouth.
- •14.Prohibited Treatments and/or Therapies
- •Any prior treatment with interferon
- •Any prior treatment with dasatinib
- •Any prior treatment with imatinib
- •Any other prior systemic treatments, with anti-CML activity [except for anagrelide, or hydroxyurea (HU)].
- •15. Patients currently taking drugs that are generally accepted to have a risk of causing Torsades de Pointes as described in Appendix 3. Patients who have discontinued any of these medications must have a wash-out period of at least 5 days or at least 5 half-lives of the drug (whichever is greater) prior to the first dose of study therapy. Amiodarone must be discontinued for at least 14 days prior to randomization.
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