EUCTR2011-005989-38-DK进行中（未招募）1 期
A SAFETY AND EFFICACY STUDY OF ADDING LOW DOSE PEGYLATED IFN-?LPHA 2B TO STANDARD DOSE DASATINIB IN PATIENTS WITH NEWLY DIAGNOSED CHRONIC PHASE CHRONIC MYELOID LEUKEMIA - NordCML007
orwegian University of Science and Technology0 个研究点目标入组 35 人开始时间: 2013年11月19日最近更新:
相关药物
试验速览
- 阶段
- 1 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 clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Inclusion Criteria:
- •1.Age =18- 70 years of age
- •2.Diagnosis of chronic myeloid leukemia in chronic phase (CML-CP) associated with BCR-ABL1 quantifiable by RQ-PCR (IS)
- •3.No other current or planned anti-leukemia therapies excluding hydroxyurea treatment for up to two months.
- •4.ECOG Performance status 0,1, or 2
- •5.Adequate organ function as defined by: Total bilirubin < 1.5 x ULN (ULN = upper limit of normal in a local institution lab) in absence of Gilbert genotype; ASAT and ALAT < 2.5 x ULN. Creatinine < 2x ULN. Potassium, magnesium and phosphate not below LLN (LLN= lower level of normal)
- •6.Life expectancy of more than 12 months in the absence of any intervention
- •7.Patient has given written informed consent to participate in the study
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1.Prior accelerated phase or blast crisis
- •2.Uncontrolled or significant cardiovascular disease, including any of the following:
- •a.A myocardial infarction within 6 months
- •b.Uncontrolled angina within 3 months
- •c.Congestive heart failure within 3 months
- •d.Diagnosed or suspected congenital long QT syndrome
- •e.Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de Pointe)
- •f.Prolonged QTcF interval > 450 msec on pre-entry ECG
- •3.Atypical BCR-ABL1 transcript not quantifiable by RQ-PCR.
- •4.Another primary malignant disease, which requires systemic treatment (chemotherapy or radiation)
- •5.Severe and/or life-threatening medical disease including acute liver disease
- •6.History of significant congenital or acquired bleeding disorder unrelated to cancer
- •7.Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of dasatinib
- •8.Patients actively receiving therapy with strong CYP3A4 inhibitors and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug
- •9.Patients who are currently receiving treatment with any medications that have the potential to prolong the QT interval and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug
- •10.Female patients who are: pregnant, breast feeding or potentially fertile without a negative pregnancy test prior to baseline or unwilling to use contraception on trial
- •11.History of non-compliance, abuse of alcohol, illicit drugs, severe psychiatric disorders or other inability to grant informed consent.
- •12.Hypersensitivity to any interferon preparation;
- •13.Autoimmune hepatitis or a history of autoimmune disease;
- •14.Pre-existing thyroid disease unless it can be controlled with conventional treatment;
- •15.Epilepsy and/or compromised central nervous system (CNS) function;
- •16.HCV/HIV patients
- •17. Depression requiring treatment
- •18. Known or suspected hypersensitivity to dasatinib or any of its excipients
- •19. Patients with rare hereditary problems of fructose intolerance, glucose galactose malabsorption or sucraseisomaltase insufficiency
研究者
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