ISRCTN40571019已完成2 期
eukaemia Lymphoma Research and NCRI Working Group Pick a Winner Programme (LI-1) Trial Trial: Multicentre phase II/III interventional study
Cardiff University (UK)0 个研究点目标入组 243 人开始时间: 2011年3月14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
- 243
研究概览
简要总结
2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33961292/ Results for combination of low-dose ara-C plus tosedostat versus low-dose ara-C alone (added 10/05/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34597366/ Results for combination of low-dose ara-C plus quizartinib versus low-dose ara-C alone (added 04/10/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Patients have one of the forms of acute myeloid leukaemia, except Acute Promyelocytic Leukaemia as defined by the WHO Classification (Appendix A) this can be any type of de novo or secondary AML ? or high risk Myelodysplastic Syndrome, defined as greater than 10% marrow blasts (RAEB-2)
- •2. Normally over the age of 60, but patients under this age are eligible if they are not considered fit for the NCRI AML16 trial or any subsequent equivalent trial
- •3. Written informed consent
- •4. For the AC220 interventions cardiac criteria must be met. Electrolyte levels of potassium, magnesium and calcium must be within the institutional normal range
排除标准
- •1. Patients have previously received cytotoxic chemotherapy for AML. (Hydroxycarbamide or similar low-dose therapy, to control the white count is not an exclusion criterion)
- •2. For AC220 treatment the following criteria make a patient ineligible for that randomisation:
- •2.1. A myocardial infarction within 12 months
- •2.2. Uncontrolled angina within 6 months
- •2.3. Current or history of congestive heart failure New York Heart Association (NYHA) class 3 or 4, unless an echocardiogram (ECHO) or multiple gated acquisition scan (MUGA) performed either within 1 month prior to study screening or during screening results in a left ventricular ejection fraction (LVEF) that is = 45% (or institutional lower limit of normal value)
- •2.4. Diagnosed or suspected congenital long QT syndrome. Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, torsades de pointes [TdP]) or any history of arrhythmia will be discussed with the clinical coordinator/safety physician prior to patient?s entry into the study
- •2.5. Prolonged QTcF interval on pre-entry ECG (=450 ms)
- •2.6. Any history of second or third degree heart block (may be eligible if the patient currently has a pacemaker
- •2.7. Heart rate < 50/minute on pre-entry ECG
- •2.8. Uncontrolled hypertension
- •2.9. Obligate need for a cardiac pacemaker
- •2.10. Complete left bundle branch block
- •2.11. Atrial fibrillation
- •3. In blast transformation of chronic myeloid leukaemia (CML)
- •4. Concurrent active malignancy under treatment
- •5. Pregnant or lactating
- •6. Acute Promyelocytic Leukaemia
- •7. Known infection with human immunodeficiency virus (HIV)
研究者
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