ACTRN12612000312842撤回2 期
A Strategy of High-Dose Lenalidomide in Combination with Epigenetic Therapies for Relapsed or Refractory Acute Myeloid Leukaemia (AML)- Phase II
Australasian Leukaemia and Lymphoma Group0 个研究点目标入组 120 人开始时间: 2012年3月20日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 120
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
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •1. Male or female patients with one of the following diagnoses:
- •a.AML failing previous therapy who are not eligible for transplant or who failed to be salvaged by standard therapy. Patients may be either primary refractory (failure to achieve greater than or equal to 50% blast reduction to 10-25% marrow blasts) or relapsed (greater than or equal to 50% increase in blasts to greater than or equal to 10% bone marrow blasts) after no more than 3 previous lines of chemotherapy, which may include hypomethylating agents
- •b.Myelodysplasia (MDS) transformed to AML with greater than or equal to 20% bone marrow blasts after previous treatment, which may include previous treatment with hypomethylating agents
- •2.Age 18-80 inclusive
- •3.ECOG (Eastern Co-operative Oncology Group) Performance Status 0-2
- •4.White Cell Count (WCC)<15 x 10^9/L (hydroxyurea or thioguanine may be used to reduce the WCC prior to study therapy with a washout period of 24hrs)
- •5.Adequate hepatic function as defined by bilirubin less than or equal to 2 x the upper limit of normal (ULN) and Alanine transaminase (ALT) & aspartate aminotransferase (AST) less than or equal to 3 x ULN
- •6.Adequate renal function as defined by serum creatinine less than or equal to 1.3 ULN
- •7.Serum potassium greater than or equal to 3.8 mmol/L and magnesium greater than or equal to 0.85 mmol/L (electrolyte abnormalities can be corrected with supplementation to meet inclusion criteria)
- •8.All females of childbearing potential (FCBP) must agree to comply with the lenalidomide Pregnancy prevention risk management plan
- •9.Females must agree to abstain from breastfeeding during study participation and for at least 28 days after study drug discontinuation
- •10.All male participants must practice complete abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 28 days following study drug discontinuation, even if he has undergone a successful vasectomy
- •11.Subjects must agree not to donate blood, semen or sperm while on study treatment and for 28 days after treatment discontinuation
- •12.Provision of written informed consent
排除标准
- •1.History of major non-compliance to medication
- •2.Post allogeneic-stem cell transplant patients on immunosuppression therapy greater than or equal to 5mg prednisolone/day or equivalent
- •3.Evidence of central nervous system (CNS) leukaemia
- •4.Impaired cardiac function or clinically significant cardiac disease as follows:
- •a.left ventricular ejection fraction (LVEF) <45% as determined by Multi-gated Acquisition (MUGA) scan or echocardiogram (ECHO)
- •b.Complete left bundle branch block or right bundle branch block + left anterior hemiblock (bifascicular block)
- •c.Obligate use of a cardiac pacemaker
- •d.Congenital long QT syndrome or QTc > 480 msec on the screening electrocardiogram (ECG)
- •e.Clinically significant resting bradycardia (< 50 beats per minute)
- •f.Angina pectoris or acute myocardial infarction (AMI) less than or equal to 3 months prior to starting study drug
- •g.Unstable angina, congestive cardiac failure (CCF) or AMI within the last 6 months
- •5.Patients taking any concurrent medications which have a known risk of prolonging the QTc interval or inducing Torsades de Pointes tachycardia
- •6.Significant respiratory disease
- •7.Uncontrolled active infection with known human immunodeficiency virus (HIV) or Hepatitis type B or C infection
- •8.Currently active gastrointestinal disease (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome, or small bowel resection), or other disease, that prevents the patient from absorbing or taking oral medication
- •9.Any other concurrent severe and/or uncontrolled medical conditions (eg. acute or chronic liver disease, infection, pulmonary disease) that in the opinion of the investigator could potentiate unacceptable safety risks or jeopardise compliance with the protocol
- •10.Previous adverse reaction to the trial drug/s
- •11.Has any other clinically important abnormalities as determined by the investigator that may interfere with his or her participation in or compliance with the study
- •12.Female patients who are pregnant
- •13.Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. This condition must be discussed with the patient prior to signing consent and registration in the trial.
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