ACTRN12612000303842已完成1 期
A Strategy of High-Dose Lenalidomide in Combination with Epigenetic Therapies for Relapsed or Refractory Acute Myeloid Leukaemia (AML)- Phase I
Australasian Leukaemia and Lymphoma Group0 个研究点目标入组 20 人开始时间: 2012年3月16日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
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
- Non-randomised 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, 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 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 Performance Status 0-2
- •4.White Cell Count <15 x 10^9/L
- •5.Adequate hepatic function as defined by bilirubin less than or equal to 2 x the upper limit of normal (ULN) and Aspartate transaminase & Alanine transaminase 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
- •8.Females of childbearing potential must use effective methods of contraception or practice absolute abstinence for 4 weeks prior to lenalidomide therapy, during treatment and 4 weeks after treatment discontinuation
- •9.Male patients must use contraception during lenalidomide treatment and for 4 weeks after discontinuation of treatment
- •10.Subjects must agree not to donate blood, semen or sperm while on lenalidomide and for 4 weeks after treatment discontinuation
- •11.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 Ventricle 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 bpm)
- •f.Angina pectoris or acute myocardial infarction (AMI) greater 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.Clinically significant respiratory disease
- •7.Uncontrolled active infection with known HIV or Hepatitis type B or C infection
- •8.Currently active gastrointestinal disease or other disease, that prevents the patient from absorbing or taking oral medication
- •9.Any other concurrent severe and/or uncontrolled medical conditions 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.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 or breastfeeding and the lack of adequate contraception
- •13.Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
研究者
相似试验
撤回
2 期
enalidomide with epigenetic therapy in relapsed or refractory Acute Myeloid Leukaemia (AML)-Phase IIrelapsed and refractory acute myeloid leukaemiaCancer - Leukaemia - Acute leukaemiaACTRN12612000312842Australasian Leukaemia and Lymphoma Group120
招募中
不适用
Consolidation treatment of Lenalidomide for patients with adult T-cell leukemia/lymphoma ineligible for hematopoietic stem cell transplant.JPRN-UMIN000030095orth Japan Hematology Study Group15
已完成
1 期
Evaluation of the Feasible dose of Lenalidomide as maintenance therapy after Allogeneic hematopoietic stem cell Transplantation for multiple myelomamultiple myeloma (including plasma cell leukemia)JPRN-UMIN000010470Division of Hematology, Saitama Medical Center, Jichi Medical University9
进行中（未招募）
不适用
High-dose lanreotide in patients with acromegalyMedDRA version: 14.1Level: PTClassification code 10000599Term: AcromegalySystem Organ Class: 10014698 - Endocrine disordersacromegalyEUCTR2012-005313-39-ITAZIENDA OSPEDALIERA Spedali Civili di Brescia30
进行中（未招募）
不适用
Phase I/II Trial of Lenalidomide in Combination with Vorinostat and Dexamethasone as Therapy in Relapsed or Refractory Patients with Peripheral T-Cell Non-Hodgkin’s Lymphoma (PTCL)EUCTR2008-006919-20-ATArbeitsgemeinschaft medikamentöse Tumortherapie gemeinnützige GmbH