ACTRN12619000556145招募中1 期
A Phase I study to assess the safety of micro-dose lenalidomide as maintenance therapy post-allogeneic haematopoietic cell transplantation for patients with acute myeloid leukaemia or myelodysplastic syndromes, at high risk of relapse
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 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
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Each patient must have one of the following:
- •a. High risk AML, defined as any of:
- •Not in complete remission (CR) at time of alloHSCT
- •Adverse risk cytogenetics at any stage of disease
- •FLT3-ITD mutation
- •Prior induction failure
- •Evidence of pre-transplant minimal residual disease either by cytogenetics or by flow cytometry. If flow cytometry is the selected method used, MRD must be greater than 0.1%.
- •In second complete remission if duration of first complete remission was less than or equal to 6months.
- •Transformation from myeloid neoplasm at any stage
- •b. High risk MDS, defined as any of:
- •Adverse risk cytogenetics at any stage of disease
- •Over 10% blasts in blood or marrow aspirate pre-transplant
- •AND must meet ALL of the following general inclusion criteria:
- •a.Age 18 years or older.
- •b.No prior exposure to lenalidomide.
- •c. Alkaline phosphatase and transaminases less than or equal to 2 x ULN
- •d. Creatinine clearance greater than or equal to 30 ml/min (calculated by Cockcroft-Gault formula
- •e. Females of childbearing potential must use an effective method of contraception or practice absolute abstinence for 4 weeks prior to lenalidomide therapy, during treatment and 4 weeks after treatment discontinuation
- •f. Male patients must use contraception during lenalidomide treatment and for 1 week after completion of treatment
- •g. ECOG performance status 0-2
- •h. Life expectancy greater than 6 months
- •i. Patient’s written informed consent
- •j. Subjects must agree not to share their medication and return unused supplies
排除标准
- •a. Grade 2-4 aGVHD
- •b. Relapsed or progressive disease on screening bone marrow biopsy
- •c. Active second malignancy currently requiring treatment
- •d. Known hypersensitivity with anaphylactic reaction to lenalidomide
- •e. Class III or IV cardiac disease defined by the NYHA.
- •f. Severe or debilitating pulmonary disease.
- •g. Severe or debilitating central nervous system disease or cerebral dysfunction.
- •h. Active bacterial, viral or fungal infection
- •i. Human Immuno-deficiency Virus (HIV) infection.
- •j.Any coexisting medical or psychological condition that would preclude participation in the required study procedures.
- •k. Female patients who are both lactating and breast-feeding or have a positive serum pregnancy test during the screening period or a positive pregnancy test on Day 1
研究者
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