NCT00422890已完成3 期
Treatment of Imminent Haematological Relapse in Patients With AML and MDS Following Allogeneic Stem Cell Transplantation With 5-azacitidine (Vidaza®)
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Efficacy of 5-Azacytidin in the treatment of the haematological relapse in patients suffering from acute myeloid leukaemia or myelodysplastic syndrome with falling CD34-chimerism after hematopoietic stem cell transplantation.
研究概览
简要总结
Efficacy and safety of 5-Azacytidin in the treatment of the haematological relapse in patients suffering from acute myeloid leukaemia or myelodysplastic syndrome with falling CD34-chimerism after hematopoietic stem cell transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Screening phase:
- •Age > 18 years
- •Patients with CD34+ AML or MDS post-allogeneic HSCT
- •Written patient consent after consultation
- •Treatment phase
- •AML/MDS: donor chimerism < 80% in the CD34+ subpopulation following allogeneic HSCT in patients with CD34+ AML or MDS, but with no haematological relapse (blasts < 5% in bone marrow)
- •Leukocytes > 3 Gpt/l and platelets > 75 Gpt/l (transfusion-independent)
排除标准
- •Known intolerance to 5-azacitidine or mannitol
- •Uncontrollable infectious disease
- •Patients with active hepatitis B or C or HIV infection
- •Severe hepatic function impairment (ASAT and ALAT may not be above three times the normal value) or hepatic cirrhosis, or malignant hepatic tumour
- •Renal function impairment (creatinine > twice the normal value, creatinine clearance < 50 ml/min)
- •Pregnancy or lactation
- •Women of childbearing age, except for those who meet the following criteria:
- •postmenopausal (12 months natural amenorrhoea)
- •postoperative (6 weeks after bilateral ovarectomy with or without hysterectomy)
- •regular and correct use of a contraceptive method with an error rate < 1% per year (e.g. implants, depot injections, combined oral contraceptives, intrauterine device - IUD, whereby hormonal coils with a Pearl Index of < 1% are safer than copper coils)
- •sexual abstinence
- •Partner vasectomy
- •Men who do not use one of the following for contraception:
- •sexual abstinence
- •post vasectomy
- •Participation of the patient in a drug trial outside the indication of allogeneic transplantation up to four weeks before study initiation
- •Addictive or other illnesses that prevent the person concerned from comprehending the nature and impact, as well as potentical consequences of the clinical trial
- •Evidence that the patient may intentionally not comply with the protocol, e.g. lack of cooperation With the exception of a known allergic reaction or intolerance to 5-azacitidine, these criteria do not apply to the screening phase.
结局指标
主要结局
Efficacy of 5-Azacytidin in the treatment of the haematological relapse in patients suffering from acute myeloid leukaemia or myelodysplastic syndrome with falling CD34-chimerism after hematopoietic stem cell transplantation.
时间窗: 4 months
次要结局
- Safety of 5-Azacytidin in the treatment of the haematological relapse in patients suffering from acute myeloid leukaemia or myelodysplastic syndrome with falling CD34-chimerism after hematopoietic stem cell transplantation.(4 months)
研究者
研究点 (2)
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