EUCTR2010-020613-91-DE进行中（未招募）不适用
A randomized, multi-centre, parallel-group, open label, Oncaspar® controlled dose ranging trial of three doses of pegylated recombinant asparaginase in adult patients with newly diagnosed acute lymphoblastic leukaemia - NA
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Previously untreated acute lymphoblastic leukaemia (pro-B, common, pre-B, early T, thymic T, mature T)
- •2. Age >= 18 years and <= 55 years
- •3. Treatment according to GMALL 07/2003 protocol or subsequent GMALL protocols for patients with de novo ALL
- •4. Written informed consent
- •5. Women of child-bearing potential or partner of men with child-bearing potential must use a highly effective method of contraception (pearl index < 1%) such as complete sexual abstinence, combined oral contraceptive, hormone IUCD, vaginal hormone ring, transdermal contraceptive patch, contraceptive implant or depot contraceptive injection in combination with a second method of contraception like a condom or a cervical cap / diaphragm with spermicide or surgical sterilisation (vasectomy) in male patients or male partners during the study and at least 6 months thereafter
- •6. Negative pregnancy test for women of child-bearing potential
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 56
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patients with Philadelphia chromosome / Bcr-Abl positive ALL
- •2. Severe comorbidity or leukaemia-associated complications
- •3. Known hypersensitivity to asparaginase
- •4. History of severe pancreatitis
- •5. History of thrombosis or pulmonary embolism
- •6. Pre-existing clinically relevant coagulopathy
- •7. Liver dysfunction (e.g. acute or current hepatitis, alcohol or drug abuse) or history of clinically relevant liver disease
- •8. Bilirubin > 1.5 x ULN
- •9. Other current malignancies
- •10. Severe psychiatric illness or other circumstances which may compromise the cooperation of the patient or the ability to give informed consent
- •11. Body mass index > 30 kg/m²
- •12. Known pregnancy, breast feeding
研究者
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