EUCTR2006-003180-31-NL进行中（未招募）不适用
Comparative efficacy and safety of two asparaginase preparations in children with previously untreated acute lymphoblastic leukaemia - Comparative efficacy and safety of two asparaginase preparations in children with de novo A
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- medac GmbH
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
- •- Previously untreated T-lineage or precursor B-lineage ALL
- •- Patients must have morphological proof of ALL and diagnosis must be
- •made from bone marrow morphology with ? 25% blasts
- •- Age 1 year to 18 years
- •- Written informed consent
- •- Treatment according to DCOG ALL 10 protocol
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Mature B-lineage ALL
- •- Patients with secondary ALL
- •- Known allergy to any ASNase preparation
- •- General health status according to Karnofsky / Lansky score < 40%
- •- Pre-existing known coagulopathy (e.g. haemophilia)
- •- Pre-existing pancreatitis
- •- Liver insufficiency (Bilirubin > 50 µmol/L; SGOT/SGPT > 10 x ULN)
- •- Other current malignancies
- •- Pregnancy (planned or existent), breast feeding
研究者
相似试验
已完成
3 期
Comparative efficacy and safety of two asparaginase preparations in children with previously untreated acute lymphoblastic leukemia (ALL), a phase III clinical trialacute lymphoblastic leukemia in children10024324NL-OMON33823Medac198
已完成
3 期
Comparative Efficacy and Safety of Two Asparaginase Preparations in Children With Previously Untreated Acute Lymphoblastic LeukaemiaAcute Lymphoblastic LeukemiaNCT00784017medac GmbH199
已完成
不适用
Comparison of efficacy and safety of two natural surfactants, Curosurf and Survanta in treatment of neonatal respiratory distress syndromeRespiratory distress syndrome.Respiratory distress syndrome of newbornIRCT2015071017413N12Baqiyatallah University of Medical Sciences, Deputy of Research112
已完成
不适用
Efficacy and safety of prolonged use of aspirin or rivaroxaban after surgery for hip fracturesPrevention of venous thromboembolism after hip fracture surgeryCirculatory SystemISRCTN76129839Department of Orthopedic Surgery, West China Hospital, Sichuan University390
尚未招募
2 期
The effect of anesthetic gel (lidocaine and benzocaine) in reducing injection pain in childreIRCT20240616062152N1Islamic Azad University24