NL-OMON44473已完成4 期
Therapeutic drug monitoring of asparaginase and methotrexate metabolism in childhood acute lymphoblastic leukemia. - Asparaginase and methotrexate in childhood acute lymphoblastic leukemia.
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 2 至 99（—）
入选标准
- •- Patients who are treated according to the DCOG ALL11 protocol.
- •- Informed consent have to be signed by parents/guardians and patient of 12 years or older.
排除标准
- •- Patients who have a contraindication for asparaginase.
- •- Patients with hypersensitivity reactions to PEGasparaginase will switch to Erwinia asparaginase. These patients will be included in the population pharmacokinetic analysis up to the point a hypersensitivity reaction occurs. They will still remain included in the 3 other studies.
- •- Patients who are stratified as high risk will be excluded from the methotrexate study.
研究者
相似试验
已完成
不适用
TDM of Asparaginase in ALL2008Acute Lymphoblastic LeukemiaNCT04843514Aarhus University Hospital765
终止
2 期
Asparaginase Activity Monitoring (AAM) in Adult Patients With Acute Lymphoblastic Leukemia (ALL)Acute Lymphoblastic LeukemiaNCT03668392Gruppo Italiano Malattie EMatologiche dell'Adulto7
进行中（未招募）
1 期
The aim of the study is to monitor the activity of Asparaginase, an enzyme that acts by degrading asparagine, an important component of proteins without which cells can not survive.Normal cells can produce asparagine independently, while some cancer cells are unable to do so. Asparaginase reduces the level of asparagine in the blood cells and stops the growth of cancer cells.Adult patients, aged between 18 and 65, diagnosed with Acute Ph Lymphoblastic Leukemia negative (LAL Ph-) untreated, with a favorable impact on the prognosis.MedDRA version: 21.0Level: LLTClassification code 10060390Term: Leukaemia lymphoblastic acuteSystem Organ Class: 100000004864EUCTR2018-003517-17-ITFONDAZIONE GIMEMA (GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL' ADULTO) FRANCO MANDELLI ONLUS52
尚未招募
1 期
Therapeutic drug monitoring of mycophenolic acid and validation of limited sampling strategies for the estimation area under the mycophenolic acid concentration-time curve in Thai pediatric renal transplant recipients at Siriraj hospitalevel of MPA in pediatric kidney transplantedInfectionTCTR20170206004Faculty of Medicine Siriraj Hospital25
已完成
不适用
Pharmacokinetics of asparaginase in patients with acute lymphoblastic leukemia: prospective observational study.acute lymphoblastic leukemia (ALL)JPRN-UMIN000040630Japan Children's Cancer Study Group(JCCG)110