NCT03668392终止2 期
Asparaginase Activity Monitoring (AAM) in Adult Patients With Acute Lymphoblastic Leukemia (ALL)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 7
- 主要终点
- Number of patients with active serum Asparaginase
研究概览
简要总结
In order to understand how pharmacokinetics and immunological inactivation affect the therapeutic efficacy of Asparaginase (ASP), it is of help and advised in the frame of clinical font-line protocols to monitor the enzymatic activity by measuring the serum ASP levels in the days following the administration of the drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent according to ICH/EU/GCP and national local laws
- •Age 18 - 65 years
- •Diagnosis of untreated Ph- ALL entering treatment including PEG-ASP in induction and consolidation
- •ECOG performance status 0-2, unless a performance of 3 is unequivocally caused by the disease itself and not by pre-existing comorbidity, and is considered and/or documented to be reversible following the application of antileukemic therapy and appropriate supportive measures
排除标准
- •Diagnosis of Burkitt's leukemia
- •Down's syndrome
- •Adults with Ph+ ALL
- •Pre-existing, uncontrolled pathology such as heart failure (congestive/ischemic, acute myocardial infarction within the past 3 months, untreatable arrhythmias, NYHA classes III and IV)
- •Severe liver disease with serum bilirubin >3 mg/dL and/or ALT >3 x upper normal limit (unless attributable to ALL)
- •Kidney function impairment with serum creatinine >2 mg/dL (unless attributable to ALL)
- •Severe neuropsychiatric disorder that impairs the patient's ability to understand and sign the informed consent, or to cope with the intended treatment plan
- •Presence of serious, active, uncontrolled infections
- •Pre-existing HIV positive serology (i.e. already known before enrolment). If HIV positivity is detected after enrolment, the patient is put off study.
- •Pregnancy
- •Men and women should use effective contraception during treatment and for at least 6 months after Asparaginase discontinuation. As a precautionary measure, breast-feeding should be discontinued during treatment with Asparaginase and should not be restarted after discontinuation of Asparaginase
研究组 & 干预措施
Patients on Oncospar
Experimental
干预措施: Asparaginase (Drug)
结局指标
主要结局
Number of patients with active serum Asparaginase
时间窗: After 8 months from study entry
次要结局
未报告次要终点
研究者
研究点 (7)
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