NCT04954326已完成2 期
A Multicentre, Phase II Randomized Study, Open-label, With 2-arm Parallel Group, Comparing the Pharmacokinetics of the Liquid and the Lyophilized Formulations of Pegaspargase (S95014) in Treatment of Paediatric Patients With Newly-Diagnosed 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
- 已完成
- 入组人数
- 89
- 试验地点
- 5
- 主要终点
- Pharmacokinetics Measurement
研究概览
简要总结
The purpose of this study is to compare the pharmacokinetics (PK) of both lyophilized and liquid S95014 formulations during the induction phase after a single IV dose in newly diagnosed paediatric patients with ALL
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 1 to < 18 years
- •Patients with cytologically confirmed and documented newly diagnosed ALL according to National Comprehensive Cancer Network guidelines 2020 (see Appendix 2), excluding B-cell Burkitt ALL
- •Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2 (see Appendix 3)
- •Highly effective contraception method
- •Signed informed consent and assent, when appropriate
- •Non-inclusion Criteria:
- •Unlikely to cooperate in the study
- •Pregnant and lactating women
- •Participation in another interventional study at the same time; participation in non-interventional registries or epidemiological studies is allowed
- •Participant already enrolled in the study (informed consent signed)
- •Women of childbearing potential tested positive in a serum pregnancy test within 7 days prior to the treatment period
- •Inadequate hepatic function (bilirubin > 1.5 times upper limit of normal (ULN), transaminases > 5x ULN)
- •Inadequate renal function defined as serum creatinine > 1.5 x ULN
- •Prior treatment with chemotherapy or radiotherapy (except steroids and intrathecal therapy)
- •Prior surgery or bone marrow transplant related to the studied disease
- •Down Syndrome
- •Psychiatric illness/social situation that would limit compliance with study requirements
- •Known history of pancreatitis
- •Known history of significant liver disease
- •Known carriers of HIV antibodies
- •Significant laboratory abnormality likely to jeopardize the patients' safety or to interfere with the conduct of the study, in the investigator's opinion
- •Pre-existing known coagulopathy (e.g. haemophilia and known protein S deficiency)
- •History of previous or concurrent malignancy
- •History of sensitivity to polyethylene glycol (PEG) or PEG-based drugs
- •Severe or uncontrolled active acute or chronic infection
- •Uncontrolled intercurrent illness including life-threatening acute tumor lysis syndrome (e.g. with renal failure), symptomatic congestive heart failure, cardiac arrhythmia
排除标准
- 未提供
研究组 & 干预措施
S95014 lyophilizate
Experimental
Lyophilized S95014 reconstituted will provide 5 mL of extractable volume with the concentration of 750 U/mL. The vial of lyophilized powder (3.750 U/vial) is reconstituted with 5.2 mL of Sterile Water for Injection to obtain a 750 U/mL solution for single use.
干预措施: Lyophilized S95014 (Drug)
S95014 liquid
Active Comparator
Liquid S95014 is provided as 3.750 U per 5 mL solution in a single use vial to obtain a 750 U/mL solution for single use.
干预措施: Liquid S95014 (Drug)
结局指标
主要结局
Pharmacokinetics Measurement
时间窗: Predose up to 600 hours
Maximum observed plasma asparaginase activity (Cmax)
次要结局
- Immunogenicity Measurements(Pre-dose, post-dose (sum of 14 and 25 days post-dose))
- Pharmacokinetics Measurements(14 days post-dose)
- Activity Measurement(Day 7, 14, 18 and 25 post-dose of either liquid or lyophilized S95014)
研究者
研究点 (5)
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