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
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- medac GmbH
- 入组人数
- 56
- 试验地点
- 30
- 主要终点
- To compare the rate of patients with asparagine depletion 3 weeks after infusion of PEG-rASNase or Oncaspar® in the induction phase.
研究概览
简要总结
This is an assessment of efficacy and safety of three different doses of pegylated recombinant asparaginase (PEG-rASNase) in comparison to Oncaspar® during treatment of adults with de novo acute lymphoblastic leukaemia (ALL). This study will provide first data for determining specific asparaginase doses to yield various durations of L-asparagine (ASN) depletion which are required within different treatment phases of ALL therapy.
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously untreated acute lymphoblastic leukaemia (pro-B, common, pre-B, early T, thymic T, mature T)
- •Age 18 years - 55 years
- •Treatment according to German Multicenter Trials for adult Acute Lymphoblastic Leukaemia (GMALL) 07/2003 protocol or subsequent GMALL protocols for patients with de novo ALL
- •Written informed consent
- •Women of child-bearing potential or partner of men with child-bearing potential must use a highly effective method of contraception
- •Negative pregnancy test for women of child-bearing potential
排除标准
- •Patients with Philadelphia chromosome (BCR-ABL) positive ALL
- •Severe comorbidity or leukaemia-associated complications
- •Known hypersensitivity to asparaginase
- •History of severe pancreatitis
- •History of thrombosis or pulmonary embolism
- •Pre-existing clinically relevant coagulopathy
- •Liver dysfunction (e.g. acute or current hepatitis, alcohol or drug abuse) or history of clinically relevant liver disease
- •Bilirubin > 1.5 x Upper Limit Norm (ULN)
- •Other current malignancies
- •Severe psychiatric illness or other circumstances which may compromise the cooperation of the patient or the ability to give informed consent
- •Body mass index > 30 kg/m²
- •Known pregnancy, breast feeding
研究组 & 干预措施
PEG-rASNase 500
500 U/m2 BSA at day 0
干预措施: PEG-rASNase (Drug)
PEG-rASNase 1000
1000 U/m2 BSA at day 0
干预措施: PEG-rASNase (Drug)
PEG-rASNase 1500
1500 U/m2 at day 0
干预措施: PEG-rASNase (Drug)
Oncaspar
2000 U/m2 at day 0
干预措施: Oncaspar (Drug)
结局指标
主要结局
To compare the rate of patients with asparagine depletion 3 weeks after infusion of PEG-rASNase or Oncaspar® in the induction phase.
时间窗: 3 weeks
To compare the rate of patients with asparagine depletion 3 weeks after infusion of PEG-rASNase or Oncaspar® in the induction phase.
次要结局
- Comparing of treatment arms(62 days)