RBR-3gz8hc尚未招募2 期
A Clinical Phase II Trial to Describe Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of Spectrila® with thePharmaceutical Active Ingredient Recombinant L-Asparaginase in Adult Subjects with Newly Diagnosed Acute B-Cell Lymphoblastic Leukaemia
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da USP0 个研究点开始时间: 2017年9月20日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Intervention
入排标准
- 年龄范围
- 18Y 至 —（—）
入选标准
- •Subjects with newly diagnosed pathologically confirmed acute B-cell lymphoblastic leukaemia; Female or male higher or equal to 18 years of age; Eligible for treatment and treated according to the underlying treatment protocol BRALL 2014; Written informed consent given freely; Subject expresses his/her understanding of the trial procedures and willingness to abide by them during the course of the trial; Female subjects of child-bearing potential must use a highly effective method of contraception (pearl index less than 1%) in combination with a second method of contraception during the trial and for at least 3 months after Spectrila discontinuation; Men should use effective contraceptive measures and be advised to not father a child while receiving ASNase.
排除标准
- •Pre-treatment with any ASNase preparation;
- •Hypersensitivity to the active substance, Escherichia coli-ASNase preparation or to any of the excipients; Pancreatitis at the time of treatment initiation or history of pancreatitis; Pre-existing known coagulopathy; Severe liver function impairment; History of serious haemorrhage or serious thrombosis; Other current malignancies; Uncontrolled active infection; Evidence of infection with the human immunodeficiency virus, hepatitis B or C, human T-lymphotropic virus type I and
- •II, syphilis or Chagas disease (American trypanosomiasis); Pregnancy as verified by a positive pregnancy test or nursing woman; Active psychiatric or mental illness making informed consent or careful clinical follow-up unlikely; Evidence or suspicion that the subject might not comply with the requirements of the trial protocol; Evidence or suspicion that the subject is unwilling or unable to
- •understand the information given to him/her within the informed consent procedure; Any other factor which in the investigator’s opinion is likely to compromise the subject’s ability to participate in the trial; The subject is an employee or direct relative of an employee of the contract research organisation (CRO) involved in the trial,
- •the trial site or medac; The subject is imprisoned or is lawfully kept in an institution; The subject has participated within 3 months before screening or plans to participate in a clinical trial (except the underlying treatment protocol BRALL 2014); Previous participation in this clinical trial.
研究者
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