RBR-3gz8hc
Not yet recruiting
Phase 2
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 sitesSeptember 20, 2017
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Acute Lymphoblastic Leukaemia
- Sponsor
- Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da USP
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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