Ensaios Clínicos (somente visualização)

Listagem completa dos ensaios clĂ­nicos importados do XML ICTRP.

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1392
RBR-3gz8hc
A Clinical Trial of Spectrila® in Adult Subjects with Newly Diagnosed Acute Lymphoblastic Leukaemia
A Clinical Phase II Trial to Describe Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of Spectrila® with the Pharmaceutical Active Ingredient Recombinant L-Asparaginase in Adult Subjects with Newly Diagnosed Acute B-Cell Lymphoblastic Leukaemia
None
Not yet recruiting
Intervention
2, single-arm-study, open
2
None
None
None
2017-09-20
2017-12-15
None
None
Hospital das ClĂ­nicas da Faculdade de Medicina de RibeirĂŁo Preto da USP
INC Research BR Serviços de Pesquisas Clínicas Ltda.
https://ensaiosclinicos.gov.br/rg/RBR-3gz8hc
None
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.
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.
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2026-05-11 05:17:48