PK, PD, Safety and Immunogenicity of Spectrila in Adults With Acute B-cell Lymphoblastic Leukaemia

Prior treatment

• Pre-treatment with any ASNase preparation
• 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 -

Other illness

• 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
• History of serious haemorrhage or serious thrombosis
• Other current malignancies
• Uncontrolled active infection
• Evidence of infection with severe acute respiratory syndrome coronavirus typ 2 (SARS-CoV-2), the human immunodeficiency virus, hepatitis B or C, human T-lymphotropic virus type I and II, syphilis or Chagas disease (American trypanosomiasis)
• Active psychiatric or mental illness making informed consent or careful clinical follow-up unlikely

Lab values

• Severe liver function impairment (bilirubin > three times the upper limit of normal [ULN]; transaminases > ten times ULN)

Other

• Pre-existing known coagulopathy
• Pregnancy as verified by a positive pregnancy test or nursing woman
• 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.

• Subjects with newly diagnosed pathologically confirmed acute B-cell lymphoblastic leukaemia
• Female or male subjects between 18 and 55 years of age (inclusive)
• Subjects eligible for treatment and treated according to the underlying treatment protocol BRALL 2014
• Written informed consent given freely after the nature of the trial and disclosure of data has been explained to the subject
• The subject shows no evidence of a current infection with SARS-CoV-2 (as diagnosed by thorax tomography or PCR test or test for anti-SARS-CoV-2 antibodies).
• The 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%) such as complete sexual abstinence, combined oral contraceptive, vaginal hormone ring, transdermal contraceptive patch, contraceptive implant or depot contraceptive injection in combination with a second method of contraception like a condom or a cervical cap/diaphragm with spermicide during the trial and for at least 7 months after Spectrila discontinuation.
• Men should use effective contraceptive measures and be advised to not father a child while receiving ASNase. As a precautionary measure it is recommended to wait at least for 4 months after completion of treatment.