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

Inclusion criteria

• ✓. 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.