Trial of Oncaspar® and Three Doses of Pegylated Recombinant Asparaginase in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukaemia

Inclusion Criteria: * Previously untreated acute lymphoblastic leukaemia (pro-B, common, pre-B, early T, thymic T, mature T) * Age 18 years - 55 years * Treatment according to German Multicenter Trials for adult Acute Lymphoblastic Leukaemia (GMALL) 07/2003 protocol or subsequent GMALL protocols for patients with de novo ALL * Written informed consent * Women of child-bearing potential or partner of men with child-bearing potential must use a highly effective method of contraception * Negative pregnancy test for women of child-bearing potential Exclusion Criteria: * Patients with Philadelphia chromosome (BCR-ABL) positive ALL * Severe comorbidity or leukaemia-associated complications * Known hypersensitivity to asparaginase * History of severe pancreatitis * History of thrombosis or pulmonary embolism * Pre-existing clinically relevant coagulopathy * Liver dysfunction (e.g. acute or current hepatitis, alcohol or drug abuse) or history of clinically relevant liver disease * Bilirubin \> 1.5 x Upper Limit Norm (ULN) * Other current malignancies * Severe psychiatric illness or other circumstances which may compromise the cooperation of the patient or the ability to give informed consent * Body mass index \> 30 kg/m² * Known pregnancy, breast feeding