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

A Randomized, Multi-centre, Parallel-group, Open Label, Oncaspar® Controlled Dose Ranging Trial of Three Doses of Pegylated Recombinant Asparaginase in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukaemia

This is an assessment of efficacy and safety of three different doses of pegylated recombinant asparaginase (PEG-rASNase) in comparison to Oncaspar® during treatment of adults with de novo acute lymphoblastic leukaemia (ALL). This study will provide first data for determining specific asparaginase doses to yield various durations of L-asparagine (ASN) depletion which are required within different treatment phases of ALL therapy.

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