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

Launched by MEDAC GMBH · Dec 1, 2010

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• 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