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

• Status: Terminated
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: medac GmbH
• Treatments: Asparaginase; Pegaspargase

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