AALL07P2 Pharmacology and Toxicity of Erwinia Asparaginase (ErwinaseÂ®; Crisantaspase; IND 290) Following Allergy to PEG-Asparaginase in Treatment of Children with Acute Lymphoblastic Leukemia (ALL)
â?¢To determine if the 48-hour trough serum asparaginase activity is ? 0.1 IU/mL in young patients with acute lymphoblastic leukemia treated with Erwinia asparaginase after allergy to PEG-asparaginase. â?¢To determine the frequency of asparaginase-related toxicity in these patients. â?¢To characterize the pharmacokinetics of Erwinia asparaginase in these patients.
Age: 1-30 years Diagnosis of acute lymphoblastic leukemia Concurrently enrolled on a frontline Children's Oncology Group treatment trial (i.e., COG-AALL0232 or COG-AALL0531, COG-AALL0331, or COG-AALL0434) at a participating institution oMust have 1 or more courses of asparaginase remaining to be administered on the treatment protocol Must have had a grade ? 2 hypersensitivity reaction to PEG-asparaginase No history of pancreatitis ? grade 2 No prior Erwinia asparaginase
Patients receive 6 doses of Erwinia asparaginase intramuscularly on a Monday/Wednesday/Friday schedule as a replacement for each scheduled dose of PEG-asparaginase remaining on the original treatment protocol. All other chemotherapy continues according to the original treatment protocol. Blood samples are collected periodically for pharmacokinetic, pharmacodynamic, and antibody studies. After completion of study treatment, patients are followed periodically.
05/24/2013 04:02 AM