Erwinia Asparaginase After Allergy to PEG-Asparaginase in Treating Young Patients With Acute Lymphoblastic Leukemia

Primary Aims

1. To determine if the 48 hour trough serum asparaginase activity is ≥0.1 IU/mL.

2. To determine the frequency of asparaginase-related toxicity following Erwinase®
treatment.

3. To characterize the pharmacokinetics of Erwinase in children with leukemia and allergy
to PEG-asparaginase.

Secondary

1. To informally compare serum asparaginase activity and plasma asparagine concentration
between patients treated with Erwinase® on this trial and historical controls treated
with PEG-asparaginase on CCG-1962 and 1961.

2. To determine the 72 hour serum asparaginase activity (Day 8 (pre-dose 4) if the course
of Erwinase® is started on Monday; Day 13 (pre-dose 6) if the course of Erwinase® is
started on Wednesday; and Day 11 (pre-dose 5) if the course of Erwinase® is started on
Friday).

3. To determine the presence of anti-Erwinia asparaginase antibodies in children treated
with a course(s) of Erwinase® following clinical allergy to PEG -asparaginase (PEG,
pegaspargase).

4. To determine if plasma asparagine is adequately depleted (Day 12 (pre-dose 6) if the
course of Erwinase® is started on Monday; Day 13 (pre-dose 6) if the course of
Erwinase® is started on Wednesday or Friday) in a subset of patients.

Patients receive 6 doses of Erwinia asparaginase intramuscularly (IM) 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.

Inclusion Criteria:

- 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

- Must 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