Trial Information

Pharmacology and Toxicity of Erwinia Asparaginase (Erwinase®; Crisantaspase; IND 290) Following Allergy to PEG-Asparaginase in Treatment of Children With Acute Lymphoblastic Leukemia (ALL)

OBJECTIVES:

Primary

- 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.

- To determine the frequency of asparaginase-related toxicity in these patients.

- To characterize the pharmacokinetics of Erwinia asparaginase in these patients.

Secondary

- To compare serum asparaginase activity and serum asparagine concentration between
patients treated with Erwinia asparaginase on this trial and historical controls
treated with PEG-asparaginase on CCG-1961 and CCG-1962.

- To determine the 72-hour serum asparaginase activity on days 8 or 11 or 13 based on the
starting date of Erwinia asparaginase therapy.

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

- To determine if serum asparagine is adequately depleted on days 12 or 13 in a subset of
these patients.

OUTLINE: This is a multicenter study.

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.