Treatment of Acute Lymphoblastic Leukemia in Children
Status:
Completed
Trial end date:
2019-06-01
Target enrollment:
Participant gender:
Summary
RATIONALE: L-asparaginase is an important component of treatment for childhood acute
lymphoblastic leukemia, but is also associated with notable side-effects, including
hypersensitivity, pancreatitis, and thrombosis. We have previously reported that patients
with acute lymphoblastic leukemia in whom asparaginase treatment was discontinued because of
intolerable side-effects had survival outcomes that were inferior to those who received all
or nearly all of their intended doses. Two bacterial sources of asparaginase exist:
Escherichia coli (E coli) and Erwinia chrysanthemia (Erwinia). Generally, the E coli-derived
enzyme has been used as front-line therapy and the Erwinia-derived preparation has been
reserved for patients who develop hypersensitivity reactions. Pegylated E coli asparaginase
(PEG-asparaginase) has a longer half-life and is potentially less immunogenic than native E
coli L-asparaginase, and has been used as the initial asparaginase preparation in some
pediatric acute lymphoblastic leukemia treatment regimens.
PURPOSE: Although the pharmacokinetics of each of these asparaginase preparations:
intravenous PEG-asparaginase (IV-PEG) and intramuscular native E coli L-asparaginase (IM-EC)
have been well characterized, their relative efficacy and toxicity have not been studied
extensively.