05-001: Treatment of Acute Lymphoblastic Leukemia in Children
Phase 3
Completed
NCT00400946
| Condition | Drug/Agent Toxicity by Tissue/Organ, Leukemia |
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| Phase | Phase 3 |
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| Sponsor | Dana-Farber Cancer Institute |
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| Status | Completed |
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| Enrollment | 800 participants |
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| Interventions | asparaginase, cyclophosphamide, cytarabine, dexamethasone, dexrazoxane hydrochloride |
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| Start date | Apr, 2005 |
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| Completion date | Aug, 2014 |
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| Results posted | Jun 14, 2017 |
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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-aspara
Asparaginase-Related Toxicity Rate
30-week post-induction asparaginase treatment period · percentage of participants
| Intramuscular Native E Coli L-asparaginase (IM-EC) | 26 percentage of participants |
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| Intravenous PEG-asparaginase (IV-PEG) | 28 percentage of participants |
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Open in BENITIONS
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