05-001: Treatment of Acute Lymphoblastic Leukemia in Children
Completed · Phase 3
Conditions studied: Drug/Agent Toxicity by Tissue/Organ, Leukemia
In brief
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.
Key facts
- Study ID
- NCT00400946
- Run by
- Dana-Farber Cancer Institute
- People needed
- 800
- Starts
- 2005-04-01
- Expected to finish
- 2019-06-01
- Last updated by the study team
- 2026-07-30
Who can join
Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Dana Farber Cancer Institute — Boston, Massachusetts, United States
- Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center — New York, New York, United States
- James P. Wilmot Cancer Center at University of Rochester Medical Center — Rochester, New York, United States
- Albert Einstein Cancer Center at Albert Einstein College of Medicine — The Bronx, New York, United States
- Hasbro Children's Hospital — Providence, Rhode Island, United States
- McMaster Children's Hospital at Hamilton Health Sciences — Hamilton, Ontario, Canada
- Hopital Sainte Justine — Montreal, Quebec, Canada
- Centre de Recherche du Centre Hospitalier de l'Universite Laval — Sainte-Foy, Quebec, Canada
Full record on ClinicalTrials.gov
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