EICHOR
● Completed
05-001: Treatment of Acute Lymphoblastic Leukemia in Children
Condition: Drug/Agent Toxicity by Tissue/Organ · Leukemia · Sponsor: Dana-Farber Cancer Institute
About this study
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.
This description comes directly from the study's public registry record.
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Locations (8)
| 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 | — |
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Source record: clinicaltrials.gov/study/NCT00400946