05-001: Treatment of Acute Lymphoblastic Leukemia in Children
Public ClinicalTrials.gov record NCT00400946. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Treatment of Acute Lymphoblastic Leukemia in Children
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00400946
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 800 participants
Conditions and interventions
Conditions
Interventions
- asparaginase Drug
- cyclophosphamide Drug
- cytarabine Drug
- dexamethasone Drug
- dexrazoxane hydrochloride Drug
- doxorubicin hydrochloride Drug
- etoposide Drug
- leucovorin calcium Drug
- mercaptopurine Drug
- methotrexate Drug
- methylprednisolone Drug
- pegaspargase Drug
- prednisolone Drug
- therapeutic hydrocortisone Drug
- vincristine sulfate Drug
- radiation therapy Radiation
Drug · Radiation
Eligibility (public fields only)
- Age range
- 1 Year to 18 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 2005 (Actual)
- Primary completion
- Aug 2014 (Actual)
- Completion
- Jun 2019 (Actual)
- Last update posted
- Jul 30, 2026
2005 – 2019
United States locations
- U.S. sites
- 5
- U.S. states
- 3
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | — |
| Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | New York | New York | 10032 | — |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York | 14642 | — |
| Albert Einstein Cancer Center at Albert Einstein College of Medicine | The Bronx | New York | 10461 | — |
| Hasbro Children's Hospital | Providence | Rhode Island | 02903 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00400946, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 30, 2026 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00400946 live on ClinicalTrials.gov.