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NCT00400946 · ClinicalTrials.gov registry record · Phase 3
05-001: Treatment of Acute Lymphoblastic Leukemia in Children
A Phase 3 study, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 3
- Development phase
- 800
- Enrollment target
NCT00400946 is a Phase 3 study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 800 participants.
The verdict
NCT00400946, a Phase 3 study, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 800 participants
- Enrollment target
Study 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.
Interventions
- DRUG cyclophosphamide
- DRUG dexamethasone
- DRUG dexrazoxane hydrochloride
- DRUG cytarabine
- DRUG asparaginase
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 800 participants |
| Start Date | 2005-04 |
| Est. Completion | 2019-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00400946
The ClinicalTrials.gov registry entry for NCT00400946 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 800 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dana-Farber Cancer Institute, which has 781 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which cyclophosphamide is the first listed.
NCT00400946 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00400946 about?
NCT00400946 is a clinical study titled "05-001: Treatment of Acute Lymphoblastic Leukemia in Children". 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...
What is the current status of trial NCT00400946?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 800 participants. The study started on 2005-04. Estimated completion is 2019-06.
What interventions are being tested in trial NCT00400946?
The interventions under investigation include: cyclophosphamide (DRUG), dexamethasone (DRUG), dexrazoxane hydrochloride (DRUG), cytarabine (DRUG), asparaginase (DRUG).
Who is sponsoring clinical trial NCT00400946?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
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