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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: Completed Phase 3 study, sponsored by Dana-Farber Cancer Institute.
NCT00400946 is a Phase 3 study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 800 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Asparaginase-related toxicity rate is defined as the percentage of patients who experience allergy (all grades), symptomatic pancreatitis (grade 2 or worse), thrombotic or bleeding complications requiring intervention (grade 2 or worse) with treatment attribution of possibly, probably or definite based on CTCAEv3.
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 |
What the finished NCT00400946 record still lists
NCT00400946 is an interventional study that assigns participants to a tested intervention. The registered 800 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which cyclophosphamide is the first listed.
NCT00400946 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00400946's enrollment target sits among peer trials
800 414th of 2000 higher than 1,573 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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