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NCT00866307 · ClinicalTrials.gov registry record · Phase 1
Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia (Closed to Accrual 4-22-2011)
A Phase 1 study, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 1
- Development phase
- 104
- Enrollment target
NCT00866307: Completed Phase 1 study, sponsored by Children's Oncology Group.
NCT00866307 is a Phase 1 study that has completed, run by Children's Oncology Group. The registered enrollment target is 104 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00866307, a Phase 1 study, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 104 participants
- Enrollment target
Study Summary
This pilot clinical trial studies the side effects of pegaspargase when given together with combination chemotherapy in treating patients with newly diagnosed high-risk acute lymphoblastic leukemia. Pegaspargase may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) together with pegaspargase may kill more cancer cells.
Primary Outcome
Percentage of Group B (High Risk-High) patients taking less than 49 weeks from day 1 of consolidation to day 1 of maintenance therapy. Only Group B analyzed since this is prespecified in protocol.
Interventions
- DRUG Cyclophosphamide
- DRUG Doxorubicin Hydrochloride
- DRUG Dexamethasone
- DRUG Cytarabine
- DRUG Daunorubicin Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2009-02-23 |
| Est. Completion | 2021-03-31 |
| Phase | Phase 1 |
What the finished NCT00866307 record still lists
NCT00866307 is an interventional study that assigns participants to a tested intervention. The registered 104 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% higher).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT00866307 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00866307 about?
NCT00866307 is a clinical study titled "Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia (Closed to Accrual 4-22-2011)". This pilot clinical trial studies the side effects of pegaspargase when given together with combination chemotherapy in treating patients with newly diagnosed high-risk acute lymphoblastic leukemia. Pegaspargase may stop the growth of cancer cells by blocking some of the enzymes needed for cell grow...
What is the current status of trial NCT00866307?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 104 participants. The study started on 2009-02-23. Estimated completion is 2021-03-31.
What interventions are being tested in trial NCT00866307?
The interventions under investigation include: Cyclophosphamide (DRUG), Doxorubicin Hydrochloride (DRUG), Dexamethasone (DRUG), Cytarabine (DRUG), Daunorubicin Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00866307?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00866307's enrollment target sits among peer trials
104 536th of 2000 higher than 1,460 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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