Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00005596 · ClinicalTrials.gov registry record · Phase 3
Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Lymphoblastic Leukemia
A Phase 3 study, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,076
- Enrollment target
NCT00005596: Completed Phase 3 study, sponsored by Children's Oncology Group.
NCT00005596 is a Phase 3 study that has completed, run by Children's Oncology Group. The registered enrollment target is 1,076 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (39% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00005596, a Phase 3 study, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,076 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which regimen of chemotherapy is more effective for acute lymphoblastic leukemia. PURPOSE: This randomized phase III trial is comparing four regimens of combination chemotherapy to see how well they work in treating children with newly diagnosed acute lymphoblastic leukemia.
Primary Outcome
The overall plan is to accrue for 3.1 years or until all accrual goals have been met, whichever occurs first. Since power is determined by event-rates, lower or higher than expected event rates could lead to an amendment to alter the accrual goal. This consideration will be made independent of arm-specific outcome, in order to eliminate bias
Interventions
- DRUG cyclophosphamide
- DRUG dexamethasone
- DRUG leucovorin calcium
- DRUG cytarabine
- DRUG daunorubicin hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,076 participants |
| Start Date | 2000-04 |
| Est. Completion | 2007-07 |
| Phase | Phase 3 |
What the finished NCT00005596 record still lists
NCT00005596 is an interventional study that assigns participants to a tested intervention. Its 1,076 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (39% higher).
The record links to 0 conditions, and to 5 interventions - of which cyclophosphamide is the first listed.
NCT00005596 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00005596 about?
NCT00005596 is a clinical study titled "Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Lymphoblastic Leukemia". RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which regimen of chemotherapy is more effective for acute lymphoblastic leukemia. PURPOSE: This rando...
What is the current status of trial NCT00005596?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,076 participants. The study started on 2000-04. Estimated completion is 2007-07.
What interventions are being tested in trial NCT00005596?
The interventions under investigation include: cyclophosphamide (DRUG), dexamethasone (DRUG), leucovorin calcium (DRUG), cytarabine (DRUG), daunorubicin hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00005596?
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 NCT00005596's enrollment target sits among peer trials
1,076 270th of 2000 higher than 1,730 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT07084883 · 1,076 participants
Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration
- NCT06658808 · 1,075 participants · NA
Efficacy-Implementation Study for PC CARES in Rural Alaska
- NCT06159673 · 1,074 participants · Phase 2
ACP-204 in Adults With Alzheimer's Disease Psychosis
- NCT06074068 · 1,080 participants · NA
Father-Focused Intervention for Reducing Family Violence and Symptoms in Children
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia