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NCT00372593 · ClinicalTrials.gov registry record · Phase 3
Combination Chemotherapy With or Without Gemtuzumab in Treating Young Patients With Newly Diagnosed Acute Myeloid Leukemia
A Phase 3 study, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,070
- Enrollment target
NCT00372593: Completed Phase 3 study, sponsored by Children's Oncology Group.
NCT00372593 is a Phase 3 study that has completed, run by Children's Oncology Group. The registered enrollment target is 1,070 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
NCT00372593, a Phase 3 study, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,070 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as gemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving combination chemotherapy together with gemtuzumab may kill more cancer cells. It is not yet known whether combination chemotherapy is more effective with or without gemtuzumab in treating patients with newly diagnosed acute myeloid leukemia. PURPOSE: This randomized phase III trial is studying combination chemotherapy and gemtuzumab to see how well they work compared with combination chemotherapy alone in treating young patients with newly diagnosed acute myeloid leukemia.
Primary Outcome
The Kaplan-Meier method will be used to calculate estimates of Event Free Survival (EFS). The log-rank test will be used to compare survival between treatment groups. Analysis of EFS of Down syndrome patients will be performed separately. Monitoring for efficacy of GMTZ with respect to Overall Survival (OS) and EFS will utilize monitoring based on the Lan-DeMets criterion with α-spending function αt\^2 (truncated at 3 standard deviations) and 2.5% type I error.
Interventions
- DRUG etoposide
- DRUG cytarabine
- DRUG gemtuzumab ozogamicin
- DRUG asparaginase
- DRUG daunorubicin hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,070 participants |
| Start Date | 2006-08 |
| Est. Completion | 2020-09-30 |
| Phase | Phase 3 |
What the finished NCT00372593 record still lists
NCT00372593 is an interventional study that assigns participants to a tested intervention. Its 1,070 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 etoposide is the first listed.
NCT00372593 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00372593 about?
NCT00372593 is a clinical study titled "Combination Chemotherapy With or Without Gemtuzumab in Treating Young Patients With Newly Diagnosed Acute Myeloid Leukemia". RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as gemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spr...
What is the current status of trial NCT00372593?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,070 participants. The study started on 2006-08. Estimated completion is 2020-09-30.
What interventions are being tested in trial NCT00372593?
The interventions under investigation include: etoposide (DRUG), cytarabine (DRUG), gemtuzumab ozogamicin (DRUG), asparaginase (DRUG), daunorubicin hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00372593?
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 NCT00372593's enrollment target sits among peer trials
1,070 272nd of 2000 higher than 1,729 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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