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NCT00557193 · ClinicalTrials.gov registry record · Phase 3
Combination Chemotherapy With or Without Lestaurtinib in Treating Younger Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
A Phase 3 study, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 218
- Enrollment target
NCT00557193: Completed Phase 3 study, sponsored by Children's Oncology Group.
NCT00557193 is a Phase 3 study that has completed, run by Children's Oncology Group. The registered enrollment target is 218 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00557193, a Phase 3 study, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 218 participants
- Enrollment target
Study Summary
This phase III trial studies combination chemotherapy with or without lestaurtinib with to see how well they work in treating younger patients with newly diagnosed acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of stop cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Lestaurtinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether combination chemotherapy is more effective with or without lestaurtinib in treating acute lymphoblastic leukemia.
Primary Outcome
EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. EFS is constructed using the Kaplan-Meier life table method with confidence interval based on standard errors computed using the method of Peto and Peto.
Interventions
- DRUG Cyclophosphamide
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Biopsy
- DRUG Cytarabine
- DRUG Asparaginase
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 218 participants |
| Start Date | 2008-01-15 |
| Est. Completion | 2024-06-30 |
| Phase | Phase 3 |
What the finished NCT00557193 record still lists
NCT00557193 is an interventional study that assigns participants to a tested intervention. The registered 218 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT00557193 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00557193 about?
NCT00557193 is a clinical study titled "Combination Chemotherapy With or Without Lestaurtinib in Treating Younger Patients With Newly Diagnosed Acute Lymphoblastic Leukemia". This phase III trial studies combination chemotherapy with or without lestaurtinib with to see how well they work in treating younger patients with newly diagnosed acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of stop cancer cells, either by killi...
What is the current status of trial NCT00557193?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 218 participants. The study started on 2008-01-15. Estimated completion is 2024-06-30.
What interventions are being tested in trial NCT00557193?
The interventions under investigation include: Cyclophosphamide (DRUG), Biospecimen Collection (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Cytarabine (DRUG), Asparaginase (DRUG).
Who is sponsoring clinical trial NCT00557193?
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 NCT00557193's enrollment target sits among peer trials
218 1331st of 2000 higher than 669 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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