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NCT00059839 · ClinicalTrials.gov registry record · Phase 3
Comparison of Two Combination Chemotherapy Regimens With Either Vincristine or Vinblastine in Treating Patients With Advanced Anaplastic Large Cell Lymphoma
A Phase 3 study, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 129
- Enrollment target
NCT00059839: Completed Phase 3 study, sponsored by Children's Oncology Group.
NCT00059839 is a Phase 3 study that has completed, run by Children's Oncology Group. The registered enrollment target is 129 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00059839, a Phase 3 study, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 129 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 if combination chemotherapy with vinblastine is more effective than combination chemotherapy with vincristine in treating advanced anaplastic large cell lymphoma. PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens with either vinblastine or vincristine in treating patients who have newly diagnosed advanced anaplastic large cell lymphoma.
Primary Outcome
Percentage of EFS patients. This is measured as the time from study entry until disease progression, disease recurrence, occurrence of a second malignant neoplasm, or death from any cause. To measure Event Free Survival, repeated one-sided logrank tests will be performed The upper critical values are based on the one-sided alpha-spending functions of t2 (alpha=0.05) and the lower critical values are based on testing the alternative hypothesis at 0.005 level.
Interventions
- DRUG prednisone
- DRUG mercaptopurine
- DRUG methotrexate
- DRUG doxorubicin hydrochloride
- DRUG vinblastine sulfate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 129 participants |
| Start Date | 2003-11 |
| Est. Completion | 2014-07 |
| Phase | Phase 3 |
What the finished NCT00059839 record still lists
NCT00059839 is an interventional study that assigns participants to a tested intervention. The registered 129 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 (83% lower).
The record links to 0 conditions, and to 5 interventions - of which prednisone is the first listed.
NCT00059839 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00059839 about?
NCT00059839 is a clinical study titled "Comparison of Two Combination Chemotherapy Regimens With Either Vincristine or Vinblastine in Treating Patients With Advanced Anaplastic Large Cell Lymphoma". 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 if combination chemotherapy with vinblastine is more effective than combination chemotherapy with vinc...
What is the current status of trial NCT00059839?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 129 participants. The study started on 2003-11. Estimated completion is 2014-07.
What interventions are being tested in trial NCT00059839?
The interventions under investigation include: prednisone (DRUG), mercaptopurine (DRUG), methotrexate (DRUG), doxorubicin hydrochloride (DRUG), vinblastine sulfate (DRUG).
Who is sponsoring clinical trial NCT00059839?
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 NCT00059839's enrollment target sits among peer trials
129 1597th of 2000 higher than 400 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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