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NCT00333840 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Imatinib Versus Interferon-α Plus Cytarabine in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,106
- Enrollment target
NCT00333840: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT00333840 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 1,106 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (43% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00333840, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,106 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate and compare the side effects and anti-leukemic benefits of imatinib with those of interferon and Ara-C for patients who have chronic myeloid leukemia (CML) in the chronic phase. Patients in this study will be randomized (1:1) to receive either interferon plus Ara-C or imatinib as initial treatment.
Primary Outcome
Overall survival was defined as the time between date of randomization and death due to any cause. The time was censored at last examination date for patients who were still being treated and at date of last contact for patients who discontinued treatment. Kaplan-Meier estimates of the percentage of participants at each time point was calculated. This outcome was measured in all randomized patients, regardless of whether crossover occurred, i.e., events that occurred in patients, who had crossed
Interventions
- DRUG imatinib mesilate
- DRUG interferon-alpha (INF-a)
- DRUG cytarabine (ARA-C)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,106 participants |
| Start Date | 2000-06 |
| Est. Completion | 2012-03 |
| Phase | Phase 3 |
What the finished NCT00333840 record still lists
NCT00333840 is an interventional study that assigns participants to a tested intervention. Its 1,106 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 (43% higher).
The record links to 0 conditions, and to 3 interventions - of which imatinib mesilate is the first listed.
NCT00333840 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00333840 about?
NCT00333840 is a clinical study titled "Safety and Efficacy of Imatinib Versus Interferon-α Plus Cytarabine in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia". The purpose of this study is to evaluate and compare the side effects and anti-leukemic benefits of imatinib with those of interferon and Ara-C for patients who have chronic myeloid leukemia (CML) in the chronic phase. Patients in this study will be randomized (1:1) to receive either interferon plus...
What is the current status of trial NCT00333840?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,106 participants. The study started on 2000-06. Estimated completion is 2012-03.
What interventions are being tested in trial NCT00333840?
The interventions under investigation include: imatinib mesilate (DRUG), interferon-alpha (INF-a) (DRUG), cytarabine (ARA-C) (DRUG).
Who is sponsoring clinical trial NCT00333840?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00333840's enrollment target sits among peer trials
1,106 251st of 2000 higher than 1,750 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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