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NCT00071799 · ClinicalTrials.gov registry record · Phase 3
A Survival Study in Patients With High Risk Myelodysplastic Syndromes Comparing Azacitidine Versus Conventional Care
A Phase 3 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 3
- Development phase
- 358
- Enrollment target
NCT00071799: Completed Phase 3 study, sponsored by Celgene.
NCT00071799 is a Phase 3 study that has completed, run by Celgene. The registered enrollment target is 358 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (54% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00071799, a Phase 3 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 358 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether patients with high-risk myelodysplastic syndromes (MDS) treated with azacitidine have improved survival compared to conventional care treatments. The study will also assess the effect of treatments on response, duration of response, and transformation to acute myeloid leukemia (AML). The study will continue for 12 months following last patient enrolled. See study AZA PH GL 2003 CL 001 E for information about the extension to this study.
Primary Outcome
Kaplan-Meier estimates for the median months until death from any cause within the intent-to-treat population. Patients surviving at the end of the follow-up period were censored at the date of last contact. If a patient withdrew consent to follow-up or was lost to follow-up, the patient was censored as of the last date of contact.
Interventions
- DRUG Azacitidine
- OTHER Physician Choice
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 358 participants |
| Start Date | 2003-11-01 |
| Est. Completion | 2007-07-01 |
| Phase | Phase 3 |
What the finished NCT00071799 record still lists
NCT00071799 is an interventional study that assigns participants to a tested intervention. The registered 358 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 (54% lower).
The record links to 0 conditions, and to 2 interventions - of which Azacitidine is the first listed.
NCT00071799 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00071799 about?
NCT00071799 is a clinical study titled "A Survival Study in Patients With High Risk Myelodysplastic Syndromes Comparing Azacitidine Versus Conventional Care". The purpose of this study is to determine whether patients with high-risk myelodysplastic syndromes (MDS) treated with azacitidine have improved survival compared to conventional care treatments. The study will also assess the effect of treatments on response, duration of response, and transformatio...
What is the current status of trial NCT00071799?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 358 participants. The study started on 2003-11-01. Estimated completion is 2007-07-01.
What interventions are being tested in trial NCT00071799?
The interventions under investigation include: Azacitidine (DRUG), Physician Choice (OTHER).
Who is sponsoring clinical trial NCT00071799?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00071799's enrollment target sits among peer trials
358 1022nd of 2000 higher than 978 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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