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NCT00621023 · ClinicalTrials.gov registry record · Phase 2
Cephalon Decitabine, Arsenic Trioxide and Ascorbic Acid for Myelodysplastic Syndrome
A Phase 2 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
NCT00621023: Completed Phase 2 study, sponsored by Duke University.
NCT00621023 is a Phase 2 study that has completed, run by Duke University. The registered enrollment target is 7 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00621023, a Phase 2 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
Study Summary
This will be an open-label, non-randomized trial pilot phase II trial open to patients with myelodysplastic syndrome. The purpose of the study is to find out if the combination of decitabine, arsenic trioxide and ascorbic acid is safe.
Primary Outcome
Complete response and Partial response are defined using 2000 international working group (IWG) criteria. The Primary criteria for a CR is a repeat bone marrow showing \< 5% myeloblasts with normal maturation of all cell lines, with no evidence for dysplasia . A PR meets all the CR criteria except Blasts decreased by \>50% over pretreatment, or a less advanced myelodysplastic syndrome (MDS) French American British (FAB) classification than pretreatment.
Interventions
- DRUG Decitabine, Arsenic Trioxide and Ascorbic Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2007-11 |
| Est. Completion | 2010-04 |
| Phase | Phase 2 |
What the finished NCT00621023 record still lists
NCT00621023 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Decitabine, Arsenic Trioxide and Ascorbic Acid is the first listed.
NCT00621023 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00621023 about?
NCT00621023 is a clinical study titled "Cephalon Decitabine, Arsenic Trioxide and Ascorbic Acid for Myelodysplastic Syndrome". This will be an open-label, non-randomized trial pilot phase II trial open to patients with myelodysplastic syndrome. The purpose of the study is to find out if the combination of decitabine, arsenic trioxide and ascorbic acid is safe.
What is the current status of trial NCT00621023?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2007-11. Estimated completion is 2010-04.
What interventions are being tested in trial NCT00621023?
The interventions under investigation include: Decitabine, Arsenic Trioxide and Ascorbic Acid (DRUG).
Who is sponsoring clinical trial NCT00621023?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00621023's enrollment target sits among peer trials
7 1996th of 2000 higher than 5 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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