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NCT00492401 · ClinicalTrials.gov registry record · Phase 2
Decitabine in Treating Patients With Previously Untreated Acute Myeloid Leukemia
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 55
- Enrollment target
NCT00492401: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00492401 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 55 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00492401, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 55 participants
- Enrollment target
Study Summary
This phase II trial is studying how well decitabine works in treating patients with previously untreated acute myeloid leukemia. Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing
Primary Outcome
Per International Working Group criteria: Morphologic complete remission (CRm): Defined as morphologic leukemia-free state, including \<5% blasts in BM aspirate with marrow spicules and a count of \> 200 nucleated cells and no blasts with Auer rods, no persistent extramedullary disease, ANC \> 1000/uL, platelet count \> 100,000/uL. Patient must be independent of transfusions for a minimum of 1 week before each marrow assessment. Morphologic complete remission with incomplete blood count recovery
Interventions
- GENETIC microarray analysis
- OTHER laboratory biomarker analysis
- OTHER pharmacological study
- DRUG decitabine
- OTHER high performance liquid chromatography
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2007-05 |
| Est. Completion | 2014-10 |
| Phase | Phase 2 |
What the finished NCT00492401 record still lists
NCT00492401 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower).
The record links to 0 conditions, and to 5 interventions - of which microarray analysis is the first listed.
NCT00492401 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00492401 about?
NCT00492401 is a clinical study titled "Decitabine in Treating Patients With Previously Untreated Acute Myeloid Leukemia". This phase II trial is studying how well decitabine works in treating patients with previously untreated acute myeloid leukemia. Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing
What is the current status of trial NCT00492401?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 55 participants. The study started on 2007-05. Estimated completion is 2014-10.
What interventions are being tested in trial NCT00492401?
The interventions under investigation include: microarray analysis (GENETIC), laboratory biomarker analysis (OTHER), pharmacological study (OTHER), decitabine (DRUG), high performance liquid chromatography (OTHER).
Who is sponsoring clinical trial NCT00492401?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00492401's enrollment target sits among peer trials
55 1153rd of 2000 higher than 841 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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