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NCT00538876 · ClinicalTrials.gov registry record · Phase 1
Phase I Epigenetic Priming Using Decitabine With Induction Chemotherapy in AML
A Phase 1 study, sponsored by Weill Medical College of Cornell University.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT00538876: Completed Phase 1 study, sponsored by Weill Medical College of Cornell University.
NCT00538876 is a Phase 1 study that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00538876, a Phase 1 study, has completed, sponsored by Weill Medical College of Cornell University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
This is an open label phase I study designed to explore the feasibility, safety and biologic activity of epigenetic priming with decitabine prior to standard cytarabine, daunorubicin induction chemotherapy in younger patients with less-than-favorable risk AML. Primary Objective: To find an appropriate dose level for decitabine when used as priming for cytarabine and daunorubicin "7+3" induction chemotherapy in AML. Secondary Objectives: 1. To establish the safety and expected toxicities of decitabine when used as priming for cytarabine and daunorubicin "7+3" induction chemotherapy in AML. 2. To establish the optimal dose schedule of decitabine required to broadly demethylate cytosine residues in genomic regulatory regions. 3. To investigate, in selected cases, the molecular and cellular consequences of decitabine-induced hypomethylation by a) establishing the extent and degree of hypomethylation at specific genomic loci required to reactivate the expression of repressed genes and by b) determining the effect of hypomethylation on the differentiation and/or apoptosis of leukemic blasts.
Interventions
- DRUG decitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2007-07 |
| Est. Completion | 2009-12 |
| Phase | Phase 1 |
What the finished NCT00538876 record still lists
NCT00538876 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 1 intervention - of which decitabine is the first listed.
NCT00538876 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00538876 about?
NCT00538876 is a clinical study titled "Phase I Epigenetic Priming Using Decitabine With Induction Chemotherapy in AML". This is an open label phase I study designed to explore the feasibility, safety and biologic activity of epigenetic priming with decitabine prior to standard cytarabine, daunorubicin induction chemotherapy in younger patients with less-than-favorable risk AML. Primary Objective: To find an appropri...
What is the current status of trial NCT00538876?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2007-07. Estimated completion is 2009-12.
What interventions are being tested in trial NCT00538876?
The interventions under investigation include: decitabine (DRUG).
Who is sponsoring clinical trial NCT00538876?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00538876's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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