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NCT01177540 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of Decitabine as Epigenetic Priming With Induction Chemotherapy in Pediatric Acute Myelogenous Leukemia (AML) Subjects
A Phase 2 study, sponsored by Eisai.
- Terminated
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
NCT01177540: Clinical Trial Phase 2 study, sponsored by Eisai.
NCT01177540 is a Phase 2 study that was terminated before completion, run by Eisai. The registered enrollment target is 25 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01177540, a Phase 2 study, was terminated before completion, sponsored by Eisai.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
Study Summary
The purpose of this study is to provide data on the activity of a standard daunorubicin, cytarabine, and etoposide (ADE) induction plus epigenetic priming with decitabine as assessed by standard measures of complete remission (CR), leukemia free survival (LFS) and overall survival (OS), as well as, on minimal residual disease (MRD). It will also provide necessary data on the safety and Pharmacokinetics (PK) of decitabine in pediatric patients that is currently unavailable.
Primary Outcome
Disease response measurements were based on bone marrow evaluations (biopsies, aspirates, or both) performed by local pathology laboratories and assessed by study investigators. A designation of CR required that the participant achieve a morphologic leukemia-free state and have an absolute neutrophil count (ANC) greater than 1000 per microliter (/mcL) and a platelet count greater than 100,000/mcL.
Interventions
- DRUG Decitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2011-03-03 |
| Est. Completion | 2013-07-19 |
| Phase | Phase 2 |
Why NCT01177540 stopped before completion
NCT01177540 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 1 intervention - of which Decitabine is the first listed.
NCT01177540 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01177540 about?
NCT01177540 is a clinical study titled "Efficacy and Safety of Decitabine as Epigenetic Priming With Induction Chemotherapy in Pediatric Acute Myelogenous Leukemia (AML) Subjects". The purpose of this study is to provide data on the activity of a standard daunorubicin, cytarabine, and etoposide (ADE) induction plus epigenetic priming with decitabine as assessed by standard measures of complete remission (CR), leukemia free survival (LFS) and overall survival (OS), as well as, ...
What is the current status of trial NCT01177540?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2011-03-03. Estimated completion is 2013-07-19.
What interventions are being tested in trial NCT01177540?
The interventions under investigation include: Decitabine (DRUG).
Who is sponsoring clinical trial NCT01177540?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01177540's enrollment target sits among peer trials
25 1719th of 2000 higher than 245 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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