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NCT00387647 · ClinicalTrials.gov registry record · Phase 2
Maintenance Azacitidine in Elderly Patients With Acute Myeloid Leukemia (AML) in CR After Induction Chemotherapy
A Phase 2 study of Leukemia, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
- 2
- Study locations
NCT00387647: Completed Phase 2 study of Leukemia, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT00387647 is a Phase 2 study of Leukemia that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 24 participants, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (95% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00387647, a Phase 2 study of Leukemia, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to find out if patients older than 60, with acute myeloid leukemia, who are in complete remission following initial chemotherapy, will live longer and have a lower rate of leukemia relapse when treated with azacitidine.
Primary Outcome
The primary efficacy variable is disease free survival measured at one year, which is the percentage of patients who remain alive and disease free one year after the confirmation of remission by bone marrow biopsy. Relapse is defined by a bone marrow specimen with \>5% blasts or the presence of Auer rods.
Conditions Studied
Interventions
- DRUG Azacitidine
Study Locations (2)
Florida
- H. Lee Moffitt Cancer Center and Research Institute - Tampa
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2006-08 |
| Est. Completion | 2014-08 |
| Phase | Phase 2 |
What the finished NCT00387647 record still lists
NCT00387647 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 487-participant average among 233 other Leukemia trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Leukemia appearing as the primary indexed condition, and to 1 intervention - of which Azacitidine is the first listed.
NCT00387647 reports a single indexed study location in Florida, North Carolina.
Frequently Asked Questions
What is clinical trial NCT00387647 about?
NCT00387647 is a clinical study titled "Maintenance Azacitidine in Elderly Patients With Acute Myeloid Leukemia (AML) in CR After Induction Chemotherapy". The purpose of this study is to find out if patients older than 60, with acute myeloid leukemia, who are in complete remission following initial chemotherapy, will live longer and have a lower rate of leukemia relapse when treated with azacitidine.
What is the current status of trial NCT00387647?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2006-08. Estimated completion is 2014-08.
What conditions does trial NCT00387647 study?
This clinical trial studies the following conditions: Leukemia.
What interventions are being tested in trial NCT00387647?
The interventions under investigation include: Azacitidine (DRUG).
Who is sponsoring clinical trial NCT00387647?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00387647 being conducted?
This trial has 2 study locations across Florida, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00387647's enrollment target sits among peer trials
24 173rd of 233 higher than 59 of 233 other Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Leukemia 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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