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NCT00425477 · ClinicalTrials.gov registry record · Phase 2
Bexarotene and GM-CSF in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia
A Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Completed
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
NCT00425477: Completed Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT00425477 is a Phase 2 study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 26 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00425477, a Phase 2 study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
Study Summary
RATIONALE: Bexarotene may help cancer or abnormal cells become more like normal cells, and to grow and spread more slowly. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving bexarotene together with GM-CSF may be an effective treatment for myelodysplastic syndrome (MDS) or acute myeloid leukemia. PURPOSE: This phase II trial is studying how well giving bexarotene together with GM-CSF works in treating patients with MDS or acute myeloid leukemia.
Primary Outcome
Response to treatment was assessed after two cycles, according to International Working Group (IWG) criteria.
Interventions
- OTHER flow cytometry
- GENETIC cytogenetic analysis
- BIOLOGICAL sargramostim
- GENETIC fluorescence in situ hybridization
- DRUG bexarotene
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2006-11 |
| Est. Completion | 2016-09-30 |
| Phase | Phase 2 |
What the finished NCT00425477 record still lists
NCT00425477 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 5 interventions - of which flow cytometry is the first listed.
NCT00425477 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00425477 about?
NCT00425477 is a clinical study titled "Bexarotene and GM-CSF in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia". RATIONALE: Bexarotene may help cancer or abnormal cells become more like normal cells, and to grow and spread more slowly. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving bexarotene together with GM-CSF may be an ef...
What is the current status of trial NCT00425477?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2006-11. Estimated completion is 2016-09-30.
What interventions are being tested in trial NCT00425477?
The interventions under investigation include: flow cytometry (OTHER), cytogenetic analysis (GENETIC), sargramostim (BIOLOGICAL), fluorescence in situ hybridization (GENETIC), bexarotene (DRUG).
Who is sponsoring clinical trial NCT00425477?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00425477's enrollment target sits among peer trials
26 1708th of 2000 higher than 282 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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