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NCT01130688 · ClinicalTrials.gov registry record · Phase 1
Safety of Zileuton (Zyflo) in Combination With Imatinib Mesylate (Gleevec) in CML.
A Phase 1 study, sponsored by University of Massachusetts, Worcester.
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT01130688: Clinical Trial Phase 1 study, sponsored by University of Massachusetts, Worcester.
NCT01130688 is a Phase 1 study that was terminated before completion, run by University of Massachusetts, Worcester. The registered enrollment target is 2 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01130688, a Phase 1 study, was terminated before completion, sponsored by University of Massachusetts, Worcester.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
The leukemic stem cells (LSCs) are cells that self- renew and give rise to leukemia. Eradication of LSC is required for cure. In chronic myelogenous leukemia (CML) LSCs are not eradicated by imatinib (Gleevec) alone. Recent discovery by Dr. Shaoguang Li at University of Massachusetts indicates that the LSCs can be targeted by a new drug zileuton (Chen et al. Nature Genetics 2009; 41:783-792). Zileuton (approved for asthma) will be tested in a combination with Gleevec. This combination has not been used previously to treat leukemia. This is a Phase I study. The goal of this research is to evaluate the safety of the standard anti-cancer drug imatinib and experimental drug zileuton.
Interventions
- DRUG Zileuton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2010-01 |
| Est. Completion | 2014-12 |
| Phase | Phase 1 |
Why NCT01130688 stopped before completion
NCT01130688 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Zileuton is the first listed.
NCT01130688 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01130688 about?
NCT01130688 is a clinical study titled "Safety of Zileuton (Zyflo) in Combination With Imatinib Mesylate (Gleevec) in CML.". The leukemic stem cells (LSCs) are cells that self- renew and give rise to leukemia. Eradication of LSC is required for cure. In chronic myelogenous leukemia (CML) LSCs are not eradicated by imatinib (Gleevec) alone. Recent discovery by Dr. Shaoguang Li at University of Massachusetts indicates that ...
What is the current status of trial NCT01130688?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2010-01. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01130688?
The interventions under investigation include: Zileuton (DRUG).
Who is sponsoring clinical trial NCT01130688?
This trial is sponsored by University of Massachusetts, Worcester, which has 240 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01130688's enrollment target sits among peer trials
2 2000th of 2000 the lowest 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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