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NCT01550224 · ClinicalTrials.gov registry record · Phase 2
Temozolomide Plus Vorinostat in Relapse/Refractory Acute Myeloid Leukemia (AML)
A Phase 2 study, sponsored by Steven E. Coutre.
- Completed
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
NCT01550224: Completed Phase 2 study, sponsored by Steven E. Coutre.
NCT01550224 is a Phase 2 study that has completed, run by Steven E. Coutre. The registered enrollment target is 23 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01550224, a Phase 2 study, has completed, sponsored by Steven E. Coutre.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 23 participants
- Enrollment target
Study Summary
The purpose of the study is to first determine if temozolomide plus vorinostat in combination can control relapsed or refractory acute myeloid leukemia (AML) and determine if this combination can be safely taken. The study will look at the side effects of the Temozolomide plus Vorinostat in combination and whether the treatment schedule is tolerated.
Primary Outcome
This study evaluates the clinical efficacy of temozolomide + vorinostat as administered to Groups 1 and 2, assessed as the rate of complete remission \[CR, aka morphologic complete remission (mCR)\], defined as the morphologic leukemia-free state (MLFS), WITH absolute neutrophil count (ANC) ≥ 1,000/µL AND platelets (PLT) ≥ 100,000/µL. The outcome is reported as the percentage without dispersion of participants in Groups 1 and 2 that demonstrated CR. CR is defined as all of the following. MLFS =
Interventions
- DRUG Temozolomide
- DRUG Vorinostat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2013-05-01 |
| Est. Completion | 2014-11-17 |
| Phase | Phase 2 |
What the finished NCT01550224 record still lists
NCT01550224 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Temozolomide is the first listed.
NCT01550224 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01550224 about?
NCT01550224 is a clinical study titled "Temozolomide Plus Vorinostat in Relapse/Refractory Acute Myeloid Leukemia (AML)". The purpose of the study is to first determine if temozolomide plus vorinostat in combination can control relapsed or refractory acute myeloid leukemia (AML) and determine if this combination can be safely taken. The study will look at the side effects of the Temozolomide plus Vorinostat in combinat...
What is the current status of trial NCT01550224?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2013-05-01. Estimated completion is 2014-11-17.
What interventions are being tested in trial NCT01550224?
The interventions under investigation include: Temozolomide (DRUG), Vorinostat (DRUG).
Who is sponsoring clinical trial NCT01550224?
This trial is sponsored by Steven E. Coutre, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01550224's enrollment target sits among peer trials
23 1784th of 2000 higher than 211 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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