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NCT00086099 · ClinicalTrials.gov registry record · Phase 1
Study Evaluating the Addition of Amifostine (Ethyol®) to Idarubicin and Cytosine Arabinoside in Older Patients With Acute Myeloid Leukemia
A Phase 1 study, sponsored by MedImmune.
- Completed
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
NCT00086099: Completed Phase 1 study, sponsored by MedImmune.
NCT00086099 is a Phase 1 study that has completed, run by MedImmune. The registered enrollment target is 54 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00086099, a Phase 1 study, has completed, sponsored by MedImmune.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
Study Summary
The primary objectives of this study are: 1. To evaluate whether the addition of amifostine will allow for the safe administration of idarubicin at a dose of 21 mg/m² in combination with standard-dose ara-C in older patients with newly diagnosed, previously untreated acute myeloid leukemia (AML); and 2. To estimate the complete remission rate of induction therapy with amifostine, idarubicin (21 mg/m²), plus ara-C or induction therapy with idarubicin (12 mg/m²) plus ara-C in this patient population.
Interventions
- DRUG Idarubincin and Amufostine (Ethyol)
- DRUG Idarubincin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2004-07 |
| Est. Completion | 2006-02 |
| Phase | Phase 1 |
What the finished NCT00086099 record still lists
NCT00086099 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower).
The record links to 0 conditions, and to 2 interventions - of which Idarubincin and Amufostine (Ethyol) is the first listed.
NCT00086099 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00086099 about?
NCT00086099 is a clinical study titled "Study Evaluating the Addition of Amifostine (Ethyol®) to Idarubicin and Cytosine Arabinoside in Older Patients With Acute Myeloid Leukemia". The primary objectives of this study are: 1. To evaluate whether the addition of amifostine will allow for the safe administration of idarubicin at a dose of 21 mg/m² in combination with standard-dose ara-C in older patients with newly diagnosed, previously untreated acute myeloid leukemia (AML); a...
What is the current status of trial NCT00086099?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2004-07. Estimated completion is 2006-02.
What interventions are being tested in trial NCT00086099?
The interventions under investigation include: Idarubincin and Amufostine (Ethyol) (DRUG), Idarubincin (DRUG).
Who is sponsoring clinical trial NCT00086099?
This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00086099's enrollment target sits among peer trials
54 931st of 2000 higher than 1,053 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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