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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 is a Phase 1 study that has completed, run by MedImmune. The registered enrollment target is 54 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00086099
The ClinicalTrials.gov registry entry for NCT00086099 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MedImmune, which has 210 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Idarubincin and Amufostine (Ethyol) is the first listed.
NCT00086099 reports 0 study locations.
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.
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