Study Evaluating the Addition of Amifostine (Ethyol®) to Idarubicin and Cytosine Arabinoside in Older Patients With Acute Myeloid Leukemia
Public ClinicalTrials.gov record NCT00086099. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase IB/II, Randomized, Open-Label, Multicenter Study Evaluating Whether the Addition of Amifostine (Ethyol®) Will Enable the Safe Increase in Dose Intensity of Idarubicin in Combination With Cytosine Arabinoside in Older Patients With Newly Diagnosed, Previously Untreated Acute Myeloid Leukemia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00086099
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 54 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 60 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 30, 2004
- Primary completion
- Nov 30, 2005
- Completion
- Jan 31, 2006
- Last update posted
- Jan 28, 2009
2004 – 2006
United States locations
- U.S. sites
- 15
- U.S. states
- 12
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Scripps Cancer Center | San Diego | California | 92121 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Cancer Care Center | New Albany | Indiana | 47150 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| Spectrum Health Hospitals-Cook Research Dept. (No longer recruiting) | Grand Rapids | Michigan | 49503 | — |
| Great Lakes Cancer Center Management Specialties | Grosse Point Woods | Michigan | 48236 | — |
| Cancer Management Specialists (No longer Recruiting) | Grosse Pointe Woods | Michigan | 48236 | — |
| St. Barnabas Health Care Center | Newark | New Jersey | 07112 | — |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | — |
| Wake Forest University School of Medicine | Winston-Salem | North Carolina | 27157-1082 | — |
| Cleveland Clinic Foundation-Hemoatology/Oncology | Cleveland | Ohio | 44195-001 | — |
| Thomas Jefferson University Medical College | Philadelphia | Pennsylvania | 19107 | — |
| Baptist Clinical Research Center | Memphis | Tennessee | 38120 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00086099, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 28, 2009 · Synced Sep 25, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00086099 live on ClinicalTrials.gov.