Fludarabine Phosphate, Cytarabine, Filgrastim-sndz, Gemtuzumab Ozogamicin, and Idarubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
Public ClinicalTrials.gov record NCT00801489. 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 2 Study of Fludarabine, Cytarabine, Filgrastim-sndz,Gemtuzumab Ozogamicin and Idarubicin in Newly Diagnosed Core Binding Factor Associated Acute Myelogenous Leukemia
Study identification
- NCT ID
- NCT00801489
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- M.D. Anderson Cancer Center
- Other
- Enrollment
- 270 participants
Conditions and interventions
Conditions
- Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11
- Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11
- Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1
- High Risk Myelodysplastic Syndrome
- Inv(16)
- Myelodysplastic Syndrome With Excess Blasts
- Untreated Adult Acute Myeloid Leukemia
- de Novo Myelodysplastic Syndrome
- t(16;16)
- t(8;21)
Interventions
- Cytarabine Drug
- Decitabine Drug
- Filgrastim-sndz Biological
- Fludarabine Phosphate Drug
- Gemtuzumab Ozogamicin Drug
- Idarubicin Drug
- Laboratory Biomarker Analysis Other
Drug · Biological · Other
Eligibility (public fields only)
- Age range
- 18 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
- Apr 3, 2007
- Primary completion
- Oct 10, 2028
- Completion
- Oct 10, 2028
- Last update posted
- Mar 29, 2026
2007 – 2028
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00801489, 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 Mar 29, 2026 · Synced May 5, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00801489 live on ClinicalTrials.gov.