# Fludarabine Phosphate, Cytarabine, Filgrastim-sndz, Gemtuzumab Ozogamicin, and Idarubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

> **NCT00801489** · PHASE2 · RECRUITING · sponsor: **M.D. Anderson Cancer Center** · enrollment: 270 (estimated)

## Conditions studied

- 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
- de Novo Myelodysplastic Syndrome
- High Risk Myelodysplastic Syndrome
- Inv(16)
- Myelodysplastic Syndrome With Excess Blasts
- t(16;16)
- t(8;21)
- Untreated Adult Acute Myeloid Leukemia

## Interventions

- **DRUG:** Cytarabine
- **DRUG:** Decitabine
- **BIOLOGICAL:** Filgrastim-sndz
- **DRUG:** Fludarabine Phosphate
- **DRUG:** Gemtuzumab Ozogamicin
- **DRUG:** Idarubicin
- **OTHER:** Laboratory Biomarker Analysis

## Key facts

- **NCT ID:** NCT00801489
- **Lead sponsor:** M.D. Anderson Cancer Center
- **Sponsor class:** OTHER
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2007-04-04
- **Primary completion:** 2028-10-11
- **Final completion:** 2028-10-11
- **Target enrollment:** 270 (ESTIMATED)
- **Last updated:** 2026-03-30

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00801489

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00801489, "Fludarabine Phosphate, Cytarabine, Filgrastim-sndz, Gemtuzumab Ozogamicin, and Idarubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome". Retrieved via AI Analytics 2026-06-01 from https://api.ai-analytics.org/clinical/NCT00801489. Licensed CC0.

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