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

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to no maximum
• SexAll
• Healthy volunteersNo

You may be able to join if

• Patients must have untreated AML, or high-risk myelodysplastic syndromes (MDS) (refractory anemia with excess blasts, [RAEB], or RAEB "in transformation" [RAEB-t]) characterized by t(8;21), inv(16), or t(16;16); the presence of additional abnormalities is irrelevant
• Patients must provide written consent
• Participants will not be excluded based on performance status; for patients with Eastern Cooperative Oncology Group (ECOG) performance status >= to 3 the dosing schedule will be discussed with study chairman
• Patients with organ dysfunction will not be excluded from the study; for patients with evidence of organ dysfunction (creatinine >= 1.5, cardiac ejection fraction =< 50%, total bilirubin >=2 and aspartate aminotransferase [AST]/alanine aminotransferase [ALT] >= 3 times upper limit of normal [ULN]), dose adjustments/omissions will be made
• Up to one cycle of prior induction therapy will be permitted to include patients in whom presence of "good-risk" cytogenetics was initially missed; if the patient is in remission from induction therapy, he/she will receive post-remission therapy; if the patient is not in remission then he/she will receive induction therapy
• Patients of child bearing potential should practice effective methods of contraception

You cannot join if

• Pregnant and lactating females will be excluded

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

Treatments listed in the registry

• Cytarabine (Drug): Given IV
• Decitabine (Drug): Given IV
• Filgrastim-sndz (Biological): Given SC
• Fludarabine Phosphate (Drug): Given IV
• Gemtuzumab Ozogamicin (Drug): Given IV
• Idarubicin (Drug): Given IV
• Laboratory Biomarker Analysis (Other): Correlative studies

Na · Single Group · masking: None

Main goals

• Complete remission rate (Up to 2 years)
• Toxicity rate (Up to 2 years)

Planned enrollment: 270 (estimated).

• M D Anderson Cancer Center, Houston, Texas

Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT00801489

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Oct 6, 2026. Public record; not medical advice.