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

A Phase 2 Study of Fludarabine, Cytarabine, Filgrastim-sndz,Gemtuzumab Ozogamicin and Idarubicin in Newly Diagnosed Core Binding Factor Associated Acute Myelogenous Leukemia

Who can join

Ages 18 and older · All sexes

Inclusion Criteria:

* 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

Exclusion Criteria:

* Pregnant and lactating females will be excluded

About the study

This phase II trial studies the side effects and how well fludarabine phosphate, cytarabine, filgrastim-sndz, gemtuzumab ozogamicin, and idarubicin hydrochloride work in treating patients with newly diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome. Drugs used in chemotherapy, such as fludarabine phosphate, cytarabine, and idarubicin hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Gemtuzumab ozogamicin is a monoclonal antibody, called gemtuzumab, linked to a antitumor drug, called calicheamicin. Gemtuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD33 receptors, and delivers calicheamicin to kill them. Colony-stimulating factors, such as filgrastim-sndz, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving fludarabine phosphate, cytarabine, filgrastim-sndz, gemtuzumab ozogamicin, and idarubicin hydrochloride may kill more cancer cells.

What is being tested

• Cytarabine (drug)
• Decitabine (drug)
• Filgrastim-sndz (biological)
• Fludarabine Phosphate (drug)
• Gemtuzumab Ozogamicin (drug)
• Idarubicin (drug)

Sponsor: M.D. Anderson Cancer Center · Participants: 270 · Started: Apr 4, 2007

Contact the study team

• Gautam Borthakur · Phone: 713-563-1586

Official record on ClinicalTrials.gov — NCT00801489

Locations in the U.S.

Conditions

• with Excess of Blasts Refractory Anemia

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.