About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Pregnant and lactating females will be excluded
Trial design
Single group
Treatments tested in this trial
Cytarabine
DrugGiven IV
Decitabine
DrugGiven IV
Filgrastim-sndz
Biological/VaccineGiven SC
Fludarabine Phosphate
DrugGiven IV
Gemtuzumab Ozogamicin
DrugGiven IV
Idarubicin
DrugGiven IV
Laboratory Biomarker Analysis
Other interventionCorrelative studies
Treatment groups
Trial outcomes
Primary outcomes
Complete remission rate
Toxicity rate
Sponsors and contacts
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M.D. Anderson Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator