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Study identifier: NCT00801489 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: 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  ·  Sponsor: M.D. Anderson Cancer Center

PhasePhase 2
Planned participants270
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this 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.

This description comes directly from the study's public registry record.

Talk to the study team

Gautam Borthakur  ·  713-563-1586  ·  gborthak@mdanderson.org

Always discuss trial participation with your own doctor first.

Locations (1)

M D Anderson Cancer CenterHouston, Texas, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT00801489