Fludarabine Phosphate, Cytarabine, Filgrastim-sndz, Gemtuzumab Ozogamicin, and Idarubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the 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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Nowo rozpoznana ostra białaczka szpikowa lub zaawansowany zespół mielodysplastyczny z pewnymi zmianami genetycznymi
- •Brak wcześniejszego leczenia chemioterapią, lub maksymalnie jeden cykl
- •Zgoda pacjenta na uczestnictwo w badaniu
- •Pacjenci w złym ogólnym stanie również mogą uczestniczyć (dawki mogą być zmieniane)
- •Pacjenci z problemami wątroby lub nerek mogą uczestniczyć (mogą być zmieniane dawki)
- •Kobiety w wieku rozrodczym powinny stosować skuteczną antykoncepcję
✗ Disqualifies
- •Ciężarne lub karmiące matki
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- October 7, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
M D Anderson Cancer Center
Houston, United States
Trial contact
Jayastu Senapati
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/19/2026.
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