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 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 cali

Trial Details

NCT ID
NCT00801489
Phase
PHASE2
Sponsor
M.D. Anderson Cancer Center
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Cytarabine
  • Decitabine
  • Filgrastim-sndz
  • Fludarabine Phosphate
  • Gemtuzumab Ozogamicin
  • Idarubicin
Locations (sample)
  • Houston, Texas, United States|29.76328,-95.36327

Key Eligibility Criteria

  • Patients must have untreated AML, or high-risk myelodysplastic syndromes (MDS) (refractory anemia with excess blasts, \[RAEB\], or RAEB "in transfo…
  • Patients must provide written consent
  • Participants will not be excluded based on performance status; for patients with Eastern Cooperative Oncology Group (ECOG) performance status \>= t…
  • Patients with organ dysfunction will not be excluded from the study; for patients with evidence of organ dysfunction (creatinine \>= 1.5, cardiac e…

For full eligibility, visit ClinicalTrials.gov.

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