Venetoclax With Combination Chemotherapy in Treating Patients With Newly Diagnosed or Relapsed or Refractory Acute Myeloid Leukemia

This phase Ib/II trial studies the best dose and side effects of venetoclax and how well it works when given with combination chemotherapy in treating patients with newly diagnosed acute myeloid leukemia or acute myeloid leukemia that has come back or does not respond to treatment. Venetoclax may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fludarabine, cytarabine, filgrastim and idarubicin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by s

Trial Details

NCT ID
NCT03214562
Phase
PHASE1 / PHASE2
Sponsor
M.D. Anderson Cancer Center
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Cytarabine
  • Filgrastim
  • Fludarabine
  • Idarubicin
  • Pegfilgrastim
  • Venetoclax
Locations (sample)
  • Houston, Texas, United States|29.76328,-95.36327

Key Eligibility Criteria

  • Diagnosis of AML by World Health Organization (WHO) criteria. Patients with high risk myelodysplastic syndrome (MDS) as defined by the presence of …
  • Patients older than 65 who are deemed fit to receive intensive chemotherapy by the treating physician will be eligible after discussion with the pr…
  • Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2
  • Creatinine clearance \>= 30 mL/min based on the Cockcroft-Gault equation

For full eligibility, visit ClinicalTrials.gov.

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