Phase 3b Study of Venetoclax and Azacitidine or Decitabine in Outpatient Setting for Acute Myeloid Leukemia
Key Findings:
Venetoclax combined with azacitidine or decitabine is approved for treating newly diagnosed acute myeloid leukemia (ND AML) in patients unable to undergo intensive chemotherapy.
This study assessed the effectiveness and safety of this combination in a community-based outpatient setting in the United States.
Patients received venetoclax with azacitidine or decitabine for up to 6 cycles, with a median time on study of 18.3 weeks.
The best response rate for complete remission was 66.7%, and the overall transfusion independence rate for red blood cells and platelets was 55.0%.
Key adverse events included nausea, anemia, thrombocytopenia, neutropenia, and white blood cell count decrease.
Two cases of tumor lysis syndrome (TLS) were identified and managed with close monitoring, allowing the patients to continue the study.
Clinical Trials Registration:
This study is registered at ClinicalTrials.gov with the identification number NCT03941964.
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