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Glasdegib plus intensive or non-intensive chemotherapy for untreated acute myeloid leukemia: results from the randomized, phase 3 BRIGHT AML 1019 trial
- Source :
- Leukemia; 20230101, Issue: Preprints p1-10, 10p
- Publication Year :
- 2023
-
Abstract
- This is the primary report of the randomized, placebo-controlled phase 3 BRIGHT AML 1019 clinical trial of glasdegib in combination with intensive chemotherapy (cytarabine and daunorubicin) or non-intensive chemotherapy (azacitidine) in patients with untreated acute myeloid leukemia. Overall survival (primary endpoint) was similar between the glasdegib and placebo arms in the intensive (n= 404; hazard ratio [HR] 1.05; 95% confidence interval [CI]: 0.782–1.408; two-sided p= 0.749) and non-intensive (n= 325; HR 0.99; 95% CI: 0.768–1.289; two-sided p= 0.969) studies. The proportion of patients who experienced treatment-emergent adverse events was similar for glasdegib versus placebo (intensive: 99.0% vs. 98.5%; non-intensive: 99.4% vs. 98.8%). The most common treatment-emergent adverse events were nausea, febrile neutropenia, and anemia in the intensive study and anemia, constipation, and nausea in the non-intensive study. The addition of glasdegib to either cytarabine and daunorubicin or azacitidine did not significantly improve overall survival and the primary efficacy endpoint for the BRIGHT AML 1019 phase 3 trial was not met. Clinical trial registration:ClinicalTrials.gov: NCT03416179.
Details
- Language :
- English
- ISSN :
- 08876924 and 14765551
- Issue :
- Preprints
- Database :
- Supplemental Index
- Journal :
- Leukemia
- Publication Type :
- Periodical
- Accession number :
- ejs63889037
- Full Text :
- https://doi.org/10.1038/s41375-023-02001-z