A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia
Summary
Glasdegib is being studied in combination with azacitidine for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy (Non-intensive AML population). Glasdegib is being studied in combination with cytarabine and daunorubicin for the treatment of adult patients with previously untreated acute myeloid leukemia (Intensive AML population).
Timeline
- Start
- 2018-04-20
- Primary completion
- 2020-06-05
- Completion
- 2022-01-17
Outcome
Missed primary endpoint
registry analysis (superiority test); Intensive Study: Glasdegib + Cytarabine + Daunorubicin vs Intensive Study: Placebo + Cytarabine + Daunorubicin; p = 0.6579; Hazard Ratio (HR) 1.08 (95% CI 0.755 to 1.532); Log Rank NCT03416179 ↗
registry analysis (superiority test); Non-intensive Study: Glasdegib + Azacitidine vs Non-intensive Study: Placebo + Azacitidine; p = 0.5955; Hazard Ratio (HR) 1.04 (95% CI 0.775 to 1.388); Log Rank NCT03416179 ↗
Publications
- Sekeres MA, Montesinos P, Novak J, Wang J, Jeyakumar D, Tomlinson B, Mayer J, Jou E, Robak T, Taussig DC, Dombret H, Merchant A, Shaik N, O'Brien T, Roh W, Liu X, Ma W, DiRienzo CG, Chan G, Cortes JE. Glasdegib plus intensive or non-intensive chemotherapy for untreated acute myeloid leukemia: results from the randomized, phase 3 BRIGHT AML 1019 trial. Leukemia. 2023 Oct;37(10):2017-2026. doi: 10.1038/s41375-023-02001-z. Epub 2023 Aug 21.
- Cortes JE, Dombret H, Merchant A, Tauchi T, DiRienzo CG, Sleight B, Zhang X, Leip EP, Shaik N, Bell T, Chan G, Sekeres MA. Glasdegib plus intensive/nonintensive chemotherapy in untreated acute myeloid leukemia: BRIGHT AML 1019 Phase III trials. Future Oncol. 2019 Nov;15(31):3531-3545. doi: 10.2217/fon-2019-0373. Epub 2019 Sep 13.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Glasdegib | Small molecule | 100 mg | Oral |
| Background | Azacitidine | Other / unclassified | 75 mg/m2 | Subcutaneous |
| Background | Cytarabine | Small molecule | 100 mg/m2 | Intravenous |
| Background | Cytarabine | Small molecule | 1 g | Intravenous |
| Background | Cytarabine | Small molecule | 3 g | Intravenous |
| Background | Daunorubicin | Small molecule | 60 mg/m2 | — |