Glasdegib plus intensive/nonintensive chemotherapy in untreated acute myeloid leukemia: BRIGHT AML 1019 Phase III trials

Jorge E. Cortes, Hervé Dombret, Akil Merchant, Tetsuzo Tauchi, Christine G. Dirienzo, Barbara Sleight, Xiaoxi Zhang, Eric P. Leip, Naveed Shaik, Timothy Bell, Geoffrey Chan, Mikkael A. Sekeres

Research output: Contribution to journalArticle

Abstract

Glasdegib, an oral Hedgehog pathway inhibitor, has been associated with significantly improved survival when combined with low-dose cytarabine in patients with untreated acute myeloid leukemia (AML) who were unsuitable for intensive chemotherapy, when compared with low-dose cytarabine alone. BRIGHT AML 1019 (NCT03416179) comprises two independently powered Phase III, randomized (1:1), double-blind global trials evaluating oral glasdegib 100 mg once daily or placebo plus one of two standard chemotherapy regimens in adults with untreated AML. The intensive trial combines glasdegib/placebo with cytarabine and daunorubicin (7 + 3), while the nonintensive trial combines glasdegib/placebo with azacitidine. The primary end point of both studies is overall survival. Secondary end points include response, time to and duration of response, event-free survival, safety, patient-reported outcomes and pharmacokinetics. Trial registration number: ClinicalTrials.gov identifier: NCT0341617.

Original languageEnglish (US)
Pages (from-to)3531-3545
Number of pages15
JournalFuture Oncology
Volume15
Issue number31
DOIs
StatePublished - Jan 1 2019

Fingerprint

Cytarabine
Acute Myeloid Leukemia
Placebos
Drug Therapy
Azacitidine
Daunorubicin
Survival
Reaction Time
Disease-Free Survival
Pharmacokinetics
Safety

Keywords

  • acute myeloid leukemia
  • glasdegib
  • Hedgehog signaling pathway
  • intensive chemotherapy
  • myelodysplastic syndrome
  • nonintensive chemotherapy
  • smoothened inhibitor

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Glasdegib plus intensive/nonintensive chemotherapy in untreated acute myeloid leukemia : BRIGHT AML 1019 Phase III trials. / Cortes, Jorge E.; Dombret, Hervé; Merchant, Akil; Tauchi, Tetsuzo; Dirienzo, Christine G.; Sleight, Barbara; Zhang, Xiaoxi; Leip, Eric P.; Shaik, Naveed; Bell, Timothy; Chan, Geoffrey; Sekeres, Mikkael A.

In: Future Oncology, Vol. 15, No. 31, 01.01.2019, p. 3531-3545.

Research output: Contribution to journalArticle

Cortes, JE, Dombret, H, Merchant, A, Tauchi, T, Dirienzo, CG, Sleight, B, Zhang, X, Leip, EP, Shaik, N, Bell, T, Chan, G & Sekeres, MA 2019, 'Glasdegib plus intensive/nonintensive chemotherapy in untreated acute myeloid leukemia: BRIGHT AML 1019 Phase III trials', Future Oncology, vol. 15, no. 31, pp. 3531-3545. https://doi.org/10.2217/fon-2019-0373
Cortes, Jorge E. ; Dombret, Hervé ; Merchant, Akil ; Tauchi, Tetsuzo ; Dirienzo, Christine G. ; Sleight, Barbara ; Zhang, Xiaoxi ; Leip, Eric P. ; Shaik, Naveed ; Bell, Timothy ; Chan, Geoffrey ; Sekeres, Mikkael A. / Glasdegib plus intensive/nonintensive chemotherapy in untreated acute myeloid leukemia : BRIGHT AML 1019 Phase III trials. In: Future Oncology. 2019 ; Vol. 15, No. 31. pp. 3531-3545.
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