TY - JOUR
T1 - Glasdegib plus intensive/nonintensive chemotherapy in untreated acute myeloid leukemia
T2 - BRIGHT AML 1019 Phase III trials
AU - Cortes, Jorge E.
AU - Dombret, Hervé
AU - Merchant, Akil
AU - Tauchi, Tetsuzo
AU - Dirienzo, Christine G.
AU - Sleight, Barbara
AU - Zhang, Xiaoxi
AU - Leip, Eric P.
AU - Shaik, Naveed
AU - Bell, Timothy
AU - Chan, Geoffrey
AU - Sekeres, Mikkael A.
N1 - Publisher Copyright:
© 2019 Pfizer Inc.
PY - 2019
Y1 - 2019
N2 - 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.
AB - 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.
KW - Hedgehog signaling pathway
KW - acute myeloid leukemia
KW - glasdegib
KW - intensive chemotherapy
KW - myelodysplastic syndrome
KW - nonintensive chemotherapy
KW - smoothened inhibitor
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UR - http://www.scopus.com/inward/citedby.url?scp=85074380285&partnerID=8YFLogxK
U2 - 10.2217/fon-2019-0373
DO - 10.2217/fon-2019-0373
M3 - Article
C2 - 31516032
AN - SCOPUS:85074380285
SN - 1479-6694
VL - 15
SP - 3531
EP - 3545
JO - Future Oncology
JF - Future Oncology
IS - 31
ER -
