BRIGHT AML 1019 Trial to Study Glasdegib Plus Chemotherapy in Acute Myeloid Leukemia
Posted: Thursday, June 11, 2020
According to research published in Future Medicine, the BRIGHT AML 1019 study, including two independent phase III trials, seeks to determine the outcomes of the combination of glasdegib and chemotherapy in patients with untreated acute myeloid leukemia (AML). In phase I and II trials, the oral Hedgehog pathway inhibitor was found to be effective and well tolerated.
“On completion, the studies will provide substantial evidence that may be useful to support expanding the current registration of glasdegib to include the treatment of patients with AML in combination with ‘7 + 3’ chemotherapy regimen or with azacitidine,” concluded Jorge E. Cortes, MD, of the Georgia Cancer Center, Augusta University, and colleagues.
The BRIGHT AML 1019 includes an intensive chemotherapy study, with patients randomly assigned to receive a ‘7 + 3’ induction of cytarabine and daunorubicin plus 100 mg of oral glasdegib once daily or plus placebo. If necessary, a second induction of ‘7 + 3’ or ‘5 + 2’ may be administered. Inductions may continue for up to 2 years and will be followed by cytarabine monotherapy, hematopoietic stem cell transplantation, or both, as appropriate.
In the nonintensive study, patients will be randomly assigned to receive azacitidine plus 100 mg of oral glasdegib once daily or plus placebo, for a minimum of 6 cycles or until progressive disease or toxicity occurs. Hematopoietic stem cell transplantation may be performed when appropriate.
The primary objective of both studies is to determine whether treatment with glasdegib can improve outcomes over those with placebo in addition to combination chemotherapy for patients with AML. Although the main focus is overall survival, BRIGHT AML 1019 will also evaluate response rates, event-free survival outcomes, duration of response, fatigue scores, and overall safety profile. In the nonintensive trial, time to response will also be measured.
Disclosure: For full disclosures of the study authors, visit futuremedicine.com.