Glasdegib in combination with cytarabine and daunorubicin in patients with AML or high-risk MDS: Phase 2 study results.

ABSTRACT: Glasdegib is a Hedgehog pathway inhibitor. This ongoing, open-label, phase 2 study (NCT01546038) evaluated glasdegib plus cytarabine/daunorubicin in patients with untreated acute myeloid leukemia (AML) or high-risk myelodysplastic syndromes (MDS). Patients received glasdegib 100 mg orally, once daily in continuous 28-day cycles from day -3, with intravenous cytarabine 100 mg/m² on days 1-7 and daunorubicin 60 mg/m² on days 1-3. Patients in remission then received consolidation therapy (2-4 cycles of cytarabine 1 g/m² twice daily on days 1, 3, 5 of each cycle), followed by maintenance glasdegib (maximum 6 cycles). Primary endpoint was complete remission (CR) in patients aged ≥55 years. Secondary endpoints included overall survival (OS), safety and outcome by

SUBMITTER: Cortes JE 

PROVIDER: S-EPMC6221102 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature