B1371019
A randomized (1:1), double-blind, Multi-center, placebo controlled study evaluating intensive chemotherapy with or without glasdegib (PF-04449913) or azacitidine (AZA) with or without glasdegib in patients with previously untreated acute myeloid leukemia
Study treatment
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Glasdegib
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placebo
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| Intensive chemotherapy
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cytarabine 100 mg/m² intravenous for 7 days by continuous infusion and daunorubicin 60 mg/m² for 3 days + daily glasdegib (100 mg oral) beginning on Day 1 and is to continue up to 2 years post randomization
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cytarabine 100 mg/m² intravenous for 7 days by continuous infusion and daunorubicin 60 mg/m² for 3 days + daily matching placebo (100 mg oral) beginning on Day 1 and is to continue up to 2 years post randomization
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| Non-intensive chemotherapy
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Azacitidine (75 mg/m², subcutanous or intravenous) daily for 7 days, in 28 day cycles + daily glasdegib (100 mg oral)
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Azacitidine (75 mg/m², subcutanous or intravenous) daily for 7 days, in 28 day cycles + daily matching placebo (oral)
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Inclusion criteria
- Diagnosis of untreated AML according to WHO 2016 classification
- 18 years of age
- adequate organ function
- QTc interval 470 msec using the Fridericia correction
Exclusion criteria
- Acute promyelocytic leukemia (APL) and APL RARA
- AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality
- Subjects with known active CNS leukemia
- Subjects known to be refractory to platelet or packed red cell transfusions
Participating sites
- AZ Sint-Jan Brugge
- UZ Brussel