biostudies-literatureKantarjian HMCyclacel Limited, Dundee, Scotland, UKNCI NIH HHS4421-4431https://www.ebi.ac.uk/biostudies/studies/S-EPMC9523989biostudies-literatureUnknown127(23)<h4>Background</h4>Acute myeloid leukemia (AML) is fatal in elderly patients who are unfit for standard induction chemotherapy. The objective of this study was to evaluate the survival benefit of administering sapacitabine, an oral nucleoside analogue, in alternating cycles with decitabine, a low-intensity therapy, to elderly patients with newly diagnosed AML.<h4>Methods</h4>This randomized, open-label, phase 3 study (SEAMLESS) was conducted at 87 sites in 11 countries. Patients aged ≥70 years who were not candidates for or chose not to receive standard induction chemotherapy were randomized 1:1 to arm A (decitabine in alternating cycles with sapacitabine) received 1-hour intravenous infusions of decitabine 20 mg/m² once daily for 5 consecutive days every 8 weeks (first cycle anCancerResults of a randomized phase 3 study of oral sapacitabine in elderly patients with newly diagnosed acute myeloid leukemia (SEAMLESS).PMC9523989P30 CA008748P50 CA100632Schiller GJChiao JHManess LJBuyse MEGoldberg SLVenugopal PKantarjian HMButrym ALuger SMBaer MRKadia TMSeiter KGautier MThomas XGBegna KHBerman EAltman JKStrickland SASekeres MASolomon SRMontesinos PQuick DPRizzieri DAClaxton DFGaur RArellano MLGaidano GRavandi FfalseResults of a randomized phase 3 study of oral sapacitabine in elderly patients with newly diagnosed acute myeloid leukemia (SEAMLESS).<h4>Background</h4>Acute myeloid leukemia (AML) is fatal in elderly patients who are unfit for standard induction chemotherapy. The objective of this study was to evaluate the survival benefit of administering sapacitabine, an oral nucleoside analogue, in alternating cycles with decitabine, a low-intensity therapy, to elderly patients with newly diagnosed AML.<h4>Methods</h4>This randomized, open-label, phase 3 study (SEAMLESS) was conducted at 87 sites in 11 countries. Patients aged ≥70 years who were not candidates for or chose not to receive standard induction chemotherapy were randomized 1:1 to arm A (decitabine in alternating cycles with sapacitabine) received 1-hour intravenous infusions of decitabine 20 mg/m² once daily for 5 consecutive days every 8 weeks (first cycle an2021-01-01T00:00:00Z2021 Dec2025-04-19T15:40:57.272Z2025-04-19T15:40:57.272ZS-EPMC95239893442453010.1002/cncr.33828