TY - T1 - Adjunctive Volasertib in Patients With Acute Myeloid Leukemia not Eligible for Standard Induction Therapy : A Randomized, Phase 3 Trial SN - / UR - http://hdl.handle.net/10138/334645 T3 - A1 - Dohner, Hartmut; Symeonidis, Argiris; Deeren, Dries; Demeter, Judit; Sanz, Miguel A.; Anagnostopoulos, Achilles; Esteve, Jordi; Fiedler, Walter; Porkka, Kimmo; Kim, Hee-Je; Lee, Je-Hwan; Usuki, Kensuke; D'Ardia, Stefano; Won Jung, Chul; Salamero, Olga; Horst, Heinz-August; Recher, Christian; Rousselot, Philippe; Sandhu, Irwindeep; Theunissen, Koen; Thol, Felicitas; Dohner, Konstanze; Teleanu, Veronica; DeAngelo, Daniel J.; Naoe, Tomoki; Sekeres, Mikkael A.; Belsack, Valerie; Ge, Miaomiao; Taube, Tillmann; Ottmann, Oliver G. A2 - PB - Y1 - 2021 LA - eng AB - In this phase 3 trial, older patients with acute myeloid leukemia ineligible for intensive chemotherapy were randomized 2:1 to receive the polo-like kinase inhibitor, volasertib (V; 350 mg intravenous on days 1 and 15 in 4-wk cycles), combined with low-dose cytarabine (LDAC; 20 mg subcutaneous, twice daily, days 1-10; n = 444), or LDAC plus placebo (P; n = 222). Primary endpoint was objective response rate (ORR); key secondary endpoint was overall survival (OS). Primary ORR analysis at recruitme... VO - IS - SP - OP - KW - KINASE INHIBITOR VOLASERTIB; LOW-DOSE CYTARABINE; BI 6727; OPEN-LABEL; RECOMMENDATIONS; AZACITIDINE; DECITABINE; MANAGEMENT; VENETOCLAX; DIAGNOSIS; 3122 Cancers N1 - PP - ER -