Study design and patients
AML
AML
Among 134 patients who were randomized in the multicenter, randomized, double-blind, placebo-controlled phase II study (ClinicalTrials.gov: NCT01961882), one patient allocated to the OCV-501 group did not receive the study drug, and 28 patients enrolled from overseas institutions were excluded from this study. Of the 105 eligible patients, 52 were the OCV-501 group and 53 were the placebo group. At the end of the OCV-501 phase II trial, 58 of the 105 patients were alive and 47 had died. Among the 58 surviving patients, updated information was obtained from 52 patients and censored data at the end of the trial were used in the remaining 6 patients. The study procedure and assessment were described previously [Briefly, AML patients who were ≥ 60 years, achieved initial CR with one or two cycles of induction chemotherapy, finished consolidation, and were not eligible for transplantation were enrolled. Since binding of OCV-501 to HLA class II molecules can be expected in 83.8–98.8% of Japanese [