Study population
toxicity, chronic myeloid leukemia, AML
DISEASE PROGRESSION, ADVERSE EVENTS, MYELODYSPLASTIC SYNDROME, BLAST CRISIS, GRAFT-VERSUS-HOST DISEASE, AML, CENTRAL NERVOUS SYSTEM LEUKEMIA, ACUTE PROMYELOCYTIC LEUKEMIA, CHRONIC MYELOID LEUKEMIA, REMISSION, ONCOLOGY
This study included patients ≥ 20 years old with R/R AML and those with a history of myelodysplastic syndrome. Also eligible were patients who failed to achieve remission with at least one cycle of prior induction therapy, who relapsed after achieving remission with prior therapy, could not achieve persistent remission with standard treatment, had failed to complete potentially curative treatment, or had no treatment options with expected therapeutic efficacy. The Eastern Cooperative Oncology Group performance status (ECOG PS) scores for these patients ranged from 0 to 2. This study excluded those with a diagnosis of acute promyelocytic leukemia, chronic myeloid leukemia in a blast crisis (positive for a breakpoint cluster region-c-Abelson [BCR-ABL] fusion gene), history of or concurrent central nervous system leukemia, history of hematopoietic stem cell transplant within 60 days before the initiation of this study, graft-versus-host disease, and grade ≥ 2 clinically significant or irreversible nonhematological toxicity related to transplantation.Although confirmation of Patients were disqualified from the study if an apparent disease progression was noted, adverse events (AEs) made it difficult to continue milademetan treatment, consent was withdrawn, milademetan was administered on < 75% of the specified dosing days, or the investigators deemed it inappropriate to continue the study. In the case of the latter, the investigators always recorded the date and reasons for discontinuation.