A Phase I/II Trial to Assess the Efficacy and Toxicity of ASTX727 (Oral Decitabine/Cedazuridine) for the Treatment of Hematological Neoplasms After Allogeneic Stem Cell Transplantation

Inclusion Criteria: * Diagnosis of AML and MDS according to World Health Organization (WHO) classification that underwent first or second allogeneic HSCT with either peripheral blood or bone marrow as the source of the hematopoietic stem cells. * Age 18 to 75 years old. * High risk patients defined per cohorts as below: * Cohort #1: AML and MDS patients in morphological remission with persistence or reappearance of MRD by flow cytometry or molecular after allogeneic stem cell transplantation who are beyond day 100 after allogeneic stem cell transplantation. * When MRD is detected by flow cytometry, disease level at or above the sensitivity level of the test will be required. * MRD level at or above 0.1%. * When MRD is detected by molecular testing, disease level at or above the sensitivity level of the test will be required. * The limit of detection is 0.01% * Cohort #2: High risk AML and MDS patients who are in complete remission morphologically with no evidence of minimal residual disease by flow cytometry or cytogenetic or molecular testing within 100 days after allogeneic stem cell transplantation. * MDS patients: * Moderate-high, high or very high-risk groups by International Prognostic Scoring System-Molecular (IPSS-M) classification if classification is available (58). * TP53 with biallelic mutations(49). * Therapy-related MDS(50). * Presence of mutation ASXL1, SRSF2, DNMT3A, RUNX1, U2AF1, TP53, EZH2, STAG2, CBL, NRAS, BCOR ((49, 51-54)) * Bone mar…