Allogeneic Stem Cell Transplantation Clinical Trial
Official title:
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
To learn if ASTX727 given alone or in combination with donor lymphocyte infusion (DLI) can help to control certain types of hematological neoplasms (blood-based cancers) after a stem cell transplant.
Primary Objectives - To determine the safety and toxicity of ASTX727 with or without donor lymphocyte infusion (type, frequency, severity of adverse events [AEs] and relationship of AEs to ASTX727) in the study population (cohort #1 and cohort #2). - To estimate the complete response (CR) rate of ASTX727 with or without donor lymphocyte infusion (DLI) for the eradication of minimal residual disease (MRD) in participants with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), after hematopoietic stem cell transplantation (cohort #1). - Estimate relapse-free survival (RFS) with the use of ASTX727 as maintenance therapy in participants with high-risk AML and MDS after study entry following hematopoietic stem cell transplantation (cohort #2). Secondary Objectives - Participants with creatinine clearance 40-60 cc/min at enrollment will be observed and reported for safety and toxicity separately. - To determine the overall response and response duration in cohort #1, in participants with MRD detected in the post-transplant setting. - Duration of remission after study entry following allogeneic stem cell transplant for cohort #2. - To determine incidence of acute and chronic graft versus host disease (GvHD) - To evaluate overall survival (OS). Exploratory Objective - To investigate possible relationships between protein and gene expression signatures/mutation profile and DNA methylation in predicting relapse-free survival time to the ASTX727. - To gain insight into clinically relevant genomic factors influencing transplant outcomes, especially into the mechanism of relapse after transplant. - To characterize the composition of different T-cell subsets, and to determine how those correlate with each other and with transplant outcomes. ;
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