Phase II Study of Chidamide as Maintenance Therapy After Stem Cell Transplant in Adults With Intermediate or High-Risk AML

What this Trial Is About

This research aims to evaluate the use of Chidamide as a maintenance therapy in patients with high-risk acute myeloid leukemia AML who have undergone stem cell transplantation. The study is a Phase II clinical trial designed to assess the impact of this treatment on recurrence-free survival, overall survival, and the duration of complete remission. It also examines the safety and tolerability of Chidamide and its effects on minimal residual disease in these patients. Participants in the trial are randomly assigned to one of two groups an experimental group receiving Chidamide or an observation group without intervention. The Chidamide treatment involves taking 10 mg orally once daily for the first five days of each week, followed by two days off, in 28-day cycles. Treatment may continue for up to 24 months, with dose adjustments allowed to manage side effects. Patients may stay in the study even if relapse occurs, depending on clinical judgment. During the study, patients will be closely monitored through regular assessments including survival rates, response duration, and treatment-related side effects over a two-year period. The study also tracks changes in minimal residual disease and monitors safety using standard criteria. Participants will be followed until disease progression, unacceptable toxicity, or withdrawal from the study, ensuring comprehensive evaluation of the treatments effects.

Post-transplantation Maintenance Therapy With Cidabenamide in Patients With Intermediate/High-risk AML