Multicenter phase 2 trial of low-dose chidamide maintenance following allo-HCT in T-cell acute lymphoblastic leukemia or lymphomas

Despite allogeneic hematopoietic cell transplantation (allo-HCT), relapse remains a leading cause of treatment failure for patients with T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphomas (TCL). A multicenter phase 2 trial in China evaluated low-dose chidamide maitenance to reduce post-transplant relapse risk for T-ALL/TCL. The study enrolled 44 patients aged14 to 70 years in remission after first allo-HCT. The patients received oral chidamide 10 mg twice weekly for up to 96 weeks. The primary endpoint was 2-year relapse-free survival (RFS) rate, with secondary endpoints 2-year rates of overall survival (OS), cumulative incidence of relapse (CIR), nonrelapse mortality (NRM), and chronic graft-versus-host disease (cGVHD). At a median follow-up of 24.3 months (IQR 18.2-25.7). the 2-year RFS rate was 83.7% (95% CI 73.3-95.6), while 2–year rates of OS, CIR, NRM, and cGVHD were 89.6% (80.3-100), 11.8% (1.9-21.7), 4.5% (0-10.7), and 38.3% (23.0-53.5). Treatment-emergent adverse events were predominantly grade 1-2 and manageable. The authors conclude that chidamide maintenance could be a potential prophylactic strategy of relapse after allo-HCT for T-ALL/TCL.