ArticleThe Lancet regional health. Western Pacific2026
Low-dose chidamide maintenance therapy following allogeneic hematopoietic cell transplantation in T-cell acute lymphoblastic leukemia or lymphomas: a phase II, open-label, multicenter, single-arm trial.
Article in The Lancet regional health. Western Pacific, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05991973 (A Phase ll, Multi-center, Single-arm Clinical Study of Low-dose Chidamide Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation for T-cell Acute Lymphoblastic Leukemia or T-cell Lymphomas), which is not on this map. Not yet cited in PubMed.
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A Phase ll, Multi-center, Single-arm Clinical Study of Low-dose Chidamide Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation for T-cell Acute Lymphoblastic Leukemia or T-cell Lymphomas
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Abstract
Background: 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). Given the immunomodulatory properties of histone deacetylase inhibitors, this phase II trial (NCT05991973) investigated chidamide maintenance to reduce post-transplant relapse risk for T-ALL/TCL. Methods: In this multicenter, open-label study, patients aged 14-70 years in remission after first allo-HCT received oral chidamide (10 mg twice weekly) for up to 96 weeks. The primary endpoint was 2-year relapse-free survival (RFS). Secondary endpoints included overall survival (OS), cumulative incidence of relapse (CIR), non-relapse mortality (NRM), chronic GVHD, and safety. Outcomes were also compared post hoc with a matched control cohort without maintenance therapy. Findings: Between July 2023 and August 2024, 44 patients were enrolled. At a median follow-up of 24.3 months (IQR 18.2-25.7), the 2-year RFS was 83.7% (95% CI 73.3%-95.6%). Secondary endpoints showed a 2-year OS of 89.6% (80.3%-100%), CIR of 11.8% (1.9%-21.7%), NRM of 4.5% (0%-10.7%), and chronic GVHD of 38.3% (23.0%-53.5%). Treatment-emergent adverse events were predominantly grade 1-2 and manageable. The most frequent events were leukopenia (5 [11%]), thrombocytopenia (5 [11%]) and nausea or vomiting (5 [11%]). Interpretation: Chidamide as maintenance could be a potential prophylactic strategy of relapse after allo-HCT for T-ALL/TCL, warranting further confirmation through phase III trials. Funding: National Key Research and Development Program of China; National Natural Science Foundation of China; Zhejiang Provincial Natural Science Foundation of China.
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