This study evaluates whether chidamide maintenance therapy can effectively reduce the risk of relapse after allogeneic hematopoietic stem cell transplantation (allo-HSCT) in patients with high-risk T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma (T-ALL/LBL). Chidamide is an oral selective histone deacetylase inhibitor (HDACi) with dual anti-tumor and immunomodulatory effects.
Participants will be randomized in a 1:1 ratio to receive either chidamide maintenance for up to 24 months or standard follow-up without maintenance. The primary endpoint is relapse-free survival (RFS). Key secondary endpoints include cumulative incidence of relapse (CIR), overall survival (OS), non-relapse mortality (NRM), incidence and severity of graft-versus-host disease (GVHD), safety profile, and patient-reported outcomes (PROs).
This multicenter, open-label, randomized controlled trial aims to provide high-level evidence on the efficacy and safety of chidamide as a post-transplant maintenance strategy. Approximately 132 patients will be enrolled across 6 transplant centers in China.
Age 14-70 years (inclusive).
Confirmed diagnosis of T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL) according to the 2016 WHO classification, with an early T-cell precursor (ETP) phenotype defined by immunophenotypic criteria: CD1a-, CD8-, CD5 weak, with expression of one or more myeloid/stem cell markers (e.g., CD34, CD117, HLA-DR, CD13, CD33, CD11b, or CD65).
Have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT) and achieved complete remission (CR/CRh/CRi) with full donor chimerism (≥95% by STR or equivalent method).
Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
Evidence of relapse or disease progression at screening or baseline.
Persistent significant myelosuppression (ANC <1.0×10⁹/L or platelets <25×10⁹/L within 7 days without transfusion support) unrelated to reversible causes.
Active grade 3-4 acute GVHD, or acute GVHD requiring systemic corticosteroids ≥0.5 mg/kg/day prednisone equivalent to control; or active moderate-severe chronic GVHD not well controlled by standard therapy.
Active autoimmune disease requiring systemic immunosuppression.
Parallel
Chidamide
DrugOral chidamide 10 mg twice weekly (BIW) starting at Day +30 to +100 post-transplant. Treatment cycles are 4 weeks each, for a total of 26 cycles (approximately 24 months). Dose may be escalated to 20 mg BIW in case of MRD positivity.
Control Group
Other interventionStandard follow-up without maintenance therapy. Regular assessments are performed per the same schedule as the treatment group.
Relapse-Free Survival (RFS)
Time from randomization to the first occurrence of either: (1) disease relapse/progression confirmed by morphology, imaging, or MRD criteria, or (2) death from any cause. Donor lymphocyte infusion (DLI) triggered by MRD elevation is counted as a relapse event. Assessed by Kaplan-Meier method.
Cumulative Incidence of Relapse (CIR)
Time from randomization to first relapse/progression, treating non-relapse mortality (NRM) as a competing risk. Analyzed using the Fine-Gray subdistribution hazard model.
Overall Survival (OS)
Time from randomization to death from any cause. Assessed by Kaplan-Meier method.
Non-Relapse Mortality (NRM)
Time from randomization to death without prior relapse/progression, treating relapse as a competing risk. Analyzed using the Fine-Gray model.
Cumulative Incidence of Graft-versus-Host Disease (GVHD)
Cumulative incidence of acute GVHD (graded per MAGIC criteria) and chronic GVHD (graded per NIH 2014/2020 criteria), with death as a competing risk.
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