A Clinical Trial of Cidabenamine Plus Azacitidine to Prevent Post-Transplant Progression in High-Risk Peripheral T-Cell Lymphoma

Inclusion criteria

• Aged 18 to 70 years, male or female.
• Diagnosis of peripheral T-cell lymphoma (PTCL) according to the 2022 WHO criteria, including pathological subtypes such as PTCL not otherwise specified (PTCL-NOS), anaplastic large cell lymphoma (ALCL), and angioimmunoblastic T-cell lymphoma (AITL), but excluding hepatosplenic T-cell lymphoma; and meeting at least one of the following high-risk criteria:

① Stable Disease (SD) at the time of transplantation;

② Relapse after autologous hematopoietic stem cell transplantation (any disease status);

③ ≥ Partial Response 1 (PR1).

• Underwent allogeneic peripheral blood hematopoietic stem cell transplantation for PTCL, with no restriction on donor type.
• Presence of complete donor chimerism in the bone marrow (T-cell chimerism >95%).
• ECOG performance status of 0 or 1.
• Hematological function meeting the following requirements:

① Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹/L;

② Platelet count (PLT) ≥ 50 × 10⁹/L.

• Patients must have the ability to understand and be willing to participate in the study and must provide signed informed consent.

Exclusion criteria

• Known hypersensitivity to hypomethylating agents or Cidabenamine.
• Presence of grade II or higher active acute Graft-versus-Host Disease (GVHD).
• Presence of moderate or more severe chronic GVHD.
• Any unstable systemic disease, including but not limited to: unstable angina, cerebrovascular accident or transient ischemic attack (within 3 months prior to screening), myocardial infarction (within 3 months prior to screening), congestive heart failure (New York Heart Association [NYHA] Class ≥ III), status post pacemaker implantation, severe arrhythmia requiring pharmacological treatment, hepatic, renal, or metabolic disease, or pulmonary hypertension.
• Active, uncontrolled infection, evidenced by any of the following: infection-related hemodynamic instability, worsening or new-onset infectious symptoms/signs, radiologic evidence of a new infectious focus, or persistent fever without localizing symptoms/signs where infection cannot be ruled out.
• Known HIV infection.
• Active Hepatitis B (HBV) or active Hepatitis C (HCV) requiring antiviral therapy.
• History of an autoimmune disease.
• Pregnant or lactating women.
• Concurrent participation in another interventional clinical trial and receiving other investigational drugs.