This study is a single-center, single-arm, prospective, phase II clinical trial designed to evaluate the efficacy and safety of Cidabenamine combined with Azacitidine as maintenance therapy following allogeneic peripheral blood hematopoietic stem cell transplantation in patients with high-risk peripheral T-cell lymphoma.During the screening/baseline period, informed consent will be obtained, and inclusion/exclusion criteria will be verified. The study plans to enroll 40 patients in each group. Enrolled patients will undergo demographic and medical history data collection, along with assessments including vital signs, physical examination, PET-CT, bone marrow aspiration smear, flow cytometry, lymphoid gene rearrangement, and bone marrow pathology.
Aged 18 to 70 years, male or female.
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.
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.
Single group
Cidabenamine, Azacitidine
DrugIn the study, Cidabenamine combined with Azacitidine are used as maintenance therapy following allogeneic peripheral blood hematopoietic stem cell transplantation in patients with high-risk peripheral T-cell lymphoma.
overall survival (OS)
The probability of survival at years, measured from the date of transplantation to death from any cause. Patients who are still alive at the time of analysis will be censored on the last follow-up date.
progression-free survival (PFS)
Progression-Free Survival (PFS) is defined as the time from transpalntation until the first occurrence of disease progression or death from any cause, whichever occurs earlier.
non-relapse mortality (NRM)
Death occurring after transplantation due to causes other than disease relapse, such as infection, organ toxicity, or transplantation-related complications. Deaths from any cause in the absence of prior relapse are considered events for this endpoint.
cumulative relapse rates (CIR)
The cumulative probability of disease progression (including relapse or progression of the primary disease) within 1 years after transplantation, with non-progression-related death treated as a competing event.
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