A Clinical Trial of Cidabenamine Plus Azacitidine to Prevent Post-Transplant Progression in High-Risk Peripheral T-Cell Lymphoma
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Aged 18 to 70 years, male or female. 2. 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). 3. Underwent allogeneic peripheral blood hematopoietic stem cell transplantation for PTCL, with no restriction on donor type. 4. Presence of complete donor chimerism in the bone marrow (T-cell chimerism \>95%). 5. ECOG performance status of 0 or 1. 6. Hematological function meeting the following requirements: ① Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹/L; ② Platelet count (PLT) ≥ 50 × 10⁹/L. 7. Patient