A Phase 2/3 interventional study of Cidabenamine, Azacitidine in Peripheral T Cell Lymphoma, sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-02-05.
Sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Phase 2/3, Interventional, and Treatment
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.
604 studies on the registry are indexed under Lymphoma, T-Cell, Peripheral; 133 are open to participants now.
This study's planned enrollment of 40 is close to the median of 38 across 527 interventional studies indexed under Lymphoma, T-Cell, Peripheral.
Browse Lymphoma, T-Cell, Peripheral studies →Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine is the lead sponsor of 173 studies on the registry; 105 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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).
Hematological function meeting the following requirements:
① Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹/L;
② Platelet count (PLT) ≥ 50 × 10⁹/L.
Exclusion Criteria:
Drug: Cidabenamine, Azacitidine
In 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.
Time frame: up to 1 years for the 1y-OS and up to 2 years for the 2y-OS
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.
Time frame: up to 1 years for the 1y-PFS and up to 2 years for the 2y-PFS
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.
Time frame: up to 1 year
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.
Time frame: up to 1 years for the 1y-CIR and up to 2 years for the 2y-CIR
Plan to share: No
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Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine