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

NCT07389616 | Recruiting Phase 2

• 1 other identifier: SHSYXY-202503-PTCL
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral T Cell Lymphoma

Keywords

Peripheral T Cell Lymphoma; Cidabenamine; high-risk; Azacitidine

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 1 years for the 1y-OS and up to 2 years for the 2y-OS

Secondary Outcomes (3)

• progression-free survival (PFS)

  up to 1 years for the 1y-PFS and up to 2 years for the 2y-PFS

• non-relapse mortality (NRM)

  up to 1 year

• cumulative relapse rates (CIR)

  up to 1 years for the 1y-CIR and up to 2 years for the 2y-CIR

Study Arms (1)

Cidabenamine combined with Azacitidine

EXPERIMENTAL

Drug: Cidabenamine, Azacitidine

Interventions

Cidabenamine, Azacitidine DRUG

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.

Cidabenamine combined with Azacitidine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai General hospital,Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200080, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

Azacitidine

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Central Study Contacts

xianmin song, MD

CONTACT

+862163240090; shongxm@139.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 5, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): August 1, 2029
• Last Updated: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)