Cidabenamine plus azacitidine to prevent post-transplant progression in high-risk peripheral T‑cell lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, single-arm, prospective Phase II trial will enroll approximately 40 high‑risk peripheral T‑cell lymphoma patients who have undergone allogeneic peripheral blood hematopoietic stem cell transplantation. Enrolled participants will receive maintenance therapy with cidabenamine combined with azacitidine and undergo routine safety and disease monitoring. Baseline and follow-up evaluations include PET‑CT, bone marrow studies (aspiration, pathology, flow cytometry, and gene rearrangement), donor T‑cell chimerism, and clinical exams. The primary focus is on preventing post‑transplant progression while documenting adverse events and hematologic recovery.

Why it matters

Who can join: the full rules

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

Exclusion Criteria:

1. Known hypersensitivity to hypomethylating agents or Cidabenamine.
2. Presence of grade II or higher active acute Graft-versus-Host Disease (GVHD).
3. Presence of moderate or more severe chronic GVHD.
4. 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.
5. 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.
6. Known HIV infection.
7. Active Hepatitis B (HBV) or active Hepatitis C (HCV) requiring antiviral therapy.
8. History of an autoimmune disease.
9. Pregnant or lactating women.
10. Concurrent participation in another interventional clinical trial and receiving other investigational drugs.

Where it's running

• Shanghai General hospital,Shanghai Jiao Tong University School of Medicine
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: xianmin song, MD
• Email: shongxm@139.com
• Phone: +862163240090

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.