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

A Clinical Study of Cidabenamine Combined With Azacitidine for Preventing Progression in High-Risk Peripheral T-Cell Lymphoma After Allogeneic Peripheral Blood Hematopoietic Stem Cell Transplantation

This trial will test whether adding cidabenamine to azacitidine after allogeneic stem cell transplant can help prevent progression in adults with high‑risk peripheral T‑cell lymphoma.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07389616 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–70 with a 2022 WHO diagnosis of peripheral T‑cell lymphoma who meet the trial's high‑risk criteria, have received allogeneic peripheral blood HSCT, show >95% T‑cell donor chimerism, have ECOG 0–1, and adequate blood counts are the intended candidates.

Not a fit: Patients with incomplete donor chimerism, ECOG >1, significant cytopenias, or excluded subtypes such as hepatosplenic T‑cell lymphoma are unlikely to meet eligibility or derive benefit from this protocol.

Why it matters

Potential benefit: If successful, the regimen could lower relapse risk after transplant and extend remission duration for patients with high‑risk PTCL.

How similar studies have performed: While azacitidine has demonstrated post‑transplant activity in other hematologic malignancies, combining it with cidabenamine for high‑risk PTCL is novel and has not been well established.

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. 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 this trial is running

Shanghai, Shanghai Municipality

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

Study contacts

• Study coordinator: xianmin song, MD

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