CClinicalTrials.gg
RecruitingNCT07389616Updated Feb 5, 2026

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

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

Phase
Phase 2/3
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Peripheral T Cell Lymphoma

Keywords

  • Peripheral T Cell Lymphoma
  • Cidabenamine
  • high-risk
  • Azacitidine
03

In context

Lymphoma, T-Cell, Peripheral

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Cidabenamine combined with Azacitidine

    Drug: Cidabenamine, Azacitidine

Interventions

  • DrugCidabenamine, 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.

06

What researchers measure

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.

    Time frame: up to 1 years for the 1y-OS and up to 2 years for the 2y-OS

Secondary outcomes

  1. 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

  2. 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

  3. 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

07

Study locations

1 of 1 sites recruiting
  • Shanghai General hospital,Shanghai Jiao Tong University School of Medicine
    Shanghai, Shanghai Municipality 200080, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07389616
Lead sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Responsible party
Xianmin Song, MD (Professor, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine) — Principal investigator
First posted
Feb 5, 2026
Start date
Feb 1, 2026 (estimated)
Primary completion
Feb 1, 2028 (estimated)
Completion
Aug 1, 2029 (estimated)
Last update
Feb 5, 2026

Study contacts

xianmin song, MD
Contact
shongxm@139.com
+862163240090

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion