An Open-label, Single-arm, Multicenter Phase II Clinical Study of Azacitidine, Chidamide Combined With PD-1 Monoclonal Antibody in the Treatment of Refractory/Relapsed Peripheral T-cell Lymphoma.

May 19, 2026 updated by: Second Affiliated Hospital of Soochow University
An Open-Label, Single-Arm, Multicenter Phase II Clinical Study to Evaluate the Efficacy of Azacitidine, Chidamide, and PD-1 Monoclonal Antibody in the Treatment of Refractory/Relapsed Peripheral T-Cell Lymphoma.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Suzhou, China, 215000
        • Recruiting
        • The Second Affiliated Hospital of Soochow University Suzhou
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥18 years and ≤75 years, male or female.
  2. Histologically confirmed peripheral T-cell lymphoma (PTCL) by the investigating center, including: peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS); anaplastic large cell lymphoma (ALK-negative or ALK-positive); angioimmunoblastic T-cell lymphoma; enteropathy-associated T-cell lymphoma; NK/T-cell lymphoma; and other PTCL subtypes deemed eligible by the investigator.
  3. Relapsed or refractory disease after at least one prior line of systemic therapy. Relapse is defined as disease recurrence after complete response (CR) or progression after partial response (PR) or stable disease (SD). Refractory disease is defined as progressive disease (PD) after 2 cycles of therapy, or SD after 4 cycles of therapy, or failure to achieve response after adequate last-line therapy (e.g., at least 2-3 cycles of systemic chemotherapy without remission), or progression during treatment.
  4. Patients considered ineligible for autologous hematopoietic stem cell transplantation by the investigator, or those who refuse such treatment.
  5. At least one measurable or evaluable lesion according to the Lugano 2014 classification. Measurable lesion: nodal lesion with longest diameter >1.5 cm and shortest diameter >1.0 cm on CT/PET-CT or MRI; or extranodal lesion with longest diameter >1.0 cm. Evaluable lesion: nodal or extranodal focal uptake on 18F-FDG/PET higher than liver with PET and/or CT features consistent with lymphoma.
  6. ECOG performance status 0-2.
  7. Life expectancy ≥3 months.

  8. Adequate organ and bone marrow function defined as:

    1. Hematology: WBC ≥2.0×10⁹/L (≥1.0×10⁹/L if with bone marrow involvement), ANC ≥1.0×10⁹/L (≥0.5×10⁹/L if with bone marrow involvement), PLT ≥50×10⁹/L (≥30×10⁹/L if with bone marrow involvement), HGB ≥7.0 g/dL; no granulocyte growth factor support, platelet or RBC transfusion within 7 days prior to testing.
    2. Liver function: TBIL ≤1.5×ULN (≤3.0×ULN with liver involvement); ALT and AST ≤2.5×ULN (≤5.0×ULN with liver involvement).
    3. Renal function: Serum Cr ≤1.5×ULN.
    4. Coagulation: INR ≤1.5×ULN; PT and APTT ≤1.5×ULN (unless on anticoagulant therapy with PT/APTT within therapeutic range at screening).
    5. Thyroid function: TSH, FT4, and FT3 within ±10% of normal range (Note: TSH abnormalities due to non-autoimmune causes are acceptable).
    6. Cardiac function: Left ventricular ejection fraction ≥50%, no organic arrhythmia, no significant abnormalities in cardiac enzymes.

Exclusion Criteria:

  1. History of other malignancies within the past 5 years, except for those treated with curative intent (e.g., basal cell carcinoma of the skin, carcinoma in situ).
  2. Patients with significant dysfunction of major organs.
  3. Known involvement of central nervous system (CNS) lymphoma.
  4. History of active bleeding or newly diagnosed thrombotic disease, or those with bleeding tendency receiving anticoagulant therapy.
  5. Known history of Human Immunodeficiency Virus (HIV) infection and/or Acquired Immunodeficiency Syndrome (AIDS).
  6. Patients with active chronic hepatitis B or active hepatitis C.
  7. Systemic corticosteroid therapy or other immunosuppressive therapy required for any condition within 14 days prior to initiation of study treatment.
  8. Active autoimmune disease requiring systemic treatment within the past two years. Patients with autoimmune diseases not requiring systemic treatment in the past two years may be enrolled.
  9. Major surgery within 28 days prior to enrollment, or less than 6 weeks after major organ surgery.
  10. Administration of live attenuated vaccines within 4 weeks prior to enrollment or planned during the study period (influenza vaccines excluded).
  11. Pregnant or lactating women, and subjects of childbearing potential unwilling to use effective contraception.
  12. Psychiatric disorders or individuals unable to provide informed consent.
  13. Active infection, except for tumor-related B-symptom fever.

  14. Poorly controlled cardiac symptoms or diseases, including:

    i. NYHA Class III or higher heart failure ii. Unstable angina iii. Myocardial infarction within the past year iv. Clinically significant arrhythmias

  15. Any other condition deemed by the investigator to make the subject unsuitable for study participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Azacitidine + Chidamide + PD-1 Monoclonal Antibody Combination Therapy Group
Drug: Azacitidine (AZA)

Azacitidine 100 mg is administered subcutaneously once daily from day 1 to day 7.

The PD-1 monoclonal antibody 200 mg is administered by intravenous infusion on day 1.

Chidamide 20 mg is administered orally twice weekly.

Other Names:
  • Chidamide
  • PD-1 Monoclonal Antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: From first dose of study drug until disease progression, initiation of new anti-cancer therapy, or study completion (up to 24 months).
To evaluate the objective response rate (ORR) of azacitidine, chidamide, and PD-1 monoclonal antibody combination therapy in refractory/relapsed peripheral T-cell lymphoma.
From first dose of study drug until disease progression, initiation of new anti-cancer therapy, or study completion (up to 24 months).
Complete Response Rate (CRR)
Time Frame: From first dose of study drug until disease progression, initiation of new anti-cancer therapy, or study completion (up to 24 months).
To evaluate the complete response rate (CR rate) of azacitidine, chidamide, and PD-1 monoclonal antibody combination therapy in refractory/relapsed peripheral T-cell lymphoma.
From first dose of study drug until disease progression, initiation of new anti-cancer therapy, or study completion (up to 24 months).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival（PFS）
Time Frame: Assessed every 12 weeks during the treatment and follow-up period until disease progression or study completion (up to 2 years).
To evaluate the progression-free survival (PFS) rate of azacitidine, chidamide, and PD-1 monoclonal antibody combination therapy in refractory/relapsed peripheral T-cell lymphoma.
Assessed every 12 weeks during the treatment and follow-up period until disease progression or study completion (up to 2 years).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Soochow University

Investigators

  • Study Chair: Bingzong Li, Professor, Second Affiliated Hospital of Soochow University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 31, 2030

Study Registration Dates

First Submitted

May 13, 2026

First Submitted That Met QC Criteria

May 19, 2026

First Posted (Actual)

May 20, 2026

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JD-LK2024096-I01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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