Peripheral T-Cell Lymphoma RefractoryEarly Phase 1NCT07598578
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.
A Early Phase 1 study testing Azacitidine (AZA) in people with Peripheral T-Cell Lymphoma Refractory, run by Second Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Peripheral T-Cell Lymphoma Refractory
- What is being tested?
- Azacitidine (AZA)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 31 Jan 2030
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years and ≤75 years, male or female.
- 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.
- 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.
- Patients considered ineligible for autologous hematopoietic stem cell transplantation by the investigator, or those who refuse such treatment.
- 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.
- ECOG performance status 0-2.
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- Life expectancy ≥3 months.
- Adequate organ and bone marrow function defined as:
- 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.
- Liver function: TBIL ≤1.5×ULN (≤3.0×ULN with liver involvement); ALT and AST ≤2.5×ULN (≤5.0×ULN with liver involvement).
- Renal function: Serum Cr ≤1.5×ULN.
- Coagulation: INR ≤1.5×ULN; PT and APTT ≤1.5×ULN (unless on anticoagulant therapy with PT/APTT within therapeutic range at screening).
- Thyroid function: TSH, FT4, and FT3 within ±10% of normal range (Note: TSH abnormalities due to non-autoimmune causes are acceptable).
- Cardiac function: Left ventricular ejection fraction ≥50%, no organic arrhythmia, no significant abnormalities in cardiac enzymes.
Who cannot join
- 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).
- Patients with significant dysfunction of major organs.
- Known involvement of central nervous system (CNS) lymphoma.
- History of active bleeding or newly diagnosed thrombotic disease, or those with bleeding tendency receiving anticoagulant therapy.
- Known history of Human Immunodeficiency Virus (HIV) infection and/or Acquired Immunodeficiency Syndrome (AIDS).
- Patients with active chronic hepatitis B or active hepatitis C.
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- Systemic corticosteroid therapy or other immunosuppressive therapy required for any condition within 14 days prior to initiation of study treatment.
- 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.
- Major surgery within 28 days prior to enrollment, or less than 6 weeks after major organ surgery.
- Administration of live attenuated vaccines within 4 weeks prior to enrollment or planned during the study period (influenza vaccines excluded).
- Pregnant or lactating women, and subjects of childbearing potential unwilling to use effective contraception.
- Psychiatric disorders or individuals unable to provide informed consent.
- Active infection, except for tumor-related B-symptom fever.
- Poorly controlled cardiac symptoms or diseases, including:
- NYHA Class III or higher heart failure ii. Unstable angina iii. Myocardial infarction within the past year iv. Clinically significant arrhythmias
- Any other condition deemed by the investigator to make the subject unsuitable for study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Soochow University Suzhou
Suzhou, 215000
Kang Lu, Master, 0086-15162517756, 15162517756@163.com
About this study
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.
- Conditions
- Peripheral T-Cell Lymphoma Refractory
- Being tested
- Azacitidine (AZA)
- Keywords
- therapy, Azacitidine, Chidamide, PD-1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azacitidine (AZA)Drug
Also called Chidamide, PD-1 Monoclonal Antibody
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.
| Study group | Role | What they receive |
|---|---|---|
| Azacitidine + Chidamide + PD-1 Monoclonal Antibody Combination Therapy Group | Experimental | Not described Receives: Drug: Azacitidine (AZA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
To evaluate the objective response rate (ORR) of azacitidine, chidamide, and PD-1 monoclonal antibody combination therapy in refractory/relapsed peripheral T-cell lymphoma.
Measured: 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)
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.
Measured: From first dose of study drug until disease progression, initiation of new anti-cancer therapy, or study completion (up to 24 months).
Secondary outcomes (1)
Progression-free survival（PFS）
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.
Measured: Assessed every 12 weeks during the treatment and follow-up period until disease progression or study completion (up to 2 years).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jan 2030 (estimated)
- Study completion31 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peripheral T-Cell Lymphoma RefractoryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bingzong Li, Professor, Study chair, Second Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07598578
- Sponsor's protocol ID
- JD-LK2024096-I01
- Status last verified
- May 2026
- First submitted
- 13 May 2026
- Last updated
- 20 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Angelos MG, Ballard HJ, Barta SK. Advances and Personalized Approaches in the Frontline Treatment of T-Cell Lymphomas. J Pers Med. 2022 Feb 11;12(2):267. doi: 10.3390/jpm12020267.
PubMed 35207754Foley NC, Mehta-Shah N. Management of Peripheral T-cell Lymphomas and the Role of Transplant. Curr Oncol Rep. 2022 Nov;24(11):1489-1499. doi: 10.1007/s11912-022-01310-3. Epub 2022 Aug 10.
PubMed 35947286
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07598578
- Acronym / sponsor ID
- JD-LK2024096-I01
- Conditions
- Peripheral T-Cell Lymphoma Refractory
- Keywords
- therapy, Azacitidine, Chidamide, PD-1
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 31 Jan 2030 (estimated)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Azacitidine + Chidamide + PD-1 Monoclonal Antibody Combination Therapy Group | Experimental | Drug: Azacitidine (AZA) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age ≥18 years and ≤75 years, male or female.
- 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.
- 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.
- Patients considered ineligible for autologous hematopoietic stem cell transplantation by the investigator, or those who refuse such treatment.
- 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.
Key exclusion criteria (16 listed)
- 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).
- Patients with significant dysfunction of major organs.
- Known involvement of central nervous system (CNS) lymphoma.
- History of active bleeding or newly diagnosed thrombotic disease, or those with bleeding tendency receiving anticoagulant therapy.
- Known history of Human Immunodeficiency Virus (HIV) infection and/or Acquired Immunodeficiency Syndrome (AIDS).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Azacitidine (AZA)Also: Chidamide, PD-1 Monoclonal AntibodyAzacitidine 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. | Drug | Azacitidine + Chidamide + PD-1 Monoclonal Antibody Combination Therapy Group |
Primary outcome
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.
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.
1 secondary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Background: PubMed 35207754Angelos MG, Ballard HJ, Barta SK. Advances and Personalized Approaches in the Frontline Treatment of T-Cell Lymphomas. J Pers Med. 2022 Feb 11;12(2):267. doi: 10.3390/jpm12020267.
- Background: PubMed 35947286Foley NC, Mehta-Shah N. Management of Peripheral T-cell Lymphomas and the Role of Transplant. Curr Oncol Rep. 2022 Nov;24(11):1489-1499. doi: 10.1007/s11912-022-01310-3. Epub 2022 Aug 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bingzong Li, Professor study chair
Second Affiliated Hospital of Soochow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Azacitidine (AZA) in people with Peripheral T-Cell Lymphoma Refractory, run by Second Affiliated Hospital of Soochow University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kang Lu, Master (0086-15162517756, 15162517756@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07598578, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.