Peripheral T-cell LymphomaPhase 2Sincerely20NCT04512534
Sintilimab Combined With Chidamide in Treating Peripheral T Cell Lymphoma
A Phase 2 study testing PD-1 antibody+ HDAC inhibitor in people with Peripheral T-cell Lymphoma, run by Fudan University at 1 site in China.
Trial summary
This is a single-center, single-arm, phase 2 study to evaluate the efficacy and safety of Anti-PD-1 antibody(Sintilimab) plus HDAC inhibitor(Chidamide) in patients with relapsed/refractory peripheral T-cell lymphoma (r/r PTCL). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Peripheral T-cell Lymphoma
- What is being tested?
- PD-1 antibody+ HDAC inhibitor
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteChina
- Study dates
- 13 Nov 2020to 31 Dec 2026
- Phase
- Phase 2
- 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 range from 18 to 75 years;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- Pathologically confirmed relapsed/refractory Peripheral T-cell lymphoma (Including PTCL-NOS, AITL, anaplastic large cell lymphoma（ALTL）, excluding Nature Killer（NK）/T cell lymphoma);
- At least one two-dimensional measurable lesion with a length diameter of at least 1.5cm and vertical diameter of at least 1.0cm (measured by CT or MRI);
- Adequate medullary hematopoiesis function ( WBC≥3.5×109/L, ANC≥1.5×109/L, PLT≥80×109/L, HB≥90g/L. If the peripheral blood indicators demonstrate abnormal due to bone marrow or spleen invasion by lymphoma, Enrollment decision can be determined by the investigator as appropriate;
- Adequate hepatic function (total serum bilirubin, ALT and AST≤1.5 times of upper limit of normal);
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- Adequate renal function (serum creatinine≤1.5 times the upper limit of normal, creatinine clearence≥50ml/min);
- Echocardiography or radionuclide cardia functional test, LVEF≥50%;
- Patients of child-bearing period agree to use appropriate contraception. The serum pregnancy test of women in childbearing period was negative within 2 weeks before enrollment.
- Willingness to provide pathological tissue specimens (20 pieces of wax or paraffin tissue sections);
- Expectation survival time over 3 months;
- Willingness to provide written informed consent.
Who cannot join
- Patients allergic of any drug in this regimen;
- Previous treatment with anti-PD-1 antibody combined with HDAC inhibitor (Patients only received single agent of treatment regime or sequentially received anti-PD-1 and HDAC inhibitor are allowed to enroll);
- Patients with clinically significant heart disease, including severe cardiac insufficiency: New York Heart Disease Association (NYHA) grade IV cardiac insufficiency, unstable angina. And myocardial infarction, congestive heart failure, and QTC interphase > 500ms which occurred before 6 month of screening;
- Patients who have received grade II or above surgery within 3 weeks before enrollment;
- History of other malignancy within the past 5 years (except for 1. basal cell carcinoma of the skin and 2. carcinoma in situ of the cervix and 3. patients who had received treatment for the purpose of cure and had not developed a malignant tumor with a known active disease in the previous 5 years);
- Patients who had received other antitumor therapy (including corticosteroid therapy, immunotherapy) or participated in other clinical studies within 4 weeks before the start of the enrollment (if patients received small-molecule targeted drug therapy, they could be included in the study if the drug was discontinued for more than 5 half-lives), or had not recovered from the previous toxicity;
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- Patients with significant coagulation abnormality;
- Patients with autoimmune diseases requiring treatment or with a history of syndrome requiring systemic use of steroid immunosuppressive agents, such as hypophysitis, pneumonia, colitis, hepatitis, nephritis, hyperthyroidism, hypothyroidism, etc;
- Other serious, uncontrolled concomitant diseases that may affect protocol compliance or interfere with results interpretation, including uncontrolled diabetes, or pulmonary disease (a history of interstitial pneumonia, obstructive pulmonary disease, and symptomatic bronchospasm);
- Evidence of central nervous system disease;
- Patients who received the live vaccine within 4 weeks of the start of the enrollment;
- Patients with hepatitis B (HBV HBsAg positive and HBV-DNA≥105), hepatitis C (HCV) infection (HCV antibody positive and HCV-RNA detectable); And subjects with other acquired or congenital immune deficiency diseases, including but not limited to hiv-infected;
- Pregnant or lactating women;
- Patients who have had previous organ transplants (except autologous hematopoietic stem cell transplants);
- Severe or uncontrolled infections;
- Patients with history of severe neurological or psychiatric illness, including dementia or epilepsy;
- Patients with drug abuse, medical, psychological or social conditions that may interfere with the study results or the assessment of the study results;
- Patients are unsuitable for the enrollment according to investigator's judgement.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Junning Cao, doctor contact
China1 site, 1 recruiting
- Recruiting
Dongmei Ji
Shanghai, Shanghai Municipality, 021
dongmei ji, doctor
dongmei ji, doctor, 13564183928, jidongmei2000@126.com
About this study
Official title: A Phase II Study of Anti-Programmed Death-1(PD-1) Antibody Sintilimab Plus Histone Deacetylase(HDAC) Inhibitor Chidamide in Patients With Relapsed/ Refractory Peripheral T-cell Lymphoma
This is a single-center, single-arm, phase 2 study to evaluate the efficacy and safety of Anti-PD-1 antibody(Sintilimab) plus HDAC inhibitor(Chidamide) in patients with relapsed/refractory peripheral T-cell lymphoma (r/r PTCL).
Read the detailed description
Peripheral T-cell lymphoma accounts for 12-15% of non-Hodgkin's lymphomas in western countries, however, this number is up to 35% or more in some Asian countries, including China. According to the 2016 World Health Organization annual classification, there are 29 subtypes of peripheral T cell lymphoma, among which the most common types are peripheral T cell lymphoma non-specific type (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL) and anaplastic large cell lymphoma (ALCL). For r/r PTCL, the prognosis was poor with objective response rate range from 8-50% and median progression free survival（PFS）range from 3.2-5 months for chemotherapy. Thus, the treatment of this patient population remained clinically unmet need.
This clinical trial will be conducted under Simon's optimal two-stage design. The first stage needs 15 participants, if ≥5 participants acquire remission, the study will move on to the second stage and enroll another 36 patients to achieve a total number of 51 participants enrolled. Drop rate is assumed to be 10%, to insure 47 participants involving the efficacy evaluation statistically.
Participants will receive anti-PD-1 antibody plus HDAC inhibitor every three weeks for a cycle, until disease progression or severe/ intolerant toxicity, the maximum treatment period is 2 years.
- Conditions
- Peripheral T-cell Lymphoma
- Being tested
- PD-1 antibody+ HDAC inhibitor
- Keywords
- relapsed/refractory peripheral T-cell lymphoma, PD-1 antibody, HDAC inhibitor, objective response rate, safety profile
- Medical subject headings
- Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1 antibody+ HDAC inhibitorDrug
Also called Sintilimab, Chidamide
Patients receive anti-PD-1 antibody Sintilimab+ HDAC inhibitor Chidamide three weeks for a cycle, detailed as follows:
- Anti-PD-1 antibody (Sintilimab): Fixed dose of 200 mg every 3 weeks, intravenous drip (without pretreatment), infusion time: 30 minutes (no less than 20 mins, no more than 60 mins), the maximum treatment period is 2 years (up to 35 doses), complete remission（CR）patients confirmed by imaging assessment can be considered off anti-PD-1 treatment after 12 treatment cycles.
- Chidamide: Chidamide is administered orally at a dose of 30mg (initial dose). It is recommended to be administered within 0.5h after a meal with a fixed time. Chidamide will be given until disease progression or intolerant toxicity. The maximum treatment is 2 years. If chidamide therapy requires to be continued over 2 years due to clinical benefit, the prescription/decision should be made after discussion with the principal investigator.
| Study group | Role | What they receive |
|---|---|---|
| Sinitilimab+Chidamide | Experimental | Anti-PD-1 antibody Sintilimab 200mg intravenously every 3 weeks; HDAC inhibitor Chidamide 30mg orally twice every week Receives: Drug: PD-1 antibody+ HDAC inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
Time from the data of enrollment to of disease progression, or death of any cause, or date of lost follow-up, whichever comes first, otherwise subject data were censored at time last known disease free.
Measured: Up to two years after the start of the study
Secondary outcomes (2)
Overall Survival (OS)
Time from the date of enrollment to data of death from any cause, or date of lost follow-up, whichever comes first, and otherwise censored at time last known alive.
Measured: Up to two years after the start of the study
incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
All the adverse events of the patients related will be assessed and graded by NCI CTCAE v 5.0]
Measured: Since the signing of informed consent forms to 30 days after the last cycle of treatment and 90 days after last dose of anti-PD-1 antibody
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start13 Nov 2020
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral T-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Simon's optimal two-stage design
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Dongmei, Fudan University
- Investigators
- Dongmei Ji, doctor, Principal investigator, Fudan UniversityJunning Cao, Doctor, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04512534
- Sponsor's protocol ID
- Sincerely2020
- Acronym
- Sincerely20
- Status last verified
- Mar 2026
- First submitted
- 10 Aug 2020
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Anti-Programmed Death-1(PD-1) Antibody Sintilimab Plus Histone Deacetylase(HDAC) Inhibitor Chidamide in Patients With Relapsed/ Refractory Peripheral T-cell Lymphoma
- ClinicalTrials.gov ID
- NCT04512534
- Acronym / sponsor ID
- Sincerely20 / Sincerely2020
- Conditions
- Peripheral T-cell Lymphoma
- Keywords
- relapsed/refractory peripheral T-cell lymphoma, PD-1 antibody, HDAC inhibitor, objective response rate, safety profile
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 13 Nov 2020 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Aug 2020 (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.
This is a single-center, single-arm, phase 2 study to evaluate the efficacy and safety of Anti-PD-1 antibody(Sintilimab) plus HDAC inhibitor(Chidamide) in patients with relapsed/refractory peripheral T-cell lymphoma (r/r PTCL).
Detailed description
Peripheral T-cell lymphoma accounts for 12-15% of non-Hodgkin's lymphomas in western countries, however, this number is up to 35% or more in some Asian countries, including China. According to the 2016 World Health Organization annual classification, there are 29 subtypes of peripheral T cell lymphoma, among which the most common types are peripheral T cell lymphoma non-specific type (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL) and anaplastic large cell lymphoma (ALCL). For r/r PTCL, the prognosis was poor with objective response rate range from 8-50% and median progression free survival（PFS）range from 3.2-5 months for chemotherapy. Thus, the treatment of this patient population remained clinically unmet need.
This clinical trial will be conducted under Simon's optimal two-stage design. The first stage needs 15 participants, if ≥5 participants acquire remission, the study will move on to the second stage and enroll another 36 patients to achieve a total number of 51 participants enrolled. Drop rate is assumed to be 10%, to insure 47 participants involving the efficacy evaluation statistically.
Participants will receive anti-PD-1 antibody plus HDAC inhibitor every three weeks for a cycle, until disease progression or severe/ intolerant toxicity, the maximum treatment period is 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Simon's optimal two-stage design
| Arm | Type | Receives |
|---|---|---|
| Sinitilimab+Chidamide | Experimental | Drug: PD-1 antibody+ HDAC inhibitorAnti-PD-1 antibody Sintilimab 200mg intravenously every 3 weeks; HDAC inhibitor Chidamide 30mg orally twice every week |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age range from 18 to 75 years;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- Pathologically confirmed relapsed/refractory Peripheral T-cell lymphoma (Including PTCL-NOS, AITL, anaplastic large cell lymphoma（ALTL）, excluding Nature Killer（NK）/T cell lymphoma);
- At least one two-dimensional measurable lesion with a length diameter of at least 1.5cm and vertical diameter of at least 1.0cm (measured by CT or MRI);
- Adequate medullary hematopoiesis function ( WBC≥3.5×109/L, ANC≥1.5×109/L, PLT≥80×109/L, HB≥90g/L. If the peripheral blood indicators demonstrate abnormal due to bone marrow or spleen invasion by lymphoma, Enrollment decision can be determined by the investigator as appropriate;
Key exclusion criteria (18 listed)
- Patients allergic of any drug in this regimen;
- Previous treatment with anti-PD-1 antibody combined with HDAC inhibitor (Patients only received single agent of treatment regime or sequentially received anti-PD-1 and HDAC inhibitor are allowed to enroll);
- Patients with clinically significant heart disease, including severe cardiac insufficiency: New York Heart Disease Association (NYHA) grade IV cardiac insufficiency, unstable angina. And myocardial infarction, congestive heart failure, and QTC interphase > 500ms which occurred before 6 month of screening;
- Patients who have received grade II or above surgery within 3 weeks before enrollment;
- History of other malignancy within the past 5 years (except for 1. basal cell carcinoma of the skin and 2. carcinoma in situ of the cervix and 3. patients who had received treatment for the purpose of cure and had not developed a malignant tumor with a known active disease in the previous 5 years);
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 |
|---|---|---|
| PD-1 antibody+ HDAC inhibitorAlso: Sintilimab, ChidamidePatients receive anti-PD-1 antibody Sintilimab+ HDAC inhibitor Chidamide three weeks for a cycle, detailed as follows: * Anti-PD-1 antibody (Sintilimab): Fixed dose of 200 mg every 3 weeks, intravenous drip (without pretreatment), infusion time: 30 minutes (no less than 20 mins, no more than 60 mins), the maximum treatment period is 2 years (up to 35 doses), complete remission（CR）patients confirmed by imaging assessment can be considered off anti-PD-1 treatment after 12 treatment cycles. * Chidamide: Chidamide is administered orally at a dose of 30mg (initial dose). It is recommended to be administered within 0.5h after a meal with a fixed time. Chidamide will be given until disease progression or intolerant toxicity. The maximum treatment is 2 years. If chidamide therapy requires to be continued over 2 years due to clinical benefit, the prescription/decision should be made after discussion with the principal investigator. | Drug | Sinitilimab+Chidamide |
Primary outcome
Progression Free Survival (PFS)
Time frame: Up to two years after the start of the study
Time from the data of enrollment to of disease progression, or death of any cause, or date of lost follow-up, whichever comes first, otherwise subject data were censored at time last known disease free.
2 secondary outcomes
Overall Survival (OS)
Time frame: Up to two years after the start of the study
incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Since the signing of informed consent forms to 30 days after the last cycle of treatment and 90 days after last dose of anti-PD-1 antibody
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 2 Apr 2026.
- 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.
Junning Cao, doctor contact
Dongmei Ji, doctor principal investigator
Fudan University
Junning Cao, Doctor principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PD-1 antibody+ HDAC inhibitor in people with Peripheral T-cell Lymphoma, run by Fudan 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 12 inclusion and 18 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 2 Apr 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Dongmei Ji, doctor (13564183928, jidongmei2000@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: Up to two years after the start of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Apr 2026.