Peripheral T-Cell LymphomaPhase 2NCT07746245
The Efficacy of CAPCT in Patients With PTCL
A Phase 2 study testing Chidamide, Azacitidine (AZA) and Prednisone in people with Peripheral T-Cell Lymphoma, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
This study is a multicenter, single-arm, non-randomized, open-label trial designed to evaluate the efficacy and safety of chidamide and azacitidine in combination with prednisone, cyclophosphamide, and thalidomide (CAPCT regimen) in patients with peripheral T-cell lymphoma (PTCL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral T-Cell Lymphoma
- What is being tested?
- Chidamide, Azacitidine (AZA) and Prednisone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2026to 31 Jul 2029
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients with histopathologically confirmed peripheral T-cell lymphoma (PTCL), with exclusion of NK/T-cell lymphoma.
- 2. Patients who are treatment-naïve or have relapsed/refractory disease.
- 3. Patients who are intolerant to standard chemotherapy regimens for various reasons, including those aged ≥75 years, or those aged <75 years but deemed by the investigator to be unsuitable for or unable to tolerate chemotherapy.
- 4. Patients aged ≥18 years, male or female.
- 5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-3.
- 6. Absolute neutrophil count ≥1.5×10⁹/L, platelet count ≥50×10⁹/L, and hemoglobin ≥70 g/L.
- 7. Estimated life expectancy ≥3 months.
- 8. Voluntary signing of written informed consent.
Who cannot join
- 1. Pregnant or lactating women, or fertile patients of childbearing potential who are unwilling to adopt contraceptive measures.
- 2. Patients with chronic heart failure of New York Heart Association (NYHA) functional class III or IV; or those with a history of any of the following cardiac conditions within 6 months: acute coronary syndrome; acute heart failure (NYHA functional class III or IV); or significant ventricular arrhythmias (sustained ventricular tachycardia, ventricular fibrillation, or sudden cardiac death after resuscitation).
- 3. Hepatic dysfunction (total bilirubin >1.5× the upper limit of normal [ULN]; alanine aminotransferase [ALT] and aspartate aminotransferase [AST] >2.0× ULN, or >5× ULN in patients with hepatic involvement); or renal dysfunction (serum creatinine >1.5× ULN).
- 4. Confirmed central nervous system (CNS) involvement by lymphoma.
- 5. Receipt of prior myelosuppressive symptomatic treatment within 7 days before enrollment.
- 6. Active hemorrhage/bleeding.
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- 7. Patients with acquired immunodeficiency syndrome (AIDS), syphilis, or active hepatitis B (HBV DNA >1×10⁵ copies/mL) or hepatitis C.
- 8. Receipt of grade II or higher surgery within 3 weeks prior to treatment.
- 9. Psychiatric disorders or inability to provide informed consent.
- 10. Patients deemed by the investigator to be unsuitable for participation in this trial.
- 11. Known allergy to any component of the investigational drug.
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
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu
Wei Xu, 13951699449, xuwei10000@hotmail.com
About this study
Official title: Multicenter, Single-Arm, Open-Label Clinical Study to Observe the Efficacy of Chidamide Combined With Azacitidine, Prednisone, Cyclophosphamide, and Thalidomide in Patients With Peripheral T-Cell Lymphoma (PTCL) Who Are Intolerant to Standard Chemotherapy.
This study is a multicenter, single-arm, non-randomized, open-label trial designed to evaluate the efficacy and safety of chidamide and azacitidine in combination with prednisone, cyclophosphamide, and thalidomide (CAPCT regimen) in patients with peripheral T-cell lymphoma (PTCL). A total of 58 patients with PTCL are planned to be enrolled after providing written informed consent and meeting all eligibility criteria. Enrolled patients will receive the CAPCT regimen, with each cycle consisting of 21 days, for a total of 6 cycles. Participants who do not experience disease progression or unacceptable toxicity after 6 cycles of combination therapy will continue to receive the CPCT regimen (chidamide combined with prednisone, cyclophosphamide, and thalidomide) for up to 6 months, followed by chidamide monotherapy as maintenance treatment. The primary efficacy endpoint is objective response rate (ORR).
- Conditions
- Peripheral T-Cell Lymphoma
- Being tested
- Chidamide, Azacitidine (AZA), Prednisone, Cyclophosphamide, Thalidomide (100mg)
- Keywords
- PTCL, HDACi
- 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.
ChidamideDrug
Chidamide tablets,：Oral administration at a dose of 20 mg (4 tablets) per intake, twice weekly, with an interval of no less than 3 days between the two doses .
Azacitidine (AZA)Drug
Subcutaneous injection at a dose of 100 mg/day on Days 1-7
PrednisoneDrug
Oral administration at a dose of 20 mg/day, taken after breakfast.
CyclophosphamideDrug
Oral administration at a dose of 50 mg/day, taken after lunch.
Thalidomide (100mg)Drug
Oral administration at a dose of 100 mg/day, taken before bedtime.
| Study group | Role | What they receive |
|---|---|---|
| CAPCT | Experimental | chidamide and azacitidine in combination with prednisone, cyclophosphamide, and thalidomide (CAPCT regimen) Receives: Drug: Chidamide; Drug: Azacitidine (AZA); Drug: Prednisone; Drug: Cyclophosphamide; Drug: Thalidomide (100mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate（ORR）
The proportion of patients who achieve a CR 、CRu and PR
Measured: Up to 2 years
Secondary outcomes (4)
Duration of Response（DoR）
The time from the first documented objective response (CR or PR) to the first documented disease progression or death from any cause.
Measured: Up to 2 years
Progression-Free Survival（PFS）
The time from the start of treatment to the first documented disease progression or death from any cause, whichever occurs first.
Measured: From treatment to the end of treatment at 12months
Overall Survival（OS）
The time from the start of treatment to death from any cause.
Measured: From treatment to the end of treatment at 24 months
Adverse Event
AEs
Measured: From enrollment to the end of treatment at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2029 (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 The First Affiliated Hospital with Nanjing Medical 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
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WEI XU, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07746245
- Sponsor's protocol ID
- 2026-SR-420
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 5 Aug 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 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Single-Arm, Open-Label Clinical Study to Observe the Efficacy of Chidamide Combined With Azacitidine, Prednisone, Cyclophosphamide, and Thalidomide in Patients With Peripheral T-Cell Lymphoma (PTCL) Who Are Intolerant to Standard Chemotherapy.
- ClinicalTrials.gov ID
- NCT07746245
- Acronym / sponsor ID
- 2026-SR-420
- Conditions
- Peripheral T-Cell Lymphoma
- Keywords
- PTCL, HDACi
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 5 Aug 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.
This study is a multicenter, single-arm, non-randomized, open-label trial designed to evaluate the efficacy and safety of chidamide and azacitidine in combination with prednisone, cyclophosphamide, and thalidomide (CAPCT regimen) in patients with peripheral T-cell lymphoma (PTCL). A total of 58 patients with PTCL are planned to be enrolled after providing written informed consent and meeting all eligibility criteria. Enrolled patients will receive the CAPCT regimen, with each cycle consisting of 21 days, for a total of 6 cycles. Participants who do not experience disease progression or unacceptable toxicity after 6 cycles of combination therapy will continue to receive the CPCT regimen (chidamide combined with prednisone, cyclophosphamide, and thalidomide) for up to 6 months, followed by chidamide monotherapy as maintenance treatment. The primary efficacy endpoint is objective response rate (ORR).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAPCT | Experimental | Drug: Chidamide, Drug: Azacitidine (AZA), Drug: Prednisone, Drug: Cyclophosphamide, Drug: Thalidomide (100mg)chidamide and azacitidine in combination with prednisone, cyclophosphamide, and thalidomide (CAPCT regimen) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1. Patients with histopathologically confirmed peripheral T-cell lymphoma (PTCL), with exclusion of NK/T-cell lymphoma.
- 2. Patients who are treatment-naïve or have relapsed/refractory disease.
- 3. Patients who are intolerant to standard chemotherapy regimens for various reasons, including those aged ≥75 years, or those aged <75 years but deemed by the investigator to be unsuitable for or unable to tolerate chemotherapy.
- 4. Patients aged ≥18 years, male or female.
- 5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-3.
Key exclusion criteria (11 listed)
- 1. Pregnant or lactating women, or fertile patients of childbearing potential who are unwilling to adopt contraceptive measures.
- 2. Patients with chronic heart failure of New York Heart Association (NYHA) functional class III or IV; or those with a history of any of the following cardiac conditions within 6 months: acute coronary syndrome; acute heart failure (NYHA functional class III or IV); or significant ventricular arrhythmias (sustained ventricular tachycardia, ventricular fibrillation, or sudden cardiac death after resuscitation).
- 3. Hepatic dysfunction (total bilirubin >1.5× the upper limit of normal [ULN]; alanine aminotransferase [ALT] and aspartate aminotransferase [AST] >2.0× ULN, or >5× ULN in patients with hepatic involvement); or renal dysfunction (serum creatinine >1.5× ULN).
- 4. Confirmed central nervous system (CNS) involvement by lymphoma.
- 5. Receipt of prior myelosuppressive symptomatic treatment within 7 days before enrollment.
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 |
|---|---|---|
| ChidamideChidamide tablets,：Oral administration at a dose of 20 mg (4 tablets) per intake, twice weekly, with an interval of no less than 3 days between the two doses . | Drug | CAPCT |
| Azacitidine (AZA)Subcutaneous injection at a dose of 100 mg/day on Days 1-7 | Drug | CAPCT |
| PrednisoneOral administration at a dose of 20 mg/day, taken after breakfast. | Drug | CAPCT |
| CyclophosphamideOral administration at a dose of 50 mg/day, taken after lunch. | Drug | CAPCT |
| Thalidomide (100mg)Oral administration at a dose of 100 mg/day, taken before bedtime. | Drug | CAPCT |
Primary outcome
Objective Response Rate（ORR）
Time frame: Up to 2 years
The proportion of patients who achieve a CR 、CRu and PR
4 secondary outcomes
Duration of Response（DoR）
Time frame: Up to 2 years
Progression-Free Survival（PFS）
Time frame: From treatment to the end of treatment at 12months
Overall Survival（OS）
Time frame: From treatment to the end of treatment at 24 months
Adverse Event
Time frame: From enrollment to the end of treatment at 24 months
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 5 Aug 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.
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 Chidamide, Azacitidine (AZA) and Prednisone in people with Peripheral T-Cell Lymphoma, run by The First Affiliated Hospital with Nanjing Medical 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 8 inclusion and 11 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: opening soon, as of the sponsor's last update on 5 Aug 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 Wei Xu (+86 13951699449, xuwei10000@hotmail.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: Up to 2 years). 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 5 Aug 2026.