Newly Diagnosed Peripheral T-cell LymphomaPhase 2NCT05976997
Prospective, Single Arm, Single Center Study of Duvelisib Combined With Chidamide in the Treatment of Newly Diagnosed Peripheral T-cell Lymphoma (PTCL)
A Phase 2 study testing Duvelisib, Chidamide in people with Newly Diagnosed Peripheral T-cell Lymphoma, run by Liling Zhang at 1 site in China.
Trial summary
This is a prospective, single arm, single center study to evaluate the efficacy and safety of Duvelisib combined with Chidamide in the treatment of newly diagnosed peripheral T-cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Newly Diagnosed Peripheral T-cell Lymphoma
- What is being tested?
- Duvelisib, Chidamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 8 May 2023to 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -
- 1.Age: 18-70 Years (Contains boundary values 18 and 70);
- 2.The newly diagnosed PTCL confirmed by histopathology is one of the following subtypes;
- Angioimmunoblastic T-cell lymphoma (AITL); b) Follicular T helper cell lymphoma (T-FHCL); Including but not limited to the above two subtypes;
- 3.ECOG ≤ 3;
- 4.At least one measurable or evaluable tumor lesion according to the Lugano-2014 standard;
- 5.Expected survival ≥ 3 months;
- 6.Subjects fully understand and voluntarily participate in this study and sign informed consent;
Who cannot join
- -
- 1.Subjects who have previously received systemic treatment for lymphoma or currently undergoing anticancer treatment;
- 2.Subjects with central nervous system (CNS) lymphoma or lymphoma involving CNS;
- 3.Significant active heart disease within the past 6 months, including: New York Heart Association (NYHA) Class III/IV congestive heart failure unstable angina pectoris or angina requiring surgical or medication intervention, and/or myocardial infarction;
- 4.Uncontrolled systemic fungal, bacterial, or viral infections (defined as persistent signs/symptoms related to infection that have not improved despite the use of appropriate antibiotics, antiviral therapy, and/or other treatments);
- 5.Human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection and history of severe skin reaction;
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- 6.Subjects with any other active malignant tumor at the time of screening, except for adequately treated cervical Carcinoma in situ or breast cancer Carcinoma in situ, skin Basal-cell carcinoma or local skin squamous cell carcinoma;
- 7.Pregnant women, lactating women, patients who refused to take effective contraceptive measures during the study;
- 8.Any serious uncontrolled systemic disease;
- 9.increasing the risk of the subject or interfering with the test results determined by the investigator;
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
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Liling Zhang, M.D, 0086 27 83262660, lily1228@sina.com
Liling Zhang, M.D
About this study
This is a prospective, single arm, single center study to evaluate the efficacy and safety of Duvelisib combined with Chidamide in the treatment of newly diagnosed peripheral T-cell lymphoma.
Read the detailed description
This is a prospective, single arm, single center study, including two phases. It plans to recruit36 patients with clinically diagnosed primary PTCL who will be treated with Duvelisib and Chidamide. In the first phase Duvelisib is Oral administration at a dose of 25mg twice a day, and every 4 weeks (28 days) was a cycle. Next administration will be depend on whether the efficacy reaches CR in the second phase.
- Being tested
- Duvelisib, Chidamide
- Keywords
- Duvelisib, Chidamide, Peripheral T-cell Lymphoma
- 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.
Duvelisib, ChidamideDrug
Duvelisib, 25mg, BID, PO; Chidamide, 20mg, BIW, PO;
| Study group | Role | What they receive |
|---|---|---|
| Duvelisib-Chidamide | Experimental | Patients with newly diagnosed PTCL were treated with a combination of Duvelisib and Chidamide. The dose of Duvelisib was 25mg twice a day. Every 4 weeks (28 days) is a cycle with a total of 2 cycles. Receives: Drug: Duvelisib, Chidamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Hematologic and non-hematologic toxicities (NCI CTCAE v5.0)
To identify the incidence of AE and SAE in clinical trial
Measured: from the initiation of the first dose to 28 days after the last dose
Secondary outcomes (5)
Objective response rate (ORR)
To evaluate the efficacy of anti-lymphoma
Measured: up to 26 weeks
Complete remission rate (CR)
To evaluate the efficacy of anti-lymphoma
Measured: up to 26 weeks
Duration of Response（DOR）
To evaluate the efficacy of anti-lymphoma
Measured: The time from the first assessment as CR or PR to the first assessment as PD or death (due to any cause)，assessed up to 12 months
Progression free survival (PFS)
To evaluate the efficacy of anti-lymphoma
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 20 months
Overall survival (OS)
To evaluate the efficacy of anti-lymphoma
Measured: From date of randomization until the date of death from any cause, assessed up to 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start8 May 2023
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newly Diagnosed Peripheral T-cell LymphomaStudies 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liling Zhang
- Sponsor type
- University, hospital or other
- Collaborators
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor-investigator, Liling Zhang, Huazhong University of Science and Technology
- Investigators
- Liling Zhang, M.D, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05976997
- Sponsor's protocol ID
- CSPC-KBT-PTCL-C01
- Status last verified
- May 2026
- First submitted
- 16 Jul 2023
- Last updated
- 18 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single Arm, Single Center Study of Duvelisib Combined With Chidamide in the Treatment of Newly Diagnosed Peripheral T-cell Lymphoma (PTCL)
- ClinicalTrials.gov ID
- NCT05976997
- Acronym / sponsor ID
- CSPC-KBT-PTCL-C01
- Keywords
- Duvelisib, Chidamide, Peripheral T-cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Liling ZhangUniversity, hospital or other
- Collaborators
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Study start
- 8 May 2023 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 4 Aug 2023 (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 prospective, single arm, single center study to evaluate the efficacy and safety of Duvelisib combined with Chidamide in the treatment of newly diagnosed peripheral T-cell lymphoma.
Detailed description
This is a prospective, single arm, single center study, including two phases. It plans to recruit36 patients with clinically diagnosed primary PTCL who will be treated with Duvelisib and Chidamide. In the first phase Duvelisib is Oral administration at a dose of 25mg twice a day, and every 4 weeks (28 days) was a cycle. Next administration will be depend on whether the efficacy reaches CR in the second phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Duvelisib-Chidamide | Experimental | Drug: Duvelisib, ChidamidePatients with newly diagnosed PTCL were treated with a combination of Duvelisib and Chidamide. The dose of Duvelisib was 25mg twice a day. Every 4 weeks (28 days) is a cycle with a total of 2 cycles. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- -
- 1.Age: 18-70 Years (Contains boundary values 18 and 70);
- 2.The newly diagnosed PTCL confirmed by histopathology is one of the following subtypes;
- 3.ECOG ≤ 3;
- 4.At least one measurable or evaluable tumor lesion according to the Lugano-2014 standard;
Key exclusion criteria (10 listed)
- -
- 1.Subjects who have previously received systemic treatment for lymphoma or currently undergoing anticancer treatment;
- 2.Subjects with central nervous system (CNS) lymphoma or lymphoma involving CNS;
- 3.Significant active heart disease within the past 6 months, including: New York Heart Association (NYHA) Class III/IV congestive heart failure unstable angina pectoris or angina requiring surgical or medication intervention, and/or myocardial infarction;
- 4.Uncontrolled systemic fungal, bacterial, or viral infections (defined as persistent signs/symptoms related to infection that have not improved despite the use of appropriate antibiotics, antiviral therapy, and/or other treatments);
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 |
|---|---|---|
| Duvelisib, ChidamideDuvelisib, 25mg, BID, PO; Chidamide, 20mg, BIW, PO; | Drug | Duvelisib-Chidamide |
Primary outcome
Safety: Hematologic and non-hematologic toxicities (NCI CTCAE v5.0)
Time frame: from the initiation of the first dose to 28 days after the last dose
To identify the incidence of AE and SAE in clinical trial
5 secondary outcomes
Objective response rate (ORR)
Time frame: up to 26 weeks
Complete remission rate (CR)
Time frame: up to 26 weeks
Duration of Response（DOR）
Time frame: The time from the first assessment as CR or PR to the first assessment as PD or death (due to any cause)，assessed up to 12 months
Progression free survival (PFS)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 20 months
Overall survival (OS)
Time frame: From date of randomization until the date of death from any cause, assessed up to 20 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 18 May 2026.
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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.
Liling Zhang, M.D principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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 Duvelisib, Chidamide in people with Newly Diagnosed Peripheral T-cell Lymphoma, run by Liling Zhang 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 10 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 18 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?
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 Liling Zhang, M.D (0086 27 83262660, lily1228@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Hematologic and non-hematologic toxicities (NCI CTCAE v5.0) (time frame: from the initiation of the first dose to 28 days after the last dose). 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 18 May 2026.