Peripheral T-cell LymphomaPhase 1/2NCT05949944
Linperlisib in Combination With CHOP in Previously Untreated Peripheral T-Cell Lymphoma
A Phase 1/2 study testing Linperlisib in combination with CHOP in people with Peripheral T-cell Lymphoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
This phase Ib/II, single arm, open label, multicenter study is conducted to evaluate the efficacy and safety of linperlisib in combination with CHOP for newly diagnosed PTCL patients, and explore the reasonable dosage of linperlisib when combined with CHOP regimen. 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?
- Linperlisib in combination with CHOP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2023to Dec 2028
- Phase
- Phase 1/2
- 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
- Histologically confirmed PTCL, including peripheral T-cell lymphoma non-specific type (PTCL NOS), angioimmunoblastic T-cell lymphoma (AITL), enteropathy related T-cell lymphoma and liver spleen T-cell lymphoma;
- Has not received anti-tumor treatment in the past;
- There must be at least one evaluable lesion/measurable lesion according to the 2014 Lugano Lymphoma Evaluation Criteria. An evaluable lesion is defined as a lymph node or extra-nodal local lesion that shows increased uptake of 18FDG on PET-CT (higher than the liver), with lesion characteristics consistent with lymphoma manifestations. A measurable lesion is defined as a nodule with a longest diameter of >15mm or an extra-nodal lesion with a longest diameter of >10mm, accompanied by increased uptake of 18FDG. Exclusion of cases without measurable lesions and diffuse uptake of 18FDG in the liver is required;
- Age ≥18 years old, regardless of gender;
- Whole body physical condition score (ECOG) 0-2;
- Expected survival time>3 months;
Show all 9Show fewer
- Adequate bone marrow and organ functions;
- Not accompanied by hemophagocytic syndrome; If the patient is accompanied by clinically diagnosed hemophagocytic syndrome, after targeted anti hemophagocytic syndrome drug treatment, the researcher evaluates the patient's general physical condition to determine whether they can be enrolled.
- Volunteer to participate in clinical research and sign an informed consent form, willing to follow and capable of completing all trial procedures.
Who cannot join
- Received PI3K inhibitor treatment before enrollment;
- A history of other primary invasive malignant tumors that have not been relieved or have not been relieved for more than 3 years;
- Involvement of the central nervous system (meninges or brain parenchyma);
- Individuals who are known to have allergies to any medication in the study
- Participated in clinical trials of other drugs within 4 weeks prior to the start of the study;
- Pregnant or lactating women;
Show all 22Show fewer
- Individuals with active infections, excluding fever related to tumor B symptoms;
- Concomitant diseases and medical history:
- There are many factors affecting oral medicine (such as inability to swallow, chronic diarrhea and Bowel obstruction);
- Individuals with a history of abuse of psychotropic substances who are unable to quit or have mental disorders;
- Subjects with any severe and/or uncontrollable diseases, including:
- Poor blood pressure control (systolic blood pressure ≥ 150mm Hg or diastolic blood pressure ≥ 100 mmHg);
- Suffering from ≥ Level 2 myocardial ischemia or infarction, arrhythmia (including QTc ≥ 450ms (male), QTc ≥ 470ms (female)), and ≥ Level 2 congestive heart failure (New York Heart Association (NYHA) classification);
- Active interstitial pneumonia or other chronic lung diseases, leading to severe impairment of lung function, defined as FEV1 and DLCOc<60% of normal predicted values; A history of interstitial pneumonia caused by COVID-19.
- Liver abnormalities:
- Decompensated cirrhosis (Child Pugh liver function rating of B or C) II Known clinically significant history of liver disease. Including viral hepatitis, known carriers of hepatitis B virus (HBV) must exclude active HBV infection, i.e. HBV DNA positivity (>2500 copies/mL or>500IU/mL, and greater than the upper limit of normal values); Known hepatitis C virus infection (HCV) and HCV RNA positivity (>1 × 103 copies/mL). Note: hepatitis B HBsAg positive subjects who meet the inclusion conditions, whether their HBV DNA is measurable or not, need to continue antiviral treatment (nucleoside analogues are recommended) and regularly monitor HBV DNA; For subjects with positive HBcAb but negative HBsAg in hepatitis B, HBV DNA should be monitored regularly and preventive antiviral treatment should be recommended; Hepatitis C patients need to regularly monitor HCV RNA.
- Renal failure requiring hemodialysis or Peritoneal dialysis;
- Subjects with uncontrolled Pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
- Poor control of diabetes (Fasting blood sugar (FBG)>10mmol/L);
- Urinary routine examination indicates that urine protein is ≥++, and it is confirmed that 24-hour urine protein quantification is greater than 1.0 g;
- . Have a history of immune deficiency, including positive Diagnosis of HIV/AIDS, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation;
- . According to the judgment of the researcher, there are serious accompanying diseases that pose a serious threat to the patient's safety or affect the patient's ability to complete the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University
Guangzhou, Guangdong, 510060
About this study
Official title: Linperlisib in Combination With CHOP in Previously Untreated Peripheral T-Cell Lymphoma：a Single-Arm, Open Lable， Multicenter Clinical Trial（LINCH Study）
This phase Ib/II, single arm, open label, multicenter study is conducted to evaluate the efficacy and safety of linperlisib in combination with CHOP for newly diagnosed PTCL patients, and explore the reasonable dosage of linperlisib when combined with CHOP regimen.
- Conditions
- Peripheral T-cell Lymphoma
- Being tested
- Linperlisib in combination with CHOP
- 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.
Linperlisib in combination with CHOPDrug
Patients will receive six cycles of induction therapy of linperlisib in combination with CHOP regimen. All patients with CR and PR after induction therapy receive linperlisib maintenance therapy every 28 days until disease progression or other reasons lead to discontinuation, and the duration of linperlisib maintenance does not exceed 24 months.
| Study group | Role | What they receive |
|---|---|---|
| Linperlisib in combination with CHOP | Experimental | Patients will receive six cycles of induction therapy of linperlisib in combination with CHOP regimen. All patients with CR and PR after induction therapy receive linperlisib maintenance therapy every 28 days until disease progression or other reasons lead to discontinuation, and the duration of linperlisib maintenance does not exceed 24 months. Receives: Drug: Linperlisib in combination with CHOP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT, Phase Ib)
To identify the DLT
Measured: The first cycle of linperlisib in combination with R-CHOP regimen (21 days)
Complete remission rate (CR rate) based on the 2014 Lugano evaluation criteria (Phase II)
To investigate the antitumor efficacy
Measured: Up to 18 weeks
Secondary outcomes (6)
Overall response rate (ORR)
To investigate the antitumor efficacy
Measured: Up to 18 weeks
Duration of complete remission
To investigate the antitumor efficacy
Measured: From date of complete remission to the study treatment until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Duration of remission (DOR)
To investigate the antitumor efficacy
Measured: From date of remission to the study treatment until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Progression free survival (PFS)
To investigate the antitumor efficacy
Measured: From date of the first injection until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Overall survival (OS)
To investigate the antitumor efficacy
Measured: From date of the first injection until the date of death from ant cause, assessed up to 24 months
Incidence and severity of adverse events (AE) and Serious adverse event (SAE), as well as abnormal laboratory inspection indicators; Quality of Life (QOL).
To identify the incidence of AE, SAE and QOL.
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start15 Aug 2023
- Primary completionSep 2026 (estimated)
- Study completionDec 2028 (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 Sun Yat-sen 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qingqing Cai, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05949944
- Sponsor's protocol ID
- B2023-183
- Status last verified
- Sep 2026
- First submitted
- 10 Jul 2023
- Last updated
- 16 Sep 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 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linperlisib in Combination With CHOP in Previously Untreated Peripheral T-Cell Lymphoma：a Single-Arm, Open Lable， Multicenter Clinical Trial（LINCH Study）
- ClinicalTrials.gov ID
- NCT05949944
- Acronym / sponsor ID
- B2023-183
- Conditions
- Peripheral T-cell Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 18 Jul 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 phase Ib/II, single arm, open label, multicenter study is conducted to evaluate the efficacy and safety of linperlisib in combination with CHOP for newly diagnosed PTCL patients, and explore the reasonable dosage of linperlisib when combined with CHOP regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Linperlisib in combination with CHOP | Experimental | Drug: Linperlisib in combination with CHOPPatients will receive six cycles of induction therapy of linperlisib in combination with CHOP regimen. All patients with CR and PR after induction therapy receive linperlisib maintenance therapy every 28 days until disease progression or other reasons lead to discontinuation, and the duration of linperlisib maintenance does not exceed 24 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed PTCL, including peripheral T-cell lymphoma non-specific type (PTCL NOS), angioimmunoblastic T-cell lymphoma (AITL), enteropathy related T-cell lymphoma and liver spleen T-cell lymphoma;
- Has not received anti-tumor treatment in the past;
- There must be at least one evaluable lesion/measurable lesion according to the 2014 Lugano Lymphoma Evaluation Criteria. An evaluable lesion is defined as a lymph node or extra-nodal local lesion that shows increased uptake of 18FDG on PET-CT (higher than the liver), with lesion characteristics consistent with lymphoma manifestations. A measurable lesion is defined as a nodule with a longest diameter of >15mm or an extra-nodal lesion with a longest diameter of >10mm, accompanied by increased uptake of 18FDG. Exclusion of cases without measurable lesions and diffuse uptake of 18FDG in the liver is required;
- Age ≥18 years old, regardless of gender;
- Whole body physical condition score (ECOG) 0-2;
Key exclusion criteria (22 listed)
- Received PI3K inhibitor treatment before enrollment;
- A history of other primary invasive malignant tumors that have not been relieved or have not been relieved for more than 3 years;
- Involvement of the central nervous system (meninges or brain parenchyma);
- Individuals who are known to have allergies to any medication in the study
- Participated in clinical trials of other drugs within 4 weeks prior to the start of the study;
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 |
|---|---|---|
| Linperlisib in combination with CHOPPatients will receive six cycles of induction therapy of linperlisib in combination with CHOP regimen. All patients with CR and PR after induction therapy receive linperlisib maintenance therapy every 28 days until disease progression or other reasons lead to discontinuation, and the duration of linperlisib maintenance does not exceed 24 months. | Drug | Linperlisib in combination with CHOP |
Primary outcome
Dose-limiting toxicity (DLT, Phase Ib)
Time frame: The first cycle of linperlisib in combination with R-CHOP regimen (21 days)
To identify the DLT
Complete remission rate (CR rate) based on the 2014 Lugano evaluation criteria (Phase II)
Time frame: Up to 18 weeks
To investigate the antitumor efficacy
6 secondary outcomes
Overall response rate (ORR)
Time frame: Up to 18 weeks
Duration of complete remission
Time frame: From date of complete remission to the study treatment until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Duration of remission (DOR)
Time frame: From date of remission to the study treatment until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Progression free survival (PFS)
Time frame: From date of the first injection until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Overall survival (OS)
Time frame: From date of the first injection until the date of death from ant cause, assessed up to 24 months
Incidence and severity of adverse events (AE) and Serious adverse event (SAE), as well as abnormal laboratory inspection indicators; Quality of Life (QOL).
Time frame: Through study completion, an average of 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 16 Sep 2026.
Related trials for Peripheral T-cell Lymphoma
RecruitingPhase 2
A Phase II, Single-center, Single-arm Study Evaluating the Safety and Efficacy of Golidocitinib in the Management of Newly Diagnosed Peripheral T Cell Lymphoma Patients (GOLDEN Study) and Correlative Study
Peripheral T Cell Lymphoma
Not yet recruitingPhase 2
Zilovertamab Vedotin and Lenalidomide (ZiVLen) Therapy for Relapsed/Refractory Peripheral T-Cell Lymphoma
Peripheral T-Cell Lymphoma Refractory
RecruitingPhase 2
Testing the Addition of Duvelisib or CC-486 to the Usual Treatment for Peripheral T-Cell Lymphoma
Angioimmunoblastic T-cell Lymphoma, Enteropathy-Associated T-Cell Lymphoma
Active, not recruitingPhase 2
Allogeneic Hematopoietic Cell Transplantation for Peripheral T Cell Lymphoma
Peripheral T-cell Lymphomas, Lymphoproliferative Disorders
RecruitingPhase 1
Belinostat in Combination With Azacitidine or Pralatrexate for the Treatment of Relapse or Refractory T-cell Lymphoma
Recurrent Anaplastic Large Cell Lymphoma, Recurrent Enteropathy-Associated T-Cell Lymphoma
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Linperlisib in combination with CHOP in people with Peripheral T-cell Lymphoma, run by Sun Yat-sen 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 9 inclusion and 22 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: under way, not looking for participants, as of the sponsor's last update on 16 Sep 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT, Phase Ib) (time frame: The first cycle of linperlisib in combination with R-CHOP regimen (21 days)). 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?
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 16 Sep 2026.