Can adding linperlisib to standard chemotherapy improve outcomes in rare T-Cell lymphoma?

NCT ID NCT05949944

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

Researchers are testing whether adding the experimental drug linperlisib to standard CHOP chemotherapy helps people with newly diagnosed peripheral T-cell lymphoma. The trial enrolls about 44 participants who have not received prior treatment. Everyone receives six cycles of the combination, and those who respond continue linperlisib maintenance for up to two years. The study measures safety, complete remission rate, and how long responses last.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
linperlisib, an experimental drug that blocks a specific enzyme in cancer cells, combined with standard CHOP chemotherapy
What this could lead to
If it works, this combination could offer a new first-line option for people with peripheral T-cell lymphoma, a rare and hard-to-treat cancer.
What could go wrong
This is an early-phase trial with only 44 participants, so it may not show a clear benefit or the results may not apply to everyone. Adding linperlisib to CHOP could also cause extra side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

44 people

The number who actually took part.

Started

Aug 2023

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 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; 2. Has not received anti-tumor treatment in the past; 3. 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; 4. Age ≥18 years old, regardless of gender; 5. Whole body physical condition score (ECOG) 0-2; 6. Expected survival time\>3 months; 7. Adequate bone marrow and organ functions; 8. 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. 9. Volunteer to participate in clinical research and sign an informed consent form, willing to follow and capable of completing all trial procedures. Exclusion Criteria: 1. Received PI3K inhibitor treatment before enrollment; 2. A history of other primary invasive malignant tumors that have not been relieved or have not been relieved for more than 3 years; 3. Involvement of the central nervous system (meninges or brain parenchyma); 4. Individuals who are known to have allergies to any medication in the study 5. Participated in clinical trials of other drugs within 4 weeks prior to the start of the study; 6. Pregnant or lactating women; 7. Individuals with active infections, excluding fever related to tumor B symptoms; 8. Concomitant diseases and medical history: 1. There are many factors affecting oral medicine (such as inability to swallow, chronic diarrhea and Bowel obstruction); 2. Individuals with a history of abuse of psychotropic substances who are unable to quit or have mental disorders; 3. Subjects with any severe and/or uncontrollable diseases, including: 1. Poor blood pressure control (systolic blood pressure ≥ 150mm Hg or diastolic blood pressure ≥ 100 mmHg); 2. 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); 3. 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. 4. Liver abnormalities: I. 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. 5. Renal failure requiring hemodialysis or Peritoneal dialysis; 6. Subjects with uncontrolled Pleural effusion, pericardial effusion, or ascites requiring repeated drainage; 7. Poor control of diabetes (Fasting blood sugar (FBG)\>10mmol/L); 8. Urinary routine examination indicates that urine protein is ≥++, and it is confirmed that 24-hour urine protein quantification is greater than 1.0 g; 9. . 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; 10. . 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University

    Guangzhou, Guangdong, 510060, China

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Other studies related to the condition(s) this trial covers.