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Study of Linperlisib for Patients with Relapsed or Refractory Peripheral T/NK Cell or Cutaneous T Cell Lymphoma

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effectiveness and safety of a medication called Linperlisib (also known by its code name YY-20394) in treating certain types of lymphoma. Lymphoma is a type of cancer that affects the lymphatic system, which is part of the body's immune system. The specific types of lymphoma being studied in this trial are Peripheral T-cell Lymphoma and Cutaneous T-cell Lymphoma. These are conditions where the cancerous cells are either in the lymph nodes or the skin. The trial is designed for patients whose lymphoma has returned after treatment or has not responded to previous treatments.

The purpose of this study is to evaluate how well Linperlisib works in treating these lymphomas. Participants in the study will take Linperlisib in the form of a tablet. The study will monitor the participants over a period of time to see how their lymphoma responds to the treatment. This includes checking if the cancer shrinks or disappears and observing any side effects that may occur. The study will also look at how long the response lasts and how the treatment affects the participants' overall health and survival.

Participants will be closely monitored by a team of healthcare professionals throughout the study. This includes regular check-ups and tests to assess the progress of the treatment. The study aims to provide valuable information on the potential benefits and risks of using Linperlisib for treating these specific types of lymphoma. The results of this study could help improve treatment options for patients with these challenging conditions in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Beginning of treatment

    Upon joining the study, you will begin treatment with linperlisib. This medication is taken orally in the form of a tablet.

    The dosage and frequency of the medication will be determined by the study team and will be explained to you before you start the treatment.

  2. Step 2

    Regular monitoring

    Throughout the study, your health will be closely monitored. This includes regular visits to the clinic for check-ups and tests to assess your response to the treatment.

    These visits will help ensure that the treatment is working as expected and to manage any side effects you may experience.

  3. Step 3

    Response evaluation

    Your response to the treatment will be evaluated using specific criteria. This involves imaging tests and other assessments to measure the size and activity of the lymphoma.

    The goal is to determine the overall response rate, which includes any reduction in the size of the lymphoma or complete disappearance of the disease.

  4. Step 4

    Continuation or adjustment of treatment

    Based on the results of the evaluations, the study team may decide to continue the current treatment plan or make adjustments as necessary.

    Any changes to your treatment will be discussed with you, and you will be informed about the reasons for these changes.

  5. Step 5

    End of treatment

    The study will continue until the estimated end date or until it is determined that the treatment is no longer beneficial for you.

    At the end of the study, you will have a final evaluation to assess your overall health and the outcomes of the treatment.

Who can join the trial?

17 criteria

  • Adult patient aged 18 years or older at the time of signing the informed consent.
  • Has a measurable disease of CTCL (a type of lymphoma) defined by specific criteria, such as certain blood tests or a score greater than 0 on a specific assessment tool.
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, which means the patient is fully active or has some symptoms but does not require bed rest.
  • Has adequate organ function, which includes specific blood counts, liver and kidney function, and heart function as defined by the study.
  • CTCL patients can participate if they are on stable doses of certain steroids for at least 4 weeks before starting the study treatment.
  • Male patients must agree to use highly effective contraception during the treatment period and for at least 3 months after the last dose, and must not donate sperm during this time.
  • Female patients must not be pregnant or breastfeeding and must agree to use highly effective contraception or be abstinent during the treatment period and for at least 3 months after the last dose. A pregnancy test is required before starting the study treatment.
  • Patient must be capable of giving signed informed consent.
  • Must be willing and able to follow the study and lifestyle restrictions as judged by the investigator.
  • Has a diagnosis of specific types of PTCL (another type of lymphoma) confirmed by a pathologist.
  • Has received and failed at least one line of systemic therapy for PTCL.
  • Has a diagnosis of specific types of CTCL confirmed by a pathologist and at a certain stage.
  • Has received and failed at least one line of systemic therapy for certain stages of CTCL, and at least two lines for other stages.
  • Not a candidate for certain types of transplantation.
  • For patients with CD30+ PTCL, must have progressed on or be ineligible or intolerant to certain treatments.
  • Agree to provide tumor tissue samples or undergo a biopsy before treatment.
  • Has radiographically measurable disease of PTCL as per specific criteria with at least one measurable lesion.

Who cannot join the trial?

10 criteria

  • Patients who have not recovered from previous treatments or therapies.
  • Patients with other active cancers that are not the focus of this study.
  • Patients with severe heart problems.
  • Patients with uncontrolled infections.
  • Patients who are pregnant or breastfeeding.
  • Patients with known allergies to the study medication.
  • Patients who have participated in another clinical trial within the last 4 weeks.
  • Patients with a history of certain autoimmune diseases, which are conditions where the immune system attacks the body.
  • Patients with severe liver or kidney disease.
  • Patients with a history of drug or alcohol abuse.
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Investigated drugs

Linperlisib (YY-20394) is a medication being studied for its potential to help patients with certain types of lymphoma, specifically those who have not responded to previous treatments or whose cancer has returned. This medication works by targeting specific pathways in cancer cells, which may help to stop their growth and spread. The goal of using Linperlisib in this trial is to see if it can improve the condition of patients with these types of lymphoma and to assess its safety and effectiveness. Patients in this study receive Linperlisib as the only treatment to determine its direct impact on their cancer.

What is already known about the treatment

Linperlisib – Linperlisib is administered orally and is currently being studied in clinical trials for its effectiveness and safety in treating certain types of lymphoma, specifically relapsed or refractory peripheral T-cell or natural killer (NK) cell lymphoma, as well as cutaneous T-cell lymphoma. This medication is still under investigation, and its use is primarily within the context of clinical research. Linperlisib works by targeting specific pathways in cancer cells, which helps to stop their growth and spread. It belongs to a class of drugs known as PI3K inhibitors, which interfere with the signaling pathways that cancer cells use to survive and multiply.

Investigated diseases

  • Peripheral T-cell Lymphoma

    Peripheral T-cell lymphoma is a type of non-Hodgkin lymphoma that originates from mature T-cells. It typically presents with symptoms such as swollen lymph nodes, fever, and weight loss. The disease progresses as the abnormal T-cells multiply uncontrollably, affecting lymph nodes and potentially other organs. Over time, it can lead to systemic symptoms and may involve the skin, liver, or bone marrow. The progression can vary, with some cases advancing more rapidly than others.

  • Cutaneous T-cell Lymphoma

    Cutaneous T-cell lymphoma is a rare type of non-Hodgkin lymphoma that primarily affects the skin. It begins with patches or plaques on the skin, which may be itchy or scaly. As the disease progresses, it can lead to thicker skin lesions and potentially spread to lymph nodes and internal organs. The abnormal T-cells in the skin can cause inflammation and damage to the skin tissue. Over time, the disease may evolve into more aggressive forms, affecting the patient's overall health.

Trial detailsLast updated 4 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-501431-16-00Protocol codeYY-20394-012Estimated enrolment107 patientsSponsorShanghai Yingli Pharmaceutical Co. Ltd.

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).