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 study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Universita Degli Studi Di Brescia	Brescia	Italy
Ayivvhc Uqiuh Shayvwdma Lzpvzo Dq Bqxxrru	Bologna	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	30.09.2022

Trial locations

Investigated drugs:

Linperlisib

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.

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 ID:

2022-501431-16-00

Protocol code:

YY-20394-012

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?