Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Single-arm, Phase II Study to Evaluate the Efficacy and Safety of Linperlisib (YY-20394) Monotherapy in Patients with Relapsed or Refractory Peripheral T/NK Cell or Cutaneous T Cell Lymphoma

This is a study looking at a new medicine called Linperlisib. It's for adults with certain types of T-cell lymphoma, specifically Peripheral T/NK Cell Lymphoma (PTCL) or Cutaneous T Cell Lymphoma (CTCL), where their disease has either returned after initial treatment or hasn't responded to previous therapies. The main goal is to find out if Linperlisib can shrink the lymphoma tumors (how effective it is) and if it causes any unwanted side effects (how safe it is). Researchers will carefully monitor patients to see how their lymphoma responds to the drug and track any changes in their health. This information will help doctors understand if Linperlisib could be a good treatment option in the future.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Shanghai Yingli Pharmaceutical Co. Ltd., Shanghai Yingli Pharmaceutical Co. Ltd.

Enrolment target

Start

25 Nov 2022

Relapsed or Refractory Peripheral T/NK Cell or Cutaneous T Cell Lymphoma

What is this study about?

This research study is about a new drug, Linperlisib, which is being tested for certain types of T-cell lymphoma. Lymphoma is a type of cancer that starts in white blood cells called lymphocytes. The specific types of lymphoma in this study are Peripheral T/NK Cell Lymphoma (PTCL) and Cutaneous T Cell Lymphoma (CTCL). People included in this study have lymphoma that has either come back after they've had treatment before (this is called 'relapsed') or it hasn't responded to their previous treatments (this is called 'refractory').

The main purpose of this study is to see how well Linperlisib works. Doctors want to know if it can cause the lymphoma to shrink or disappear. They will also be looking very carefully at any side effects the drug might cause, to understand how safe it is. By gathering this information, researchers hope to learn if Linperlisib could be a useful new treatment option for people living with these specific lymphomas.

This is a 'Phase II' study, which means the drug has already passed early safety tests, and now researchers are focusing on how effective it is in a larger group of people with the condition. The results of this study will help determine if Linperlisib should be studied further in even larger trials.

Key takeaways

This study tests a new drug, Linperlisib, for certain T-cell lymphomas.
It's for lymphoma that has come back or not responded to previous treatments.
The main goals are to check if the drug works (efficacy) and its safety.
Participants must be aged 18 or over.
Regular clinic visits and health monitoring will be required.

Who may be eligible?

To join this study, you must be 18 years old or older. The study is open to both men and women.

You would be considered if you have been diagnosed with Peripheral T/NK Cell Lymphoma (PTCL) or Cutaneous T Cell Lymphoma (CTCL). Importantly, your lymphoma must have either returned after previous treatment or not have responded well to treatments you've had in the past.

There might be other health requirements or previous treatment details that your doctor will need to check to make sure participating in this study is right and safe for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have Peripheral T/NK Cell Lymphoma (PTCL) or Cutaneous T Cell Lymphoma (CTCL)?
Has your lymphoma either returned after previous treatment or not responded to earlier treatments?
Are you able to attend regular clinic appointments for monitoring?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given the experimental drug, Linperlisib. The study involves regular visits to the clinic so doctors can monitor your health closely. These visits will likely include physical examinations, blood tests, and scans to check how your lymphoma is responding to the treatment.

Researchers will also be closely watching for any side effects you might experience. It's important to report any new symptoms to your study doctor or nurse. The total time you spend in the study will depend on how you respond to the treatment and the decisions made by your medical team.

Potential risks and benefits

Participating in this study might offer a potential benefit: you could receive a new treatment for your lymphoma that isn't widely available yet, which might help if other treatments haven't worked or if your lymphoma has come back. However, like all medications, Linperlisib could have side effects, which range from mild to more serious; the study will carefully track these. You would be fully informed of all known potential risks before deciding to join. Remember, taking part in any study is completely voluntary, and you can choose to leave the study at any time, for any reason, without affecting your standard medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy

Common questions

What is Linperlisib?

Linperlisib is a new drug being tested to treat specific types of T-cell lymphoma. We are trying to find out how well it works and if it's safe.

What kind of lymphoma is this study for?

This study is for adults with Peripheral T/NK Cell Lymphoma (PTCL) or Cutaneous T Cell Lymphoma (CTCL) that has returned or not responded to previous treatments.

Why is this considered a 'Phase II' study?

Phase II means the drug has passed initial safety tests, and now researchers are mainly focused on how effective it is at treating the condition in a larger group of people.

Will taking part in the study cost me anything?

Generally, costs directly related to the study treatment and procedures are covered by the research sponsor. You should discuss any potential personal costs with the study team.

What happens after the study ends?

After the study ends, your doctor will discuss your best treatment options moving forward, which might include approved therapies or other clinical trials, depending on your individual situation and the study results.