RecruitingPHASE4INTERVENTIONAL

A Study of (LY3527727) Pirtobrutinib in Participants With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Non-Hodgkin Lymphoma

This study is for people in the UK who are currently taking part in a specific clinical trial (LOXO-BTK-18001) for chronic lymphocytic leukaemia (CLL), small lymphocytic lymphoma (SLL), or non-Hodgkin lymphoma. The medicine being studied is called pirtobrutinib. If you're already in the original study, you might be able to continue taking your study medicine or continue your check-up visits by joining this new study. The main goal is to understand the long-term safety and how well pirtobrutinib works for these conditions over a longer period. This will help doctors learn more about providing the best care for patients like you.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

Eli Lilly and Company

Enrolment target

279

Start

20 May 2025

Estimated completion

01 Dec 2032

Chronic Lymphocytic Leukemia Non-Hodgkin Lymphoma

What is this study about?

This research is a continuation of an ongoing study for people with certain types of blood cancer: chronic lymphocytic leukaemia (CLL), small lymphocytic lymphoma (SLL), or non-Hodgkin lymphoma. The medicine being investigated is called pirtobrutinib. If you are currently enrolled and actively involved in the original study, called LOXO-BTK-18001, this new study offers a way for you to keep going with your treatment or follow-up.

The main purpose of this follow-up study is to gather more information about pirtobrutinib. Researchers want to learn more about its long-term safety – meaning are there any side effects that appear over a longer period? – and also how effective the medicine continues to be in managing these cancers over time. This kind of information is vital because it helps doctors and scientists understand the full picture of a medicine's effects.

By understanding these long-term effects, medical professionals can make more informed decisions about treating these cancers in the future. This study isn't about starting a new treatment; it's about continuing to observe and learn from people who are already receiving pirtobrutinib or are in a follow-up phase from the original study.

Key takeaways

This study is a continuation for current participants in a pirtobrutinib trial.
It aims to understand the long-term safety and effectiveness of the medicine.
It's for people with chronic lymphocytic leukaemia or non-Hodgkin lymphoma.
You must be 18 years or older and already in the original study to join.
Participation means continuing your current treatment or follow-up plan.
You can leave the study at any time without affecting your care.

Who may be eligible?

To be part of this particular study, you must already be taking part in a specific earlier study called LOXO-BTK-18001. This means you are currently either receiving the study medicine, or you are in a follow-up period where doctors are checking on your health after your treatment period.

Almost anyone aged 18 or older can take part, regardless of whether you are male or female. The study is specifically designed for people who have already started treatment or follow-up under the original study. This helps ensure that the researchers are looking at the long-term effects in a consistent group of patients.

However, if you were part of a very early-stage group (called Phase 1b) in the original LOXO-BTK-18001 study, you would not be able to join this particular continuation study.

Quick self-check

Are you currently taking part in the LOXO-BTK-18001 study?
Are you still receiving the study medicine, or are you in your follow-up period for that study?
Are you 18 years old or older?
Were you NOT part of the very first phase (Phase 1b) of the LOXO-BTK-18001 study?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, it means you will continue what you're already doing in the original study. This could involve continuing to take your assigned study medicine, pirtobrutinib. Or, if you've finished your treatment period, it could mean continuing with your regular check-up visits. These visits are important for doctors to monitor your health, how you're feeling, and how well the medicine is working or has worked for you. You won't start any new treatment, but rather, continue your current study plan. The total duration of your participation will depend on the original study's plan and how long doctors need to keep track of your health, but it is focused on long-term observation.

Potential risks and benefits

The potential benefit of continuing in this study is contributing to valuable long-term knowledge about pirtobrutinib and its effectiveness for your condition, which can help many others in the future. For you personally, it means continued follow-up and access to the study medication if you are still taking it. As with any medicine or study, there may be potential risks, including side effects from pirtobrutinib or inconveniences from study visits, although these are already known from the original study you are in. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (36)

Sylvester Comprehensive Cancer Center
Miami, United States· Recruiting
Florida Cancer Specialists
Sarasota, United States· Recruiting
The Emory Clinic
Atlanta, United States· Recruiting
Northwestern University
Chicago, United States· Recruiting
Dana-Farber Cancer Institute
Boston, United States· Recruiting
Mayo Clinic- Minnesota
Rochester, United States· Recruiting
University Of Nebraska Medical Center
Omaha, United States· Recruiting
Cayuga Cancer Center
Ithaca, United States· Active not recruiting
Northwell Health
Lake Success, United States· Recruiting
Memorial Sloan-Kettering Cancer Center (MSKCC) - New York
New York, United States· Recruiting
Memorial Sloan-Kettering Cancer Center (MSKCC) - New York
New York, United States· Active not recruiting
Duke University Medical Center
Durham, United States· Recruiting

+24 more sites — see the official record for the full list.

Common questions

What is pirtobrutinib?

Pirtobrutinib is a medicine being studied for certain kinds of blood cancer, like chronic lymphocytic leukaemia and non-Hodgkin lymphoma.

Why is this new study happening if I'm already in one?

This new study is a way to continue monitoring your health and the effects of pirtobrutinib over a longer period, gathering important long-term information.

Will I get a different medicine in this new study?

No, if you join this study, you will continue with the same study medicine or follow-up plan you had in the original study. No new treatment will be given.

How long will I be in this study?

The study aims for long-term follow-up, so your participation will continue as long as is necessary to gather useful information, based on the original study's plan.

Can I stop being part of the study at any time?

Yes, you have the right to stop participating in the study at any point, and this will not affect your usual medical care.

How to find out more

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

LillyTrials@Lilly.com 1-317-615-4559 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.