RecruitingPHASE4INTERVENTIONAL

A Master Protocol to Evaluate the Long-Term Safety of (LY3527727) Pirtobrutinib

This study, known as a 'master protocol,' is designed to keep track of the long-term safety and effects of a medication called pirtobrutinib. It's for adults with chronic lymphocytic leukemia or non-Hodgkin lymphoma who have previously taken part in other clinical studies involving pirtobrutinib. If you were in one of these earlier studies, you might have the chance to join this one to continue your treatment or remain under observation. This helps doctors gather important information over a longer period to understand the medicine better. It's about ensuring ongoing care and collecting more data on how pirtobrutinib works in the long run.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

Eli Lilly and Company

Enrolment target

787

Start

20 May 2025

Estimated completion

01 Dec 2032

Chronic Lymphocytic Leukemia Non-Hodgkin Lymphoma

What is this study about?

This study is called a 'master protocol,' and it's set up to check the long-term safety of a medicine named pirtobrutinib. This medicine is used to treat certain types of blood cancers, specifically chronic lymphocytic leukemia and non-Hodgkin lymphoma. Instead of being a brand new study for new participants, it's designed for people who have already finished other research studies on pirtobrutinib.

The main idea is to allow these participants to continue receiving the treatment they were on, or to keep having follow-up check-ups. By doing this, doctors can gather more information about the medicine over a longer period. This helps them understand whether the medicine is safe and effective in the long run, and how people tolerate it over many months or even years. It's a way to keep learning about pirtobrutinib outside of the initial shorter-term studies.

Each person who joins this long-term study will have a specific plan based on their original study. Think of it like connecting several shorter paths into one long journey to see what happens over the whole route. This combined information helps medical researchers build a complete picture of pirtobrutinib's effects for patients.

Key takeaways

This study is for long-term safety monitoring of pirtobrutinib.
It's only for people previously in other pirtobrutinib studies.
You might continue treatment or just have follow-up visits.
The study helps doctors understand the medicine's long-term effects.
Participation is voluntary, and you can withdraw anytime.
It focuses on chronic lymphocytic leukemia and non-Hodgkin lymphoma.

Who may be eligible?

This study is for adults over 18 years old. It's specifically for people who are currently, or have recently been, part of another clinical study sponsored by Lilly (the company developing pirtobrutinib) where they received pirtobrutinib.

To put it simply, you can't join this study if you haven't already taken part in one of those specific pirtobrutinib trials. If you're unsure if your previous study counts, the research team running this trial will be able to check for you.

There might be other reasons why someone can't join, which would be explained in more detail depending on the specific study you were in before. The research team will go over all the requirements with you.

Quick self-check

Are you 18 years old or older?
Have you participated in a previous Lilly-sponsored study for pirtobrutinib?
Are you receiving or have you received pirtobrutinib in that earlier trial?
Do you want to continue your treatment or follow-up for your blood cancer?

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

What does participation involve?

If you join this study, your participation will depend on whether you are continuing treatment or just having follow-up check-ups. You would either keep taking the medicine pirtobrutinib as prescribed, or you would attend regular appointments for health checks. These appointments would likely involve physical exams, blood tests, and possibly other tests to monitor your health and how the medicine is affecting you.

The exact schedule and what happens at each visit will depend on the specific path you're on in the study. The total length of your participation can vary significantly, as this is a long-term safety study. You would be informed of the expected duration of your involvement, which could be many months or even years, allowing doctors to collect long-term data. You can always ask the study team for details about what your particular involvement would look like.

Potential risks and benefits

Taking part in this study could offer the benefit of continuing your treatment with pirtobrutinib, which may help manage your condition. It also helps doctors learn more about the long-term safety and effects of the medication, potentially helping future patients. However, like all medicines, pirtobrutinib can have side effects, and some of these might be serious. Participating also means regular hospital visits and tests, which can be time-consuming. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (38)

Cancer Specialists, LLC
Jacksonville, United States· Not yet recruiting
Sylvester Comprehensive Cancer Center
Miami, United States· Recruiting
Florida Cancer Specialists
Sarasota, United States· Recruiting
The Emory Clinic
Atlanta, United States· Not yet recruiting
Northwestern University
Chicago, United States· Not yet 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· 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· Not yet recruiting

+26 more sites — see the official record for the full list.

Common questions

What is pirtobrutinib?

Pirtobrutinib is a medicine being studied to treat certain blood cancers like chronic lymphocytic leukemia and non-Hodgkin lymphoma.

Who can join this study?

Only adults (18+) who have already been in another Lilly-sponsored study where they received pirtobrutinib can join this study.

Why is this study happening?

This study aims to discover the long-term safety and effects of pirtobrutinib, building on what was learned in earlier studies.

Will I keep getting the medicine?

If you join, you might continue receiving pirtobrutinib treatment, or you might just have regular follow-up check-ups, depending on your situation.

What if I want to stop participating?

You are free to leave the study at any time, for any reason, and it won't affect your regular 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.