RecruitingPHASE3INTERVENTIONAL

A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

This study is looking at a new medicine called pirtobrutinib (also known as LOXO-305) and comparing it to a standard treatment, ibrutinib, for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). These are types of slow-growing blood cancers. The study has two main parts. Part 1 compares the new drug to ibrutinib in people who may or may not have been treated for their cancer before. Part 2 focuses on people who haven't had treatment for their CLL/SLL and have a specific gene change called a '17p deletion'. The main goal is to see how well pirtobrutinib works and if it's safe. Taking part could last up to six years for Part 1 or up to two years for Part 2.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Loxo Oncology, Inc.

Enrolment target

662

Start

22 Jul 2022

Estimated completion

01 Jan 2028

Chronic Lymphocytic Leukemia Leukemia, Lymphocytic Leukemia, B-cell Small Lymphocytic Lymphoma

What is this study about?

This research study is investigating a new medication called pirtobrutinib, also known as LOXO-305. It's being compared with ibrutinib, which is a common treatment for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). These are both types of cancer that affect certain white blood cells. The researchers want to find out if pirtobrutinib is better or safer than ibrutinib for treating these conditions.

The study is divided into two main groups. One group (Part 1) will include people who have CLL/SLL, whether they've had treatment for it before or not. They will receive either pirtobrutinib or ibrutinib. The other group (Part 2) will focus specifically on people who are newly diagnosed with CLL/SLL, meaning they haven't had previous treatment, and who also have a particular genetic change in their cancer cells called a '17p deletion'. This specific deletion can sometimes make CLL/SLL harder to treat, so finding effective options for this group is very important. Everyone in Part 2 will receive pirtobrutinib.

The reason for conducting this study is to hopefully offer patients more effective and safe treatment options for CLL/SLL, especially for those with specific features like the 17p deletion. By carefully comparing these medicines, scientists can learn more about how to best manage these conditions and improve the lives of people affected by them.

Key takeaways

This study compares a new drug (pirtobrutinib) with a standard one (ibrutinib) for CLL/SLL.
It's for adults, including those newly diagnosed and those previously treated.
A special part of the study focuses on people with a gene change called '17p deletion'.
Participation involves regular hospital visits for up to six years.
You will receive either pirtobrutinib or ibrutinib, usually as a pill.
The main goals are to check how well the drugs work and if they are safe.

Who may be eligible?

To join this study, you must be an adult aged 18 or older and have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Your doctor will need to confirm your diagnosis meets specific medical guidelines.

For Part 1 of the study, it's important to know if your cancer cells have a particular gene change called a '17p deletion'. You can be included whether you have this deletion or not. For Part 2, you must have this '17p deletion' in your cancer cells and not have received any previous treatment for your CLL/SLL.

There are also some general health requirements. For example, your organs like your kidneys and blood should be working well enough. You also shouldn't have certain other serious health issues, such as active infections like hepatitis B or C, severe heart problems, or other types of lymphoma or pre-existing conditions that might make the study treatment unsafe for you.

Quick self-check

Are you 18 years old or older?
Do you have a confirmed diagnosis of CLL or SLL?
Is your general health good enough for a clinical trial (e.g., organ function)?
Have you discussed your '17p deletion' status with your doctor?
Do you have any serious heart problems, active infections, or other significant illness?

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

What does participation involve?

If you decide to take part, your participation could last for different lengths of time depending on which part of the study you're in. For Part 1, it could be up to six years, while for Part 2, it could be up to two years.

Throughout the study, you'll have regular visits to the clinic for check-ups. These visits will include various assessments such as blood tests (to check your blood counts, organ function, and other markers), physical examinations, and possibly other tests like scans. You will be given the study medication, either pirtobrutinib or ibrutinib, usually as a pill you take at home. The research team will monitor you closely for any side effects and to see how the treatment is working. After the main treatment period, there will be a follow-up period to continue monitoring your health.

Potential risks and benefits

Taking part in any clinical trial involves both potential benefits and risks. You might benefit from receiving a new treatment that could be more effective than existing options, or your cancer might respond well to the study medication. However, there's also a chance the new treatment might not work for you, or you could experience side effects. These could range from mild to serious. The research team will explain all known side effects and monitor you very closely. You should know that taking part is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (144)

Pacific Cancer Medical Center, Inc
Anaheim, United States· Recruiting
TOI Clinical Research
Cerritos, United States· Recruiting
Stanford School of Medicine-Cancer Clinical Trials Office
Palo Alto, United States· Recruiting
California Cancer Associates for Research and Excellence
San Marcos, United States· Active not recruiting
Florida Cancer Specialists
Fort Myers, United States· Recruiting
Cancer Specialists of North Florida -St Augustine
Saint Augustine, United States· Recruiting
Florida Cancer Specialists East
West Palm Beach, United States· Recruiting
Hematology Oncology Clinic
Baton Rouge, United States· Active not recruiting
Tulane Cancer Center Office of Clinical Research
New Orleans, United States· Active not recruiting
American Oncology Partners of Maryland, PA
Bethesda, United States· Recruiting
St. Vincent Frontier Cancer Center
Billings, United States· Recruiting
Cancer Care Associates of York
York, United States· Active not recruiting

+132 more sites — see the official record for the full list.

Common questions

What is CLL/SLL?

CLL (Chronic Lymphocytic Leukemia) and SLL (Small Lymphocytic Lymphoma) are slow-growing types of cancer that affect certain white blood cells in your body.

What is a '17p deletion'?

A '17p deletion' is a specific change in the genes of cancer cells which can sometimes make CLL/SLL more challenging to treat. This study is specially looking at this group of patients.

What are pirtobrutinib and ibrutinib?

Pirtobrutinib is a new experimental medicine, and ibrutinib is a standard medicine already used to treat CLL/SLL. Both are types of targeted therapies.

Will I know which medicine I'm getting?

In Part 1, you might be given either pirtobrutinib or ibrutinib, and often participants and their doctors don't know who is getting which (this is called 'blinded'). In Part 2, everyone will receive pirtobrutinib.

Is travel to the hospital always needed?

Yes, you will need to attend regular appointments at the hospital or clinic for check-ups, blood tests, and to get your study medication. The team will provide details on the frequency of these visits.

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.