RecruitingPHASE2INTERVENTIONAL

A Study Evaluating the Efficacy and Safety of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

This study is looking at a new medicine called Pirtobrutinib for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). It's for people whose cancer either hasn't responded well to previous treatments, or has come back after treatment. It's also open to people who haven't had treatment for CLL/SLL but have a specific change in their genes called a 17p deletion. The study has two main parts. Part 1 aims to work out the best dose of Pirtobrutinib for people who have already had 1 to 3 types of treatment, including a specific kind of drug called a BTK inhibitor. Part 2 will look at how well Pirtobrutinib works on its own for people who haven't had treatment before but have that 17p gene change. Researchers want to see if the medicine is safe and effective in these groups of people.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Loxo Oncology, Inc.

Enrolment target

249

Start

03 Jan 2025

Estimated completion

01 Dec 2028

Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

What is this study about?

This study focuses on a new drug called Pirtobrutinib for people living with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Both CLL and SLL are types of cancer that affect white blood cells, and while they are similar, they appear in different parts of the body.

The study is divided into two main groups, or 'parts,' to look at different situations. Part 1 is for people who have already had treatments for their CLL/SLL, specifically between one and three types of treatment, including a group of medicines called BTK inhibitors. For these individuals, the study aims to find the most effective and safest dose of Pirtobrutinib. Part 2 is for people newly diagnosed with CLL/SLL who haven't had any treatment yet, but they must have a specific gene change known as a '17p deletion.' In this group, the researchers want to see how well Pirtobrutinib works as their first treatment.

The overall goal of this study is to understand if Pirtobrutinib can be a safe and helpful new treatment option for people with CLL/SLL, whether they've already tried other treatments or are starting treatment for the first time with a specific genetic marker. By taking part, you would be helping doctors learn more about this medicine and potentially improve future treatments for others.

Key takeaways

This study is testing a new drug, Pirtobrutinib, for CLL/SLL.
It's for people who have either had previous treatments or are newly diagnosed with a specific gene change (17p deletion).
Participation involves taking Pirtobrutinib and having regular check-ups.
The study aims to understand if the drug is safe and helps improve CLL/SLL.
You can stop participating in the study at any time.
Potential benefits include a new treatment option; potential risks include side effects.

Who may be eligible?

To join this study, your doctors will need to confirm you have chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) based on standard medical guidelines.

If you're considering Part 1 of the study, you would need to have already received between one and three different treatments for your CLL/SLL, including a type of medicine called a BTK inhibitor. For Part 2, you must not have had any previous treatment for your CLL/SLL, and your cancer cells need to have a specific gene change called a '17p deletion.' Your doctor will check for this (and your doctor will know if you have a 17p deletion for Part 1 as well).

Additionally, you need to be able to swallow tablets or capsules, and generally be well enough to take part in a study, as assessed by a doctor. There are also some conditions that would prevent you from joining, such as having had certain other serious cancers recently, or a history of severe bleeding issues related to previous BTK inhibitor treatment. Also, if your cancer has spread to your brain or spinal cord, you wouldn't be able to participate.

Quick self-check

I have been diagnosed with CLL or SLL.
I can swallow tablets or capsules whole.
I am generally well and active enough for daily activities (doctors use a scale for this).
If I've had treatment before, it was between 1 and 3 different types, including a BTK inhibitor (Part 1).
If I haven't had treatment before, my cancer cells have a '17p deletion' (Part 2).
I haven't had certain other serious cancers in the last 3 years.

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 in this study, the doctors and nurses will regularly check on your health and how the medicine is affecting you. You'll be taking the study medicine, Pirtobrutinib, as directed by the study team. You'll have regular hospital visits for check-ups, blood tests, and other assessments to see how you're responding to the treatment and to monitor for any side effects.

For people in Part 1 of the study, your involvement is expected to last for about 3 years. For those in Part 2, the expected duration is up to 2 years. Throughout this time, your health will be carefully monitored by the study team. They will explain exactly what each visit involves and how often you'll need to attend.

Potential risks and benefits

Taking part in any medical study has potential benefits and potential risks. A possible benefit of joining this study is that Pirtobrutinib might help with your CLL/SLL, especially if other treatments haven't worked well for you, or if it's a new option for your specific type of CLL/SLL. However, as with all medicines, there could be side effects, and the treatment might not work for everyone. These side effects can range from mild to serious, and the study team will monitor you closely for any issues. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (131)

Ironwood Cancer & Research Centers
Chandler, United States· Recruiting
City of Hope National Medical Center
Duarte, United States· Recruiting
City of Hope National Medical Center
Irvine, United States· Recruiting
Palo Alto Medical Foundation Research Institute (PAMFRI)
Palo Alto, United States· Recruiting
Stanford Cancer Center
Palo Alto, United States· Recruiting
Rocky Mountain Cancer Center
Aurora, United States· Recruiting
University of Miami Hospital and Clinics, Sylvester Cancer Center
Miami, United States· Recruiting
City of Hope National Medical Center, Atlanta Cancer Center
Newnan, United States· Recruiting
Mission Cancer + Blood
Waukee, United States· Recruiting
Saint Elizabeth Medical Center Edgewood
Edgewood, United States· Recruiting
American Oncology Partners, PA
Bethesda, United States· Recruiting
Boston Medical Center
Boston, United States· Recruiting

+119 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 both types of slow-growing cancer that affect certain white blood cells. They are very similar, but CLL is mainly found in the blood and bone marrow, while SLL is mostly in the lymph nodes.

What is a BTK inhibitor?

A BTK inhibitor is a type of medicine that targets a specific protein inside cancer cells (called Bruton's tyrosine kinase). By blocking this protein, these medicines can help slow down the growth and spread of CLL/SLL cells.

What is a '17p deletion'?

A '17p deletion' refers to a missing part of chromosome 17 in the cancer cells. This specific genetic change can sometimes make CLL/SLL more difficult to treat with standard therapies.

Is Pirtobrutinib an injection or a tablet?

Pirtobrutinib is designed to be taken as a tablet or capsule that you swallow, so you must be able to take oral medication to join the study.

How long will I be in the study if I join?

If you join Part 1 of the study (for previously treated CLL/SLL), you're expected to be in it for about 3 years. If you join Part 2 (for newly diagnosed, untreated CLL/SLL with a 17p deletion), your involvement is expected to last up to 2 years.

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.