Active not recruitingPHASE3INTERVENTIONAL

Study of LOXO-305 (Pirtobrutinib) Versus Investigator's Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab) in Patients With Previously Treated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

This research is for people living with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL), specifically those who have already had treatment with a type of drug called a BTK inhibitor. The main goal is to compare a new medicine, called LOXO-305 (Pirtobrutinib), with two standard treatment combinations: idelalisib plus rituximab, or bendamustine plus rituximab. We want to see if this new drug is more effective or safer. If you join, your participation could last up to four years, or even longer, if your condition remains stable. This is to gather important information that could help improve future treatments for CLL and SLL patients.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Loxo Oncology, Inc.

Enrolment target

238

Start

09 Mar 2021

Estimated completion

01 May 2027

Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

What is this study about?

This study is designed for individuals in the UK who have been diagnosed with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL). These are types of slow-growing cancers that affect white blood cells. This particular study is for people who have already received treatment for their condition, specifically a type of medication known as a BTK inhibitor. Sometimes, these previous treatments might stop working as well, or cause side effects that make them difficult to continue. This study aims to find out if a new drug, called Pirtobrutinib (also known as LOXO-305), could be a better option for these patients.

The main purpose of this research is to directly compare Pirtobrutinib with existing, commonly used treatments. Patients taking part will be randomly assigned to receive either Pirtobrutinib or one of two standard treatment combinations: idelalisib given with rituximab, or bendamustine given with rituximab. This comparison will help doctors understand if Pirtobrutinib is more effective at controlling the disease, causes fewer side effects, or offers a better quality of life compared to the current treatments.

Finding new and improved treatments is really important for people with CLL and SLL, especially when their condition has not responded well to previous therapies. While we can't promise specific results, studies like this help advance our understanding of these conditions and can lead to new medicines being made available in the future. Your involvement could make a real difference to others living with CLL and SLL.

Key takeaways

Looks at a new drug (Pirtobrutinib) for CLL/SLL.
For patients who have already had a BTK inhibitor.
Compares Pirtobrutinib to standard existing treatments.
Participation can last for several years, with regular check-ups.
You can leave the study at any time without affecting your care.

Who may be eligible?

To join this study, you must have a confirmed diagnosis of CLL or SLL and your doctor must agree that you need treatment. You also need to have received a BTK inhibitor drug in the past. This study is generally for adults aged 18 and over, of any gender. There are some health checks to make sure you're well enough to take part, including measures of your blood counts and how well your liver and kidneys are working. For example, your blood tests should show healthy enough levels of certain cells and that your organs are functioning properly.

However, some health conditions would mean you could not join. For instance, if you have certain other serious medical conditions like specific heart problems, a history of another type of cancer called Richter's transformation, or some ongoing infections (like active hepatitis B or C), this study might not be suitable for you. Also, if you've had a stem cell transplant or a specific type of advanced cell therapy (CAR-T) recently, you wouldn't be able to participate. The study team will carefully review all your medical information to confirm if you are eligible.

Quick self-check

Do I have a confirmed diagnosis of CLL or SLL?
Have I been treated with a BTK inhibitor before?
Am I generally well enough to manage hospital visits?
Do I have any serious heart conditions or active infections?
Have I had a recent stem cell or CAR-T transplant?

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

What does participation involve?

If you decide to join this study, you will first undergo several tests to ensure you fit the study's requirements. Once eligible, you will be randomly assigned to one of two groups: one receiving the new drug, Pirtobrutinib, and the other receiving a standard treatment combination. This is like flipping a coin, so neither you nor your doctor can choose which group you are in. All medications will be provided as part of the study.

You will have regular appointments at the hospital for check-ups, blood tests, and scans to see how you are responding to the treatment and to monitor for any side effects. The study team will tell you exactly how often these visits will be. Your participation could last for up to four years, or even longer if the treatment is helping to control your condition. After you stop taking the study medication, there will be follow-up calls or visits to check on your health and well-being.

Potential risks and benefits

Taking part in a clinical trial has potential benefits and risks. You might benefit from receiving a new treatment that could be more effective than current options, or from receiving standard care with close monitoring. However, there's no guarantee the treatment will work for you, and you might experience side effects, some of which could be serious or unexpected. The study team will discuss all known potential risks before you decide to join. Remember, your participation is completely voluntary, and you can withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (232)

Southern Cancer Center, P.C.
Daphne, United States
Mitchell Cancer Institute -University of South Alabama
Mobile, United States
Palo Verde Hematology Oncology
Glendale, United States
Arizona Oncology Associates, P.C. - HOPE
Tucson, United States
Orange Coast Memorial Medical Center
Fountain Valley, United States
California Research Institute
Los Angeles, United States
Rocky Mountain Cancer Center
Aurora, United States
Medical Oncology Hematology Consultants, PA
Newark, United States
Boca Raton Regional Hospital
Boca Raton, United States
Cancer Specialists of North Florida -St Augustine
Jacksonville, United States
Oncology-Hematology Associates of West Broward
Tamarac, United States
WellStar Health System
Marietta, United States

+220 more sites — see the official record for the full list.

Common questions

What is CLL/SLL?

CLL (Chronic Lymphocytic Leukaemia) and SLL (Small Lymphocytic Lymphoma) are slow-growing cancers that affect certain white blood cells.

What is a BTK inhibitor?

BTK inhibitors are a type of medication used to treat CLL and SLL by blocking a specific protein in cancer cells.

Will I know which treatment I'm getting?

Yes, this is an 'open-label' study, meaning you and your doctor will know whether you are receiving Pirtobrutinib or one of the standard treatments.

How long will I be in the study?

Your participation could last up to four years, or even longer if the treatment is controlling your condition well.

Can I stop participating at any time?

Yes, you can choose to leave the study at any point, and it won't affect your future medical care.