Active not recruitingPHASE3INTERVENTIONAL

Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL)

This research study is for people in the UK who have mantle cell lymphoma (MCL), a type of blood cancer. We are looking into a new medicine called pirtobrutinib. This drug works in a similar way to other treatments already approved by health bodies. The main aim is to see how pirtobrutinib compares to these existing medicines (like ibrutinib, acalabrutinib, or zanubrutinib) in patients who have already had at least one treatment for their MCL but haven't used this type of drug before. Participants could be in the study for up to two years, or even longer if their cancer doesn't get worse, allowing us to understand the long-term effects of the treatment.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Loxo Oncology, Inc.

Enrolment target

500

Start

08 Apr 2021

Estimated completion

01 Apr 2028

Lymphoma, Mantle-Cell

What is this study about?

This study is an important step in finding better ways to treat mantle cell lymphoma (MCL), a type of blood cancer. Many patients with MCL benefit from a group of medicines called BTK inhibitors. These drugs work by blocking a specific protein in cancer cells, which helps to stop the cancer from growing. There are already some approved BTK inhibitors available, and they have helped many people.

This study introduces a new drug called pirtobrutinib (also known as LOXO-305), which is also a BTK inhibitor. We want to see how pirtobrutinib compares to the existing, approved BTK inhibitors. We're particularly interested in patients who have already tried at least one other treatment for their MCL but haven't previously taken a BTK inhibitor. By comparing the new drug with established ones, we hope to learn if pirtobrutinib is a safe and effective new option for these patients.

This is a 'Phase 3' study, which means it's one of the final stages of testing a new medicine before it can potentially be approved for wider use. It's a randomised study, meaning participants will be randomly chosen to receive either pirtobrutinib or one of the existing treatments. This helps us to get reliable results about how well each treatment works. Your participation could help us improve treatment options for people with MCL in the future.

Key takeaways

Compares a new drug (pirtobrutinib) to existing approved treatments for MCL.
For adults with MCL who have had at least one prior treatment.
A 'Phase 3' study, which is a key step towards potential approval.
Close medical monitoring and support throughout the study.
Your participation could help improve future treatments for MCL.

Who may be eligible?

To join this study, you must have a confirmed diagnosis of mantle cell lymphoma (MCL) and have already received at least one course of treatment for it. Your lymphomamust be measurable, meaning doctors can track its size. You also need to be generally well enough to take part, as assessed by your doctor, and have certain blood test results within a healthy range, including your blood cell counts, liver function, and kidney function.

There are also some reasons why you might not be able to join. For example, if you've already had a BTK inhibitor drug, which is the type of drug being studied, then this trial wouldn't be suitable for you. If you've recently had a stroke or certain types of stem cell or CAR-T cell transplant, or have some serious heart conditions, these would also prevent you from participating. Additionally, certain infections, significant bleeding problems, or issues with absorbing medicines might mean you can't join. Your doctor will carefully review all your health information to see if this study is right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do I have a confirmed diagnosis of Mantle Cell Lymphoma (MCL)?
Have I already received at least one prior treatment for my MCL?
Have I *never* taken a BTK inhibitor drug (like ibrutinib, acalabrutinib, or zanubrutinib) before?
Am I generally well enough for a clinical trial, based on my doctor's assessment?
Do I have healthy enough blood counts and organ function (liver, kidney)?

Answer every question to see your result.

What does participation involve?

If you join this study, it could last for about two years, and possibly longer if the treatment is helping you. You will be randomly assigned to receive either the new drug, pirtobrutinib, or one of the approved BTK inhibitors (ibrutinib, acalabrutinib, or zanubrutinib). You will take the study medication as prescribed by the research team. Throughout the study, you'll have regular hospital visits for check-ups, blood tests, and scans to see how you're responding to the treatment and to monitor your health. These visits will help the medical team track your progress, manage any side effects, and ensure your safety. You'll be closely supported by the study team throughout your involvement.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as accessing a new treatment (pirtobrutinib) that isn't yet widely available, or receiving one of the standard approved treatments under close medical supervision. However, like all medications, both the new drug and the approved ones carry potential risks and side effects, some of which could be serious. All potential side effects will be fully explained to you by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (189)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Alaska Oncology and Hematology, LLC
Verified postcode
Anchorage, United States
Arizona Oncology Associates, P.C. - HOPE
Verified postcode
Phoenix, United States
UCLA Medical Center
Verified postcode
Los Angeles, United States
USO-Rocky Mountain Cancer Center
Verified postcode
Denver, United States
Mayo Clinic in Florida
Verified postcode
Jacksonville, United States
Oncology-Hematology Associates of West Broward
Verified postcode
Tamarac, United States
Florida Cancer Specialists East
Verified postcode
West Palm Beach, United States
University of Kentucky Markey Cancer Center
Verified postcode
Lexington, United States
Mercy Health-Paducah Medical Oncology and Hematology
Verified postcode
Paducah, United States
Tulane Cancer Center Office of Clinical Research
Verified postcode
New Orleans, United States
Greenebaum Comprehensive Cancer Center
Verified postcode
Baltimore, United States
DFCI Lymphoma
Verified postcode
Boston, United States

Common questions

What is Mantle Cell Lymphoma (MCL)?

MCL is a rare type of cancer that affects white blood cells called lymphocytes, which are part of your immune system. It can affect your lymph nodes, spleen, blood, and bone marrow.

What is pirtobrutinib (LOXO-305)?

Pirtobrutinib is an experimental drug designed to treat certain blood cancers, including MCL. It's a 'BTK inhibitor,' meaning it blocks a specific protein in cancer cells to stop them from growing.

What does 'Phase 3' mean for a study?

Phase 3 is a late stage of clinical research where a new drug is compared to existing treatments or a placebo in a large group of people. This helps confirm its effectiveness and monitor side effects before it can be approved.

Will I know which treatment I'm getting?

Yes, this is an 'open-label' study. This means both you and your doctor will know whether you are receiving pirtobrutinib or one of the other approved BTK inhibitor drugs.

How long will I be in the study?

Participation can last up to two years, and potentially longer if the treatment is working well for you and your cancer doesn't get worse.