Active not recruitingPHASE3INTERVENTIONAL

A Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) Versus Venetoclax and Rituximab (VR) in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

This study is looking at a new combination treatment for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Both are types of cancer affecting white blood cells. If you’ve already had treatment for CLL or SLL, you might be able to join. The study compares two treatment plans: one group gets an investigational drug called Pirtobrutinib along with Venetoclax and Rituximab, while the other group gets only Venetoclax and Rituximab, which are standard treatments. The main goal is to find out if adding Pirtobrutinib makes the treatment more effective and safe. Participants will be monitored for up to five years.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Loxo Oncology, Inc.

Enrolment target

600

Start

20 Sep 2021

Estimated completion

01 Oct 2027

Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

What is this study about?

This clinical trial is designed for people living in the UK who have been diagnosed with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). These are slow-growing cancers of certain white blood cells. If you've already received treatment for your condition at least once, this study might be relevant to you. The trial aims to find a better way to treat these conditions.

The study will involve two main treatment approaches. Some participants will receive a combination of three drugs: Pirtobrutinib (which is an investigational drug, meaning it's still being studied), along with Venetoclax and Rituximab (which are already approved treatments). Another group of participants will receive only Venetoclax and Rituximab. By comparing these two groups, doctors hope to understand if adding Pirtobrutinib makes the treatment more effective at controlling the cancer and is also safe for patients.

This kind of research, called a Phase 3 trial, is a very important step to determine if new treatments are better than existing ones. If the new combination proves to be more effective and safe, it could become a new standard treatment option for people with CLL or SLL in the future. The trial will carefully monitor participants over several years, up to five, to gather all the necessary information.

Key takeaways

This study is for UK patients with CLL/SLL who have already been treated at least once.
It compares a new drug (Pirtobrutinib) combined with standard drugs against standard drugs alone.
The goal is to find out if the new combination is more effective and safe.
Participation could involve up to five years of monitoring.
You will receive regular check-ups and medical care throughout the study.

Who may be eligible?

To join this study, doctors will first check if you meet certain criteria. You must have a confirmed diagnosis of CLL or SLL and have already received at least one course of treatment for your condition. This could include a specific type of drug called a 'BTK inhibitor'. Your blood tests, such as platelet count, red blood cell count (hemoglobin), and certain white blood cells, need to be within a healthy range, and your body organs must be working well.

There are also reasons why someone might not be able to join. For example, if your cancer has changed into a more aggressive type called Richter's transformation, or if you've already had a specific type of BTK inhibitor that works differently than the one being studied. Other reasons include needing blood thinners like warfarin, having certain heart problems, or having active severe infections like HIV or hepatitis. You also can't have received a live vaccine recently or have had certain complex treatments or transplants within the last couple of months.

The research team will carefully review all your medical information to decide if this study is right for you. It's important that you discuss all your health conditions and medications with them, so they can make the best decision for your safety and the study's accuracy.

Quick self-check

Have you been diagnosed with CLL or SLL?
Have you received treatment for your CLL or SLL before?
Are your general blood test results (like platelets, red cells, white cells) usually within a healthy range?
Are your major organs (like liver and kidneys) working well?
Do you have good overall daily function and energy levels?
Are you 18 years old or older?

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, you'll be assigned to one of two treatment groups: either Pirtobrutinib plus Venetoclax and Rituximab, or Venetoclax and Rituximab alone. The researchers will not choose which group you are in; it will be random, like flipping a coin. You will receive your study medication as prescribed by the study doctors.

Throughout the study, you'll have regular hospital or clinic visits. These visits will involve various tests, such as blood tests to check your blood counts and how your body is responding to the treatment, and possibly scans to see the effect on your CLL/SLL. The healthcare team will also ask you about any side effects you might be experiencing and how you are feeling generally. These check-ups are crucial for monitoring your health and the effectiveness of the treatment.

Your participation in the study could last for up to five years. This includes the period while you are receiving treatment and also a follow-up period to understand the long-term effects of the treatments. You'll be given all the specific details about the schedule of visits and procedures if you qualify and decide to join the study.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. You might benefit from closer medical attention and potentially receive a new treatment (Pirtobrutinib) that could be more effective than existing options for your condition. However, there's also a chance that the new treatment may not work for you, or it might cause side effects that are unexpected or serious. Every medication, including standard care, carries risks. The research team will explain all known potential side effects of the drugs involved. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care, and your doctors will continue to support you.

Locations (176)

Ironwood Physicians, Ironwood Cancer and Research Centers
Chandler, United States
Mayo Clinic Hospital
Phoenix, United States
University of California Irvine Medical Center
Orange, United States
Scripps Mercy Hospital
San Diego, United States
Providence Medical Foundation
Santa Rosa, United States
Stamford Hospital
Stamford, United States
Florida Cancer Specialists
Fort Myers, United States
Cancer Specialists of North Florida -St Augustine
Saint Augustine, United States
Florida Cancer Specialists East
West Palm Beach, United States
Mission Cancer and Blood
Des Moines, United States
Pikeville Medical Center, Inc.
Pikeville, United States
American Oncology Partners of Maryland, PA
Bethesda, United States

+164 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 types of cancer that affect the white blood cells in your body.

What is Pirtobrutinib?

Pirtobrutinib is a new drug being tested in this study. It's not yet approved for general use but is being investigated for its potential to treat CLL/SLL.

Why is this study important?

This study aims to find out if adding Pirtobrutinib to standard treatments can make them more effective and safe for people with CLL/SLL who have had previous treatment.

How long would I be in the study?

Your participation in the study could last for up to five years, including both active treatment and follow-up periods.

Can I choose which treatment I get?

No, you cannot choose. You would be randomly assigned to one of the two treatment groups, similar to drawing lots, ensuring a fair comparison.