Active not recruitingPHASE3INTERVENTIONAL

Study to Compare Axicabtagene Ciloleucel With Standard of Care Therapy as First-line Treatment in Participants With High-risk Large B-cell Lymphoma

This research study is looking at a new treatment called axicabtagene ciloleucel for adults who have recently been diagnosed with a type of blood cancer called high-risk large B-cell lymphoma. This new treatment is being compared to the usual care you might receive (standard of care). The main goal is to find out if axicabtagene ciloleucel is a more effective first treatment for this specific type of lymphoma. Participants will be carefully monitored for a long time, up to 15 years, to understand the long-term effects and benefits of the treatments. Your participation could help improve future treatments for people with this condition.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Kite, A Gilead Company

Enrolment target

300

Start

10 Feb 2023

Estimated completion

01 Mar 2031

High-risk Large B-cell Lymphoma (LBCL)

What is this study about?

This study is for adults who have recently been diagnosed with a serious type of blood cancer called high-risk large B-cell lymphoma. It's a randomised study, which means that people taking part will be put into one of two groups by chance. One group will receive a new treatment called axicabtagene ciloleucel, while the other group will receive the standard treatment that doctors usually offer for this condition. The main aim is to see if the new treatment works better or as well as the standard treatment.

Doctors want to find out the best way to treat this high-risk type of lymphoma right from the start. By comparing the new treatment with existing options, researchers hope to improve how patients like you are cared for in the future. This study focuses on what happens when these treatments are used as the very first approach, rather than after other treatments have failed.

Because we need to understand the full impact of these treatments, participants will be followed up for a very long time – up to 15 years. This long-term monitoring will help doctors learn about the lasting effects and benefits, ensuring we get a complete picture of how well the treatments work and if there are any long-term side effects. Your involvement could make a real difference in helping others with large B-cell lymphoma.

Key takeaways

This study compares a new treatment with standard care for high-risk large B-cell lymphoma.
It's for adults recently diagnosed who have had only one round of standard chemotherapy.
Participants will be randomly assigned to receive either the new or standard treatment.
The study involves regular clinic visits, tests, and long-term health monitoring (up to 15 years).
It aims to find better first-line treatments for this aggressive lymphoma.
Your participation could help improve future patient care.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older, and have a confirmed diagnosis of high-risk large B-cell lymphoma. This diagnosis must be based on specific types established by medical guidelines, such as diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL). You also need to have received only one round of a specific chemotherapy treatment called R-chemotherapy as your very first treatment.

It's important that your body is generally healthy enough to participate. This means your bone marrow, kidneys, liver, lungs, and heart should be working well. If you are a woman who could become pregnant, you'll need to have a negative pregnancy test before starting.

There are some reasons why you might not be able to join. For example, certain other types of lymphoma or if your lymphoma has spread to your brain or spinal fluid would prevent participation. Also, if you've already had more than one round of R-chemotherapy, or have serious heart conditions or certain infections like active hepatitis B or C, or uncontrolled HIV, you wouldn't be eligible for this study.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with high-risk large B-cell lymphoma?
Have you only had one cycle of R-chemotherapy so far for your lymphoma?
Are your major organs (heart, lungs, kidneys, liver) generally healthy?
Are you free from certain other serious health conditions, specific types of lymphoma, or active infections?
If you are a woman of childbearing potential, are you able to have a negative pregnancy test?

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 will be randomly assigned to receive either the new study drug or the standard treatment. The treatments involve various medications. You will have regular visits to the clinic for medical check-ups, blood tests, and scans to monitor your health and how well the treatment is working. Some participants will be followed for a very long time, up to 15 years, during which you will have scheduled appointments to assess your health and the long-term effects of the treatment. The total duration of your active treatment phase will vary, but the long-term monitoring is crucial for the study.

Potential risks and benefits

Potential benefits of joining include receiving a new experimental treatment that might be more effective than current standard options, and contributing valuable information that could help others in the future. However, there are potential risks, as all medical treatments can have side effects. These will be fully explained by the study team, and you will be closely monitored for any reactions. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (85)

University of Alabama Hospital
Birmingham, United States
Banner MD Anderson Cancer Center
Gilbert, United States
Mayo Clinic
Phoenix, United States
UC San Diego Moores Cancer Center
La Jolla, United States
University of California Los Angeles (UCLA)
Los Angeles, United States
Colorado Blood Cancer Institute
Denver, United States
Moffitt Cancer Center
Tampa, United States
Georgia Cancer Center at Augusta University
Augusta, United States
Northwestern Memorial Hospital
Chicago, United States
University of Chicago Medical Center
Chicago, United States
University of Iowa
Iowa City, United States
The University of Kansas Hospital
Westwood, United States

+73 more sites — see the official record for the full list.

Common questions

What is 'high-risk large B-cell lymphoma'?

It's a serious type of blood cancer that starts in certain white blood cells. 'High-risk' means it's more aggressive and needs careful treatment.

What is 'axicabtagene ciloleucel'?

It's a new type of treatment, sometimes called gene therapy, where your own immune cells are specially modified in the lab to fight the cancer.

What does 'standard of care' mean?

This refers to the best and most common treatments that doctors currently use for this type of lymphoma, which often involves chemotherapy and other drugs.

Will I know which treatment I'm getting?

No, in a 'randomised' study like this, you won't know initially whether you're receiving the new treatment or the standard one. This helps ensure the study results are fair.

Why is the follow-up so long?

A long follow-up of up to 15 years helps doctors understand the treatment's long-term effects, how well it keeps the cancer away, and any potential side effects that might appear later.