Active not recruitingPHASE3INTERVENTIONAL

Study of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Follicular Lymphoma

This research study is investigating a new treatment called axicabtagene ciloleucel for people who have follicular lymphoma that has either returned after initial treatment or hasn't responded to previous therapies. Follicular lymphoma is a type of slow-growing blood cancer. The study aims to compare this new treatment with standard treatments currently used. Researchers want to understand if axicabtagene ciloleucel can help people live longer or improve their condition more effectively than existing options. Participants will be carefully monitored to track the treatment's safety and effectiveness over a long period, which includes follow-up assessments for up to 15 years.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Kite, A Gilead Company

Enrolment target

231

Start

22 Sep 2022

Estimated completion

01 Oct 2030

Relapsed/Refractory Follicular Lymphoma

What is this study about?

This study is focused on a type of blood cancer called follicular lymphoma. Sometimes, after initial treatment, this type of lymphoma can return or not respond well to medicines. When this happens, doctors call it 'relapsed' or 'refractory' follicular lymphoma.

The main goal of this study is to look at a new treatment called axicabtagene ciloleucel. This treatment is a type of cell therapy. It’s being compared to the usual treatments that people with this condition might receive. The researchers want to find out if this new treatment works better, just as well, or differently from the standard care in controlling the lymphoma or improving how people feel.

By comparing these treatments, doctors hope to gain a clearer understanding of the best ways to help people with follicular lymphoma that has been difficult to treat. The information gathered from this study could help improve future care for many patients.

Key takeaways

This study is for follicular lymphoma that has returned or not responded to prior treatments.
It compares a new cell therapy (axicabtagene ciloleucel) with usual care.
Participation involves regular clinic visits and long-term follow-up (up to 15 years).
You will either receive the new treatment or a standard treatment, decided by chance.
Your health will be closely monitored throughout the study.

Who may be eligible?

To join this study, you would need to have follicular lymphoma (grades 1, 2, or 3a) that has either come back after your first treatment or hasn't responded to at least two previous treatments. Your doctor must also think you need treatment for your lymphoma right now, and they need to be able to measure your lymphoma to see if treatments are working. Important organs like your kidneys, liver, lungs, and heart also need to be working well.

There are also reasons why you might not be able to join. For example, if you have other specific types of lymphoma, if your lymphoma has spread to certain areas like your brain or spinal cord, or if you have a certain type of severe infection. If you've had similar cell therapies before, or have certain heart conditions or nerve damage, you might also not be able to take part. Women who are pregnant or breastfeeding cannot join, and both men and women must agree to use birth control during the study.

It's important to know that doctors will check a full list of conditions during the screening process to make sure the study is safe and appropriate for everyone involved.

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 follicular lymphoma that has relapsed or not responded to past treatments?
Am I at least 18 years old?
Are my kidneys, liver, lungs, and heart generally healthy?
Do I have active infections or a history of certain severe heart/nerve conditions?
Am I pregnant or breastfeeding, or unwilling to use birth control?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be given either the new treatment, axicabtagene ciloleucel, or one of the standard treatments for follicular lymphoma. These standard treatments can include medicines like lenalidomide, rituximab, cyclophosphamide, fludarabine, doxorubicin, vincristine, prednisone, or bendamustine. Which treatment you receive will be decided by chance, like flipping a coin. You will have regular visits to the clinic for assessments, including blood tests, scans, and check-ups to see how you are doing and how the treatment is working.

The study involves a long-term commitment. After the active treatment phase, even after five years, you will continue to be followed by the study team for up to 15 years. This long follow-up helps researchers understand the long-term effects and benefits of the treatments. You will have ongoing assessments and check-ins, though these may become less frequent over time. The total duration of your involvement could be up to 15 years.

Potential risks and benefits

Taking part in a clinical study means you might benefit from a new treatment option that isn't widely available yet, and you'll be closely monitored by medical professionals. Your participation could also help others in the future by improving understanding of follicular lymphoma treatments. However, there are potential risks, as any medicine can have side effects. Since axicabtagene ciloleucel is a new treatment, not all side effects are fully known, though researchers will tell you about common or serious ones they are aware of. Standard treatments also carry known risks and side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (52)

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

City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Verified postcode
Duarte, United States
Stanford Health Care
Verified postcode
Stanford, United States
Moffitt Cancer Center
Verified postcode
Tampa, United States
The University of Kansas Hospital
Verified postcode
Westwood, United States
University of Maryland Greenebaum Comprehensive Cancer Center
Verified postcode
Baltimore, United States
Dana-Farber Cancer Institute
Verified postcode
Boston, United States
Novant Health Cancer Institute Hematology - Charlotte
Verified postcode
Charlotte, United States
Penn State Milton S. Hershey Medical Center
Verified postcode
Hershey, United States
TriStar Centennial Medical Center - Cell Processing
Verified postcode
Nashville, United States
Henry-Joyce Cancer Clinic
Verified postcode
Nashville, United States
The University of Texas MD Anderson Cancer Center
Verified postcode
Houston, United States
Virginia Commonwealth University
Verified postcode
Richmond, United States

Common questions

What is follicular lymphoma?

Follicular lymphoma is a common type of slow-growing cancer that affects white blood cells called lymphocytes.

What does 'relapsed/refractory' mean?

It means your lymphoma has either come back after previous treatment or hasn't responded well to treatments you've had before.

What is axicabtagene ciloleucel?

It's a new type of treatment called cell therapy, which uses your own modified immune cells to fight the cancer.

How long will I be followed up after treatment?

You'll be followed by the study team for a long time, potentially up to 15 years, to monitor the long-term effects of the treatment.

Can I leave the study at any time?

Yes, you are free to leave the study at any point, and your decision will not affect your future medical care.