Active not recruitingPHASE3INTERVENTIONAL

A Phase III Trial Comparing Tisagenlecleucel to Standard of Care (SoC) in Adult Participants With r/r Follicular Lymphoma

This study is looking at adults with a type of blood cancer called follicular lymphoma (FL). This is for people whose lymphoma has either come back after treatment or hasn't responded well to previous treatments. The trial is comparing a new cell therapy, called tisagenlecleucel, to standard treatments that doctors usually offer for FL. The main goal is to find out if tisagenlecleucel can keep the lymphoma from growing or spreading for a longer time compared to current treatments. This research could help improve how we treat FL in the future. Participants will receive either the new cell therapy or one of the standard chemotherapy combinations.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Novartis Pharmaceuticals

Enrolment target

109

Start

02 Oct 2023

Estimated completion

20 Feb 2031

Follicular Lymphoma (FL)

What is this study about?

This study is for adults who have follicular lymphoma. This is a type of slow-growing cancer that affects white blood cells called lymphocytes. Doctors are particularly interested in patients whose lymphoma has returned after treatment or hasn't responded as hoped to earlier therapies. When cancer comes back or doesn't respond to treatment, it's called 'relapsed or refractory' (r/r) disease.

The main aim of this study is to compare a new type of therapy called tisagenlecleucel with the standard treatments currently used for this condition. Tisagenlecleucel is a special kind of 'CAR T-cell' therapy. This involves taking some of your own immune cells (T-cells), changing them in a lab so they can better find and fight cancer cells, and then giving them back to you.

We want to see if this new cell therapy can help keep the lymphoma under control for a longer period compared to standard treatments. This is important because it could offer a new and potentially more effective option for people with follicular lymphoma that is difficult to treat. By carefully comparing these treatments, researchers hope to improve future care for patients like you.

Key takeaways

This study compares a new cell therapy (tisagenlecleucel) with standard treatments for follicular lymphoma.
It's for adults whose lymphoma has returned or hasn't responded to previous therapies.
The main goal is to see if the new therapy keeps the lymphoma under control for longer.
You'll either get the new cell therapy or a standard chemotherapy combination.
Participation involves medical checks, scans, and treatments.
Your health will be closely monitored throughout the study.

Who may be eligible?

To join this study, you need to be at least 18 years old. You must have follicular lymphoma that has been confirmed by a doctor, and it needs to be the type that has either come back after at least two previous treatments or hasn't responded to them. Your lymphoma should also show up on special scans (like PET and CT scans).

There are also some important reasons why you might not be able to join. For example, if you have a more aggressive type of follicular lymphoma (grade 3B) or if it has changed into a different type of cancer. You also can't have had certain other cell therapies before or have the lymphoma affecting your brain or spine.

It's important that your overall health is good enough to receive treatment, and that you don't have certain serious infections like HIV or active hepatitis B or C. Your doctors will do checks to make sure your heart, lungs, kidneys, and liver are working well enough and that you meet all the necessary health requirements.

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.

Are you 18 years old or older?
Do you have follicular lymphoma that has come back or not responded to at least two previous treatments?
Is your lymphoma showing up on body scans (PET and CT)?
Have you NOT had certain other cell therapies before?
Do you feel well enough to participate (e.g., good energy level)?
Do you have healthy organ function (heart, lungs, kidneys, liver)?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be randomly assigned to one of two treatment groups, like flipping a coin. One group will receive the new cell therapy called tisagenlecleucel. This involves collecting some of your white blood cells (a process called leukapheresis), sending them away to be specially prepared, and then giving them back to you as a single infusion. Before the infusion, you might have some chemotherapy to prepare your body for the cell therapy.

The other group will receive standard treatments for follicular lymphoma, which could be either a combination of drugs called R2 (Lenalidomide and rituximab) given in cycles for up to a year, or another combination called R-CHOP (Rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) given in cycles for 6 to 8 months. The specific standard treatment will be decided by your doctor before you join.

Throughout the study, you will have regular visits for check-ups, blood tests, and scans to see how you are responding to treatment. The total duration of your participation, including treatment and follow-up, will be discussed in detail by the study team.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as access to a new therapy that might be more effective than current treatments for your follicular lymphoma. However, there are also potential risks involved, 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 future medical care.

Locations (30)

Novartis Investigative Site
Verified postcode
Camperdown, Australia
Novartis Investigative Site
Verified postcode
Clayton, Australia
Novartis Investigative Site
Verified postcode
Melbourne, Australia
Novartis Investigative Site
Verified postcode
Nedlands, Australia
Novartis Investigative Site
Verified postcode
Salzburg, Austria
Novartis Investigative Site
Verified postcode
Montreal, Canada
Novartis Investigative Site
Verified postcode
Ostrava, Czechia
Novartis Investigative Site
Verified postcode
Budapest, Hungary
Novartis Investigative Site
Verified postcode
Poznan, Poland
Novartis Investigative Site
Verified postcode
Gliwice, Poland
Novartis Investigative Site
Verified postcode
Gdansk, Poland
Novartis Investigative Site
Verified postcode
Lodz, Poland

Common questions

What is follicular lymphoma (FL)?

Follicular lymphoma is a type of slow-growing cancer that affects white blood cells called lymphocytes, which are part of your immune system.

What does 'relapsed or refractory' (r/r) mean?

This means your lymphoma has either come back after previous treatments or hasn't responded well to those treatments.

What is tisagenlecleucel therapy?

It's a special cell therapy where your own immune cells are changed in a lab to better fight your cancer, then given back to you.

Will I know which treatment I'm getting?

You'll be randomly assigned to either the new cell therapy or one of the standard treatments. Your doctor will explain which standard treatment you might receive if you're in that group.

What kind of tests will I have?

You'll likely have regular blood tests, physical exams, and scans like PET and CT scans to monitor your health and how the treatment is working.