Active not recruitingNAINTERVENTIONAL

RadiothErapy priMIng for CAR-T

The REMIT trial is studying a new approach for people in the UK with a type of blood cancer called Diffuse Large B Cell Lymphoma (DLBCL). This cancer has either returned after treatment or not responded to standard treatments. Patients will be receiving a special treatment called Tisagenlecleucel (a type of CAR-T cell therapy). The study wants to see if giving a small course of radiotherapy just before the CAR-T treatment helps make the CAR-T treatment more effective. Radiotherapy is currently used in some cases to prepare the body for CAR-T, and this study aims to understand if a specific way of giving it can improve outcomes for patients with DLBCL who are eligible for CAR-T therapy.

At a glance

Status

Active not recruiting

Phase

Sponsor

University College, London

Enrolment target

Start

18 Aug 2022

Estimated completion

30 Jun 2025

Diffuse Large B Cell Lymphoma

What is this study about?

This study, called the REMIT trial, is looking into how we can make a new type of treatment, called CAR-T cell therapy (specifically, Tisagenlecleucel), work even better for people in the UK with a blood cancer called Diffuse Large B Cell Lymphoma (DLBCL). This is for patients whose cancer has either come back after previous treatments or didn't respond well to them.

CAR-T cell therapy is a very advanced treatment where a patient's own immune cells are specially trained in a lab to fight their cancer. Before these new, trained cells are put back into the body, doctors often use other treatments, like chemotherapy or radiotherapy, to prepare the body. This study focuses on using radiotherapy as this 'preparation' step, or 'bridging method'. The aim is to see if targeted radiotherapy, given in a specific way, can help clear out some cancer cells and make the patient's body more ready for the CAR-T cells to do their job, potentially leading to better results.

The researchers want to find out if this particular way of using radiotherapy as a 'bridge' can improve how well CAR-T therapy works for people with DLBCL. This could eventually help more patients benefit from this important treatment.

Key takeaways

This study is for UK patients with DLBCL that has come back or not responded to previous treatments.
It combines radiotherapy with an advanced treatment called CAR-T cell therapy.
The goal is to see if radiotherapy before CAR-T makes the main treatment work better.
Participation involves screening, radiotherapy, CAR-T infusion, and follow-up for at least a year.
This is an important research study trying to improve cancer care.

Who may be eligible?

To join this study, you must be at least 18 years old and have been diagnosed with Diffuse Large B Cell Lymphoma (DLBCL), including certain types that have changed from other lymphomas. Your cancer needs to have come back or not responded after at least two other types of treatment, and your doctors must have decided that you are suitable for the Tisagenlecleucel CAR-T treatment.

You also need to be generally well enough to take part, meaning you can carry out most daily activities without too much difficulty. The cancer must be in a place where it can be measured on scans and where radiotherapy can be safely given. Lastly, you must be willing to follow all the study instructions, including any advice on contraception if needed.

You cannot join if you have had radiotherapy before in a way that would make this study's radiotherapy difficult, or if you are pregnant or breastfeeding. Also, if you’ve had other similar types of genetically modified cell treatments in the past, you might not be able to join, depending on the specifics.

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 or older?
Do you have Diffuse Large B Cell Lymphoma that has returned or not responded to at least two previous treatments?
Has your doctor said you are eligible for Tisagenlecleucel (CAR-T) treatment?
Is your cancer in a place that can be safely treated with radiotherapy?
Are you able to follow the study schedule and visits?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a screening phase that lasts up to 14 days. During this time, you'll have scans, like a PET-CT, to check your cancer. You'll also have a procedure called 'leukapheresis' where some of your blood cells are collected to make the CAR-T treatment.

Soon after your blood cells are collected, you will start radiotherapy. This will be given in different doses depending on where your cancer is located. Some areas will get a full dose over 5 to 15 visits, while other areas will get a lower dose over 2 visits. Then, about 14 to 21 days after your last radiotherapy, you will receive chemotherapy for a few days to prepare your body, followed by the CAR-T cell infusion.

After the CAR-T infusion, you will have follow-up appointments at 3 and 6 months to see how you are doing, and research staff will continue to check on your progress for at least 12 months after the infusion.

Potential risks and benefits

Taking part in this study might offer a potential benefit by seeing if this approach to radiotherapy makes the CAR-T treatment more effective for your cancer. However, as with any medical treatment, there are potential risks, including side effects from the radiotherapy, chemotherapy, and the CAR-T therapy itself. The study team will explain these risks in detail. You have the right to withdraw from the study at any time without giving a reason, and your medical care will not be affected.

Locations (3)

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

St James's University Hospital
Verified postcode
Leeds, United Kingdom
Kings College Hospital
Verified postcode
London, United Kingdom
Freeman Hospital
Verified postcode
Newcastle, United Kingdom

Common questions

What is Diffuse Large B Cell Lymphoma (DLBCL)?

It's a fast-growing type of blood cancer that affects certain white blood cells called lymphocytes.

What is CAR-T cell therapy?

It's a special treatment where your own immune cells are taken, modified in a lab to fight your cancer, and then put back into your body.

What is 'bridging radiotherapy'?

It's a short course of radiotherapy given to prepare your body and cancer cells before a main treatment like CAR-T therapy.

How long will I be followed up after treatment?

You'll be followed up for at least 12 months after receiving the CAR-T cells, with specific check-ups at 3 and 6 months.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time without affecting your usual medical care.