Active not recruitingNAINTERVENTIONAL

Real-Time Monitoring of Circulating Tumor DNA and Study of Prognostic Factors in Patients Treated With CAR-T Cells

This study aims to make it quicker to see if diffuse large B-cell lymphoma is coming back after patients have been treated with CAR-T cells. Researchers are testing a method that looks for tiny fragments of cancer DNA in the blood, called circulating tumour DNA (ctDNA). They want to see if they can get these test results to doctors within three weeks of the CAR-T treatment. If successful, this quicker information could help doctors identify patients whose disease might be returning sooner. This early warning could mean patients get additional or different treatments more quickly, which might improve their chances of a better outcome. The study is checking if it's practical to deliver these timely results.

At a glance

Status

Active not recruiting

Phase

Sponsor

Centre Henri Becquerel

Enrolment target

Start

13 Jan 2023

Estimated completion

08 Sep 2026

Diffuse Large B Cell Lymphoma

What is this study about?

This study is about making sure patients with a type of blood cancer called diffuse large B-cell lymphoma (DLBCL) get the best possible care after a powerful treatment called CAR-T cell therapy. For some patients, CAR-T cells can successfully fight the cancer. However, sometimes, the cancer can return.

Currently, doctors often use a type of scan called a PET-CT scan to see how well the treatment has worked and if the cancer has gone or is coming back. This study is exploring a new, faster way to check for any remaining or returning cancer cells. They do this by looking for tiny pieces of cancer DNA that circulate in the blood, known as circulating tumour DNA (ctDNA). The goal is to see if they can get these ctDNA test results to doctors much faster – within three weeks of the CAR-T treatment.

Imagine if doctors could know much sooner if the cancer might be returning. This study aims to show that it's possible to get this information quickly. If successful, this quicker insight could allow doctors to offer extra treatments earlier, potentially giving patients a better chance of staying well. It's about finding ways to monitor patients more effectively and respond faster if needed.

Key takeaways

The study explores a faster way to monitor lymphoma after CAR-T therapy.
It uses blood samples to find tiny cancer DNA fragments (ctDNA).
The goal is to provide results to doctors within three weeks of treatment.
Earlier information could help doctors plan additional treatments sooner.
This is a monitoring study, not a change to your CAR-T treatment itself.

Who may be eligible?

To be part of this study, you need to be at least 18 years old and have a specific type of lymphoma called diffuse large B-cell lymphoma (DLBCL) that has either come back or not responded to previous treatments. You must also be scheduled to receive CAR-T cell therapy specifically for this type of lymphoma, and have a recent PET-CT scan before your CAR-T treatment.

Certain things would mean you couldn't join the study. For example, if you are pregnant or breastfeeding, or if the stored samples of your cancer cells from a previous biopsy aren't suitable for special testing. You also wouldn't be able to join if you are already taking part in another clinical trial for CAR-T cell treatment, if you weigh less than 30 kg, or if you couldn't understand what the study involves or commit to its requirements.

Overall, the study is looking for adults with relapsed or refractory DLBCL who are receiving standard CAR-T cell therapy and are able to provide consent and follow the study plan. The main focus is on monitoring your cancer using new blood tests alongside your regular treatment.

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 (DLBCL) that has returned or not responded to previous treatments?
Are you scheduled to receive CAR-T cell therapy for your DLBCL?
Can you provide a blood sample around 7 days after your CAR-T treatment?
Are you not pregnant or breastfeeding, and not already in another CAR-T clinical trial?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, your involvement would mainly revolve around providing blood samples at specific times during your CAR-T cell treatment. The key blood sample will be taken around seven days after you receive your CAR-T cells. This is to check for tiny bits of cancer DNA in your blood. These samples are collected alongside your routine medical care and check-ups. There are no extra medications or treatments involved solely because of this study. Your doctors will continue to assess your condition with standard tests, including a PET-CT scan around 28 days after your CAR-T treatment. The study's aim is to see if the blood test results can be delivered quickly to your doctor, so there won't be significant additional appointments; rather, it’s about collecting and analysing information from existing appointments. The total duration of your participation in this monitoring aspect of the study would be approximately one month, focusing on the period immediately following your CAR-T cell infusion.

Potential risks and benefits

The potential benefits of taking part in this study don't directly change your treatment, as it's a monitoring study. However, by helping to show that this faster blood test method works, you could be contributing to future improvements in how doctors monitor lymphoma. This might lead to earlier detection of cancer recurrence and quicker decisions about further treatment for patients in the future. As for risks, providing the blood samples is generally very safe, with only minor temporary discomfort or bruising from the blood draw. There are no experimental treatments involved. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

Centre Henri Becquerel
Verified postcode
Rouen, France

Common questions

What is CAR-T cell therapy?

CAR-T cell therapy is a special type of treatment where a patient's own immune cells are modified in a lab to better find and kill cancer cells, and then given back to the patient.

What is 'circulating tumour DNA' (ctDNA)?

CtDNA are tiny fragments of DNA released by cancer cells into the bloodstream. Finding these bits can be a sign that cancer cells are present in the body.

Why is 'real-time' monitoring important?

Real-time monitoring means getting test results quickly. In this study, it's about getting blood test results fast enough to potentially help doctors make treatment decisions sooner if the cancer is returning.

Will I get different treatment if I join this study?

No, this study is about monitoring, not changing your treatment. You will receive the standard CAR-T cell therapy for your condition. The study aims to make monitoring faster in the future.

What will I have to do if I participate?

Mainly, you'll provide an extra blood sample around seven days after your CAR-T cell treatment. This is in addition to your standard medical check-ups and tests.