Double-T - Improving outcomes in high-risk 2nd line relapsed/refractory Large B-Cell Lymphoma patients eligible for CAR-T-cell therapy with a Glofitamab-based induction and consolidation concept
This study, called 'Double-T', is for people with Large B-Cell Lymphoma, a type of blood cancer, that has either returned after initial treatment or hasn't responded well to standard therapies. It's a Phase II trial, meaning it's testing if these treatments are safe and if they work. The main goal is to see how many patients achieve a complete response, where there are no signs of the cancer left, after receiving a new combination of treatments. These treatments include a medicine called Glofitamab, and a specialised cell therapy called CAR-T cell therapy. We also want to understand how long the benefits last and what the overall experience is like for patients, including any side effects and their quality of life.
At a glance
What is this study about?
This study is looking into a new treatment approach for a type of blood cancer called Large B-Cell Lymphoma, specifically for patients whose cancer has come back (relapsed) or hasn't responded to earlier treatments (refractory). These patients are usually considered to have 'high-risk' disease.
The trial aims to improve outcomes for these patients who are already suitable for a treatment known as CAR-T cell therapy. CAR-T cell therapy is a highly advanced treatment where a patient's own immune cells are specially trained in a lab to find and destroy cancer cells. In this study, researchers are combining CAR-T cell therapy with a new medicine called Glofitamab, in an effort to make the CAR-T cell therapy even more effective. They believe this combination, used both before (induction) and after (consolidation) the CAR-T cells, could lead to better results.
The main thing the researchers want to find out is the 'complete response rate'. This means how many patients have no signs of cancer left after the treatment finishes. They will also be looking at how long people stay in remission, their overall survival, and how the CAR-T cells behave in the body. Importantly, they will also closely monitor for any side effects and assess the patient's quality of life throughout the study, to make sure the treatment is not only effective but also manageable.
Key takeaways
- Targets a fast-growing blood cancer called Large B-Cell Lymphoma.
- For patients whose cancer has returned or didn't respond to usual treatments.
- Combines CAR-T cell therapy with a new drug, Glofitamab.
- Aims to achieve a complete response, meaning no visible cancer.
- Closely monitors safety, side effects, and overall well-being.
- This is a Phase II study, checking both safety and effectiveness.
Who may be eligible?
To join this study, you generally need to be an adult, aged 18 years or older.
The study is specifically for people who have been diagnosed with Large B-Cell Lymphoma that has either returned after previous treatment or hasn't responded well to the usual treatments. You must also be considered a suitable candidate for CAR-T cell therapy by your doctor.
There might be other health conditions or previous treatments that could mean you can't take part. These details would be discussed with you by your medical team to ensure the study is safe and appropriate for your individual situation.
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 relapsed or refractory Large B-Cell Lymphoma?
- Has your doctor said you might be suitable for CAR-T cell therapy?
- Are you able to attend regular hospital visits and appointments?
What does participation involve?
If you decide to take part in this study, you would receive a combination of treatments over a period of time. This includes infusions of medicines like Columvi and Gazyvaro, followed by CAR-T cell therapy (Breyanzi or YESCARTA), and then potentially more Glofitamab doses.
Throughout the study, you would come in for regular hospital visits. These visits would involve various assessments, such as physical examinations, blood tests, and scans, to check how you are responding to the treatment and to monitor for any side effects. Researchers will also be looking at your immune cells and how the CAR-T cells behave in your body. Your quality of life will be checked using questionnaires. The total duration of your participation, including follow-up appointments, would be explained to you in detail by the study team.
Potential risks and benefits
Locations (1)
- —UnverifiedGermany
Common questions
What is Large B-Cell Lymphoma?
It's a fast-growing type of blood cancer that affects infection-fighting white blood cells called lymphocytes.
What is CAR-T cell therapy?
It's a treatment where a patient's own immune cells are specially trained to find and kill cancer cells.
What does 'relapsed/refractory' mean?
It means the cancer has come back after treatment, or it didn't respond well to previous treatments.
What is a 'complete response'?
This means that tests show no signs of the cancer remaining after treatment.
Is this a new treatment?
Yes, this study is testing a new combination of existing medicines and CAR-T cell therapy to see if it works better.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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