Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Axicabtagene Ciloleucel CAR T-Cells in Patients with relapsed or refractory primary mediastinal B-Cell Lymphoma

This research study is investigating a treatment called axicabtagene ciloleucel, also known as Yescarta. This is a type of CAR T-cell therapy. It's being tested in adults who have a specific kind of blood cancer called primary mediastinal B-cell lymphoma (PMBCL). This is for people whose cancer has come back or hasn't responded to other treatments. The main goal is to find out if this treatment can completely clear the cancer at a three-month check-up using special scans (PET-CT or PET-MRI). This study is in an early stage (Phase II), meaning it's still exploring how well the treatment works and its safety in a small group of patients. It's a way to investigate new ways to fight this type of lymphoma.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Universitaet Muenster

Enrolment target

Start

07 Feb 2025

Primary mediastinal large B-cell lymphoma (PMBCL)

What is this study about?

This study is focusing on a specific type of cancer called primary mediastinal large B-cell lymphoma (PMBCL). This is a rare type of fast-growing lymphoma that starts in white blood cells in an area of the chest called the mediastinum. For some people, standard treatments might not work, or the cancer might come back. That's why researchers are looking for new and effective ways to treat it.

The treatment being studied is called axicabtagene ciloleucel, also known by its brand name, Yescarta. This is a very advanced type of treatment called CAR T-cell therapy. In simple terms, it involves taking some of a patient's own immune cells (T-cells), modifying them in a lab so they are better at recognising and fighting cancer, and then giving them back to the patient. It's like giving your own immune system a special upgrade to target the cancer cells.

The main aim of this study is to see how many people achieve a complete clearance of their cancer three months after receiving the Yescarta treatment. This clearance will be checked using special body scans like PET-CT or PET-MRI, which help doctors see if cancer cells are still present and active. This will help doctors understand how effective this treatment is for people with PMBCL whose cancer has been difficult to treat.

Key takeaways

This study is testing a new cell therapy (Yescarta) for a specific lymphoma.
It's for adults whose primary mediastinal B-cell lymphoma has returned or hasn't responded to previous treatment.
The main goal is to see if the treatment can clear the cancer after three months.
Participation involves a single treatment but long-term follow-up appointments.
There are potential benefits and risks, which your doctor will discuss.
You can withdraw from the study at any time.

Who may be eligible?

To be considered for this study, you need to be an adult, meaning you must be 18 years old or older. There is no upper age limit for taking part. Both men and women are welcome to participate in the study.

The study is specifically for individuals who have primary mediastinal large B-cell lymphoma (PMBCL). Importantly, your cancer must be described as "relapsed" (meaning it has come back after treatment) or "refractory" (meaning it has not responded to previous treatments). This study is not for people recently diagnosed with PMBCL or whose cancer has responded well to their initial treatments.

There will be other medical checks and criteria that a study doctor will need to go through with you to make sure this study is safe and suitable for your specific health 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 primary mediastinal B-cell lymphoma (PMBCL)?
Has your PMBCL come back or not responded to previous treatments?
Are you able to attend regular medical appointments and scans?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive a single infusion of the study treatment, Yescarta. This involves placing treated cells directly into your bloodstream, similar to a blood transfusion. Before the infusion, you will have several appointments for tests and to prepare your body for the treatment. Afterwards, you will have regular medical appointments, including physical examinations and special scans like PET-CT or PET-MRI, to check how you are responding to the treatment and to monitor your health.

The study will follow your progress closely, especially in the first few months after the treatment, to see if the cancer has cleared. You will also have follow-up appointments over a longer period to understand the long-term effects of the treatment and to see if the cancer stays away. The total duration of your involvement could be several years, as researchers need to monitor participants for a longer time after this type of therapy.

Potential risks and benefits

Taking part in any clinical trial involves potential benefits and risks. A potential benefit of this study is that you might gain access to a new, advanced treatment (Yescarta) that may help clear your primary mediastinal B-cell lymphoma, especially if other treatments haven't worked for you. However, there are also potential risks. CAR T-cell therapy can cause side effects, some of which can be serious and require close monitoring and treatment in the hospital. Your medical team will explain all the known side effects in detail. It's important to remember that participation is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

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

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Unverified
Germany

Common questions

What is CAR T-cell therapy?

CAR T-cell therapy is a treatment where your own immune cells are modified in a lab to better fight your cancer, then put back into your body.

Who is this study for?

This study is for adults (18+) with a specific type of lymphoma called primary mediastinal B-cell lymphoma that has come back or hasn't responded to other treatments.

What is Yescarta?

Yescarta is the name of the specific CAR T-cell therapy being tested in this study.

How long will I be involved in the study?

Your involvement could last for several years, as doctors need to track your health and the treatment's effects over a longer period.

Can I stop participating if I want to?

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