Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A PHASE 2 MULTICENTER STUDY OF AXICABTAGENE CILOLEUCEL IN SUBJECTS WITH RELAPSED/REFRACTORY INDOLENT NON-HODGKIN LYMPHOMA (INHL)

This study is investigating a new cell treatment called Yescarta (also known as axicabtagene ciloleucel) for adults who have slow-growing non-Hodgkin lymphoma, specifically Fullicular Lymphoma or Marginal Zone Lymphoma. This treatment is for people whose lymphoma has returned after previous treatments or hasn't responded to them. Researchers want to see how effective Yescarta is at shrinking the cancer and how long that effect lasts, over a period of up to 15 years. They are also carefully monitoring any side effects and how participants feel throughout the study. The aim is to understand if this advanced cell therapy can offer a new and effective option for these types of lymphoma.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Kite Pharma Inc.

Enrolment target

Start

26 Sep 2023

Follicular Lymphoma, Marginal Zone Lymphoma, Indolent Non-Hodgkin Lymphoma

What is this study about?

This research study is looking into a special kind of treatment called Yescarta. It's a type of 'cell therapy' or 'CAR T-cell therapy'. This treatment involves taking some of a patient's own immune cells, called T-cells, and reprogramming them in a lab to better find and fight cancer cells. Once these super-charged cells are ready, they are given back to the patient through an infusion, similar to a blood transfusion.

The study focuses on adults who have certain types of slow-growing non-Hodgkin lymphoma, such as Follicular Lymphoma or Marginal Zone Lymphoma. These are cancers that affect a type of white blood cell. The Yescarta treatment is being tested in people whose lymphoma has either come back after past treatments or hasn't responded as hoped to other medicines.

The main goals of this study are to find out how many patients respond to the treatment, meaning their cancer shrinks or disappears, and how long that response lasts. Researchers will follow participants for a long time, up to 15 years, to get a very clear picture of the treatment's long-term effects and safety. They are also looking at how the treatment affects quality of life and any side effects.

Key takeaways

This study explores a new cell therapy (Yescarta) for certain slow-growing lymphomas.
It's for people whose lymphoma has returned or didn't respond to other treatments.
Researchers will follow participants for up to 15 years to check effectiveness and safety.
The treatment involves using your own specially modified immune cells.
Various medications are given alongside Yescarta to prepare the body and manage side effects.

Who may be eligible?

This study is looking for adult participants, aged 18 or older. There is no upper age limit for joining.

To be considered for this study, you must have been diagnosed with a specific type of slow-growing non-Hodgkin lymphoma, either Follicular Lymphoma or Marginal Zone Lymphoma. It's important that your cancer has either returned after you've had other treatments, or that those past treatments haven't worked well for you.

There will be other, more detailed medical checks to make sure this study is right and safe for you. These might include reviewing your general health, blood test results, and details of past treatments you've received for your lymphoma.

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 a diagnosis of Follicular Lymphoma or Marginal Zone Lymphoma?
Has your lymphoma come back after previous treatments?
Has your lymphoma not responded well to treatments you've already had?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll receive the Yescarta treatment along with other medications that help prepare your body for the cell therapy or manage potential side effects, such as pain relief (paracetamol), medicines to help with reactions (diphenhydramine, tocilizumab) and anti-inflammatory drugs (dexamethasone, methylprednisolone). You might also receive chemotherapy drugs like fludarabine, cyclophosphamide, and mesna as part of the preparation.

Your involvement will include regular check-ups and assessments, which involve blood tests at specific times (like day 7, week 2, month 3, and then less often) to monitor the new cells and your general health. You'll also have scans or other tests to see how the cancer is responding to the treatment. This follow-up will continue for a significant period, up to 15 years, to understand the long-term effects of the treatment. Each visit will be explained in detail by the study team.

Potential risks and benefits

Participating in this study might offer the potential benefit of a new and advanced treatment for your type of lymphoma, especially if other treatments haven't worked. It could lead to your cancer shrinking or even disappearing. However, like all medical treatments, Yescarta and the other medications used carry potential risks and side effects, some of which can be serious. The study team will explain these in detail, and you'll be closely monitored for any reactions. You are free to withdraw from the study at any time, for any reason, without it affecting your usual 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
France

Common questions

What is Yescarta?

Yescarta is a special type of cell therapy where your own immune cells are changed in a lab to fight your cancer better.

What types of lymphoma is this study for?

This study is for adults with Follicular Lymphoma or Marginal Zone Lymphoma, which are types of slow-growing non-Hodgkin lymphoma.

How long will I be followed in the study?

Participants will be followed for a long time, up to 15 years, to understand the long-term effects and safety of the treatment.

Will I receive other medications?

Yes, you might receive other medications like chemotherapy, steroids, or pain relief as part of the study or to help manage side effects.

What if the treatment doesn't work for me?

The study aims to understand how well the treatment works for different people, and you will be closely monitored. Your doctors will discuss next steps based on your health and response.