AuthorisedTherapeutic confirmatory (Phase III)Interventional

The INFLUENCE Trial: Improving EveNt Free Survival by Optimizing FLUdarabine Exposure during LymphodepletioN for CAR T CEll Therapy: a randomized, multi-center study of children and young adults with B-cell acute lymphoblastic leukemia

This important study, called the INFLUENCE Trial, is for children and young adults in the UK who have a type of blood cancer called B-cell Acute Lymphoblastic Leukemia. It's a Phase III trial, meaning it's in a late stage of testing a new approach. The main goal is to find the best way to give a medicine called fludarabine during CAR T-cell therapy. Researchers want to see if fine-tuning the dose of fludarabine can help patients stay free from cancer for longer. This involves carefully looking at how well the CAR T-cells work, if the cancer comes back, and how patients feel overall. It aims to improve treatment for this serious condition.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Prinses Maxima Centrum voor Kinderoncologie B.V.

Enrolment target

Start

16 Apr 2026

B-cell Acute Lymphoblastic Leukemia

What is this study about?

This study, called the INFLUENCE Trial, is looking into how well a medicine called fludarabine works when given alongside a special type of treatment called CAR T-cell therapy. This therapy is used for children and young adults who have a specific type of blood cancer called B-cell Acute Lymphoblastic Leukemia.

Fludarabine is given before CAR T-cell therapy to help prepare the body for the new CAR T-cells. The researchers want to find out if there's an ideal amount of fludarabine to give that will help the CAR T-cells work even better, leading to a longer period of good health for patients. They are comparing different ways of giving fludarabine to see which method is most effective at keeping the cancer away.

Finding the best way to use fludarabine could make CAR T-cell therapy more successful for more patients. Your involvement would help doctors understand how to give children and young adults with this type of leukaemia the best possible chance of staying well.

Key takeaways

This study is for children and young adults with B-cell Acute Lymphoblastic Leukemia.
It aims to find the best way to use fludarabine with CAR T-cell therapy.
The goal is to help patients stay cancer-free for longer.
Participation involves monitoring how your body responds to the treatment.
It's a Phase III study, meaning it's a key step in improving treatment.
Only individuals aged 18 and over are considered for this particular study.

Who may be eligible?

This study is designed for young people, specifically those aged 18 and older. However, the full eligibility criteria are not provided here, so it's important to discuss this with your doctor.

Both males and females can take part in this research.

Crucially, only individuals who have been diagnosed with B-cell Acute Lymphoblastic Leukemia would be considered. Your medical team will be able to tell you if your specific health situation matches what the researchers are looking for.

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?
Have you been diagnosed with B-cell Acute Lymphoblastic Leukemia?
Are you potentially able to receive CAR T-cell therapy?
Are you willing to have regular medical check-ups and blood tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the fludarabine medication as part of your CAR T-cell therapy. The main difference would be that the amount of fludarabine you receive might be adjusted based on the study's design. This would involve regular checks of the medicine levels in your system.

You would have scheduled hospital visits for your treatment and follow-up. During these visits, doctors would monitor your health carefully, including blood tests and other assessments, to see how the treatment is working and if there are any side effects. These checks would continue for a period after your CAR T-cell infusion, with doctors looking at things like how long specific immune cells (B-cells) are low, whether the cancer comes back, and your overall health. The total time you'd be part of the study would be several years, with close monitoring especially during the first year or two after your CAR T-cell therapy.

Potential risks and benefits

Taking part in this study means you might receive a carefully adjusted dose of an existing medicine, fludarabine, which could potentially improve the effectiveness of your CAR T-cell therapy, helping you stay healthy for longer. However, like all medical treatments, there are potential risks, including side effects from the medications or CAR T-cell therapy itself. These will be fully explained by your medical team. You also have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (3)

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

—
Unverified
Spain
—
Unverified
Germany
—
Unverified
Netherlands

Common questions

What is B-cell Acute Lymphoblastic Leukemia?

It's a fast-growing type of cancer that affects the white blood cells called lymphocytes in the bone marrow and blood.

What is CAR T-cell therapy?

It's a special treatment where a patient's own immune cells (T-cells) are collected, modified in a lab to fight cancer, and then put back into the patient's body.

What is fludarabine?

Fludarabine is a chemotherapy medicine often given before CAR T-cell therapy to help prepare the body and make the CAR T-cells work better.

What does 'Phase III' mean for this study?

Phase III means this study is in a late stage of testing. It's comparing a new method of giving fludarabine to see if it's better than current approaches for a large group of patients.

What does a 'response' mean in this study?

A good response means the cancer is under control, the CAR T-cells are working well, and there are no signs of the cancer returning.