AuthorisedTherapeutic use (Phase IV)Interventional

A Randomized Trial of the I-BFM-SG for the Management of Childhood non-mature-B Acute Lymphoblastic Leukemia

This study is for children with a specific type of leukaemia called non-mature B-cell acute lymphoblastic leukaemia. It's looking at whether combining a drug called Riximyo with standard chemotherapy helps children stay healthy for longer. Researchers will be checking how long it takes for the leukaemia to come back, or if other health issues arise, after treatment. They'll also be carefully monitoring for any side effects from the treatments, such as infections or reactions to Riximyo. This is a "Phase IV" study, meaning the treatments are already approved but researchers are gathering more information about their use in combination and long-term effects.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Semmelweis University

Enrolment target

775

Start

08 Dec 2024

Childhood non-mature-B Acute Lymphoblastic Leukemia

What is this study about?

This study is all about finding better ways to treat a type of childhood blood cancer called non-mature B-cell acute lymphoblastic leukaemia. This can be a challenging condition, and doctors are always looking for treatments that are both effective and safe for children. The study is particularly interested in a drug called Riximyo, and whether adding it to the usual chemotherapy treatments makes a positive difference.

The main goal of the study is to see if children who receive Riximyo with their chemotherapy live longer without the leukaemia returning or other serious health problems developing. This is a very important measure, as it tells us how well the treatment works in the long run. Researchers will also be checking for any side effects or complications that might occur, such as infections or reactions to the drugs, as patient safety is always a top priority.

This is called a "Phase IV" study. This means that the drugs being used (Riximyo and Oncaspar) are already approved by health authorities for use in patients. However, doctors are still learning more about how they work together, and how they affect children over time. By taking part, families are helping doctors understand the best ways to use these medicines to help children with leukaemia.

Key takeaways

This study is testing a new combination of medicines for a type of childhood leukaemia.
It aims to see if adding Riximyo improves how long children stay well.
Safety, including side effects like infections, will be carefully monitored.
The drugs used are already approved, but their combined effect is being studied.
Participation involves ongoing medical check-ups and monitoring.
Families can choose to withdraw from the study at any time.

Who may be eligible?

This study is open to all children, regardless of their age or gender, who have been diagnosed with non-mature B-cell acute lymphoblastic leukaemia. The medical team will carefully review each child's health information to make sure the study is a good fit for them.

There might be other specific health conditions or treatments that mean a child can't take part, to ensure their safety. The doctors and nurses managing the study will discuss all these details with families to help them understand if their child can participate.

Quick self-check

My child has been diagnosed with non-mature-B acute lymphoblastic leukaemia.
My child's doctors think this study might be suitable for them.
My child is able to receive the required study medications.
My family understands the commitment to regular hospital visits and tests.

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If a child joins this study, they will receive either the standard chemotherapy treatment or the standard chemotherapy combined with Riximyo. The specific treatments will follow a set plan over several months.

Children will have regular check-ups, blood tests, and other medical assessments throughout their treatment. These are important for monitoring their health, checking how the leukaemia is responding, and watching for any side effects. These visits will be part of their overall cancer care. The study will continue to follow children for an extended period after their main treatment finishes to see how they are doing in the long term, making sure to track their health and any potential late effects.

Potential risks and benefits

Participating in this study might offer the potential benefit of a new treatment approach that could be more effective than standard care, though this is not guaranteed. However, like all medical treatments, there are potential risks. Adding new medications could lead to different or more severe side effects, such as a higher risk of infections or reactions to Riximyo. The medical team will closely monitor your child for these. You have the right to withdraw your child from the study at any time, for any reason, without affecting their future medical care.

Locations (4)

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Greece
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Hungary
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Croatia
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Slovenia

Common questions

What is non-mature B-cell acute lymphoblastic leukaemia?

It's a type of cancer that affects the white blood cells in children. It starts in the bone marrow, where blood cells are made.

What is Riximyo and Oncaspar?

These are medications used to treat cancer. Riximyo is designed to target specific cells, while Oncaspar is a type of chemotherapy.

What does 'primary endpoint' mean?

It's the main thing the researchers are looking to measure to see if the new treatment is helping, like how long children stay well after treatment.

Will my child definitely get the new drug?

The study involves randomisation, which means a computer decides whether your child receives the standard treatment or the new drug combination. You won't know which they are getting until after that decision is made.

Who is funding this study?

The study is sponsored by a group called the I-BFM-SG, which focuses on childhood leukaemia and lymphoma clinical trials.