AuthorisedTherapeutic confirmatory (Phase III)Interventional

International Study for Treatment of Childhood Relapsed Precursor B-Cell ALL 2020 - A Randomized Phase III Study Conducted by the Resistant Disease Committee of the International BFM Study Group - IntReALL BCP 2020

This study, called IntReALL BCP 2020, is for children aged 18 and under who have a type of blood cancer called B-cell acute lymphoblastic leukaemia (ALL) that has returned after previous treatment. The main goal is to find better ways to treat this relapsed cancer by testing different combinations of medicines. Researchers hope to learn which treatments help children live longer without their cancer coming back, reduce side effects, and improve their chances of getting well. It's a large study, meaning many children will take part, which helps doctors understand which treatments work best for different situations.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Charite Universitaetsmedizin Berlin KöR

Enrolment target

765

Start

09 Dec 2025

Relapsed Acute Lymphoblastic Leukemia (ALL)

What is this study about?

This important study, called IntReALL BCP 2020, focuses on children who have been diagnosed with a type of blood cancer called B-cell acute lymphoblastic leukaemia (ALL). This particular study is for children whose cancer has unfortunately come back (relapsed) after they've already had treatment. When cancer comes back, doctors often need to try different approaches to treatment, and this study aims to find the best and safest ways to do that for children.

The main purpose of this study is to compare different combinations of medicines to see which ones are most effective at treating the cancer and stopping it from returning. They will also be looking closely at any side effects the treatments might cause. By gathering information from many children, the doctors hope to improve the chances of recovery and overall health for young patients with relapsed ALL. This kind of research is vital for developing better treatments for childhood cancers.

Ultimately, this study aims to help doctors make more informed decisions about treating children with relapsed B-cell ALL. It's about finding the most effective ways to treat the cancer, improve how long children live without their cancer returning, and lessen the impact of treatment on their bodies. This is a "Phase III" study, which means it's one of the final steps in testing new treatments before they can become standard care.

Key takeaways

New study for children (18 and under) with B-cell ALL that has come back.
Compares different drug combinations to find the best treatments.
Aims to improve survival and reduce cancer recurrence.
Closely monitors for side effects to ensure safety.
Participation involves specific treatments, regular check-ups, and monitoring.

Who may be eligible?

To be part of this study, a child must be 18 years old or younger. There are no restrictions based on whether the child is a boy or a girl; all sexes can participate.

Beyond age and sex, there will be other important medical criteria that a child needs to meet. These usually include details about their general health, the specific type of leukaemia they have, how well their organs are working, and how they responded to their previous treatments. These details help make sure that the child can safely take part in the study and that the results of the study are clear and reliable.

The medical team will carefully review all of a child's medical information to see if they are a good fit for this study. It's important to remember that meeting the basic age and sex requirements is just the first step.

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.

Is your child 18 years old or younger?
Has your child been diagnosed with B-cell acute lymphoblastic leukaemia (B-ALL)?
Has your child's B-ALL returned after previous treatment?
Is your child generally well enough to tolerate intensive treatment?
Are you able to commit to regular hospital visits and follow-ups?

Answer every question to see your result.

What does participation involve?

If your child takes part in this study, they will receive specific medications and treatments, which might include various chemotherapy drugs, new antibody therapies, or combinations of both. The exact treatment they receive will depend on their specific situation and the part of the study they are in. They will have regular check-ups, blood tests, and other assessments to monitor their health and how the treatment is working. This also involves watching for any side effects.

The study involves different stages of treatment, such as a first stage to get the cancer under control (called 'induction'), followed by further stages to keep the cancer away (called 'consolidation'). At each stage, doctors will look at how well the treatment is working. The total duration of participation in the study, including treatment and follow-up, can vary but will be clearly explained by the study team. Some parts of the study might involve hospital stays, while others could involve outpatient visits.

Potential risks and benefits

Taking part in this study could offer some children access to potentially more effective or newer treatments for their relapsed leukaemia, which might improve their chances of recovery or help their cancer stay away longer. However, like all medical treatments, there are potential risks involved. The medicines used can have side effects, which range from mild to severe, and could include feeling unwell, infections, or other complications. The study team will monitor your child closely for these. You always have the right to withdraw your child from the study at any time, for any reason, without it affecting their ongoing medical care.

Locations (11)

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

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Unverified
Netherlands
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Unverified
Czechia
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Unverified
Italy
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Unverified
Spain
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Unverified
Denmark
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Unverified
Austria
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Unverified
Norway
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Unverified
Sweden
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Unverified
Germany
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Unverified
France
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Unverified
Finland

Common questions

What kind of cancer is this study for?

This study is for children with 'B-cell acute lymphoblastic leukaemia' (B-ALL) that has returned after previous treatment.

Will my child definitely get a new type of drug?

The study compares different treatment approaches, which might include combinations of existing drugs and newer therapies. Your child's doctor will explain the specific treatment options.

How long does the study last?

The total time your child is involved, including treatment and follow-up, can vary. The study team will give you a clear timeline.

What if my child experiences side effects?

The medical team will closely monitor your child for any side effects and will provide care to manage them.

Can we stop participating if we change our mind?

Yes, you have the right to withdraw your child from the study at any time, and their medical care will continue as usual.