AuthorisedPhase I and Phase II (Integrated)- OtherInterventional

A Phase 1b/2 Study to Investigate the Safety, Efficacy and Pharmacokinetics of Administration of Subcutaneous (SC) Blinatumomab in Pediatric Participants with Relapsed/Refractory (R/R) and Minimal Residual Disease Positive (MRD+) B Cell Precursor Acute Lymphoblastic Leukemia (B-ALL)

This research study is investigating a new way to give an existing medicine called blinatumomab to children and young people with acute lymphoblastic leukaemia (ALL) that has either returned (relapsed) or has not fully cleared up (minimal residual disease positive). Instead of giving it through a drip, this study is testing it as a simple injection under the skin. The main goals are to understand how safe this new way of giving the medicine is, how well it works to control the leukaemia, and how the body handles it. This study is being done in two parts, first looking closely at safety and then at its effectiveness for different groups of patients with ALL.

At a glance

Status

Authorised

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Amgen Inc.

Enrolment target

Start

13 Feb 2026

Relapsed/Refractory (R/R) and Minimal Residual Disease Positive (MRD+) B-Cell Precursor Acute Lymphoblastic Leukemia

What is this study about?

This study is looking into a medicine called blinatumomab, which is already used to treat a type of blood cancer called B-cell precursor acute lymphoblastic leukaemia (B-ALL). This cancer affects certain white blood cells in children and young people. Currently, blinatumomab is usually given through a drip into a vein, which means patients often need to stay in hospital or visit a clinic frequently for a long time.

The main idea of this study is to see if blinatumab can be given as a simple injection under the skin instead. This could be much easier for patients and their families, potentially allowing for treatment at home or fewer hospital visits. Researchers want to ensure this new way of giving the medicine is safe and works just as well as, or even better than, the current method.

There are two main groups of patients the study is focusing on: those whose leukaemia has come back after treatment (relapsed/refractory) and those who still have a very small amount of leukaemia cells left in their body after treatment, even if they appear healthy (minimal residual disease positive). For both groups, the study aims to understand how well the medicine reduces the leukaemia cells and if it helps patients stay healthy for longer.

Key takeaways

This study is testing a new way to give an existing leukaemia medicine, blinatumomab, as an injection.
It's for children and young people with B-cell acute lymphoblastic leukaemia that has returned or still has very low levels of cancer cells.
The main goals are to check how safe the injections are and how well they work.
Giving medicine by injection might be more convenient than through a drip.
Participation involves regular hospital visits for treatment and check-ups.

Who may be eligible?

To be part of this study, participants need to be children or young people diagnosed with B-cell precursor acute lymphoblastic leukaemia. This type of leukaemia affects certain white blood cells.

Specifically, the leukaemia must have either returned after previous treatment (this is called 'relapsed' or 'refractory' leukaemia) or there must still be a very small amount of leukaemia cells in the body, even if the person seems to be completely well (this is called 'minimal residual disease positive').

There will also be other specific medical requirements that your medical team will check, but the study is open to both boys and girls of all ages who meet these main cancer criteria.

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.

Have you been diagnosed with B-cell acute lymphoblastic leukaemia?
Has your leukaemia either returned or do you have minimal residual disease (tiny amounts of cancer cells remaining)?
Are you a child or young person?
Are you able to attend regular appointments for treatment and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will receive the study medicine, blinatumomab, as an injection under the skin. The study will involve regular visits to the hospital or clinic to check your health, measure the levels of the medicine in your blood, and see how well the treatment is working. This will include blood tests and possibly other examinations. For the first part of the study, the focus will be finding the safest dose. After that, more people will join to see how well it treats the leukaemia.

You will have check-ups to monitor any side effects from the medication and to see how your leukaemia is responding. The duration of your participation will depend on how you respond to the treatment and the study plan, but it will involve multiple treatment cycles and follow-up appointments.

Potential risks and benefits

Taking part in this study could offer potential benefits, such as access to a new way of receiving blinatumomab, which might be more convenient. The treatment aims to control or reduce leukaemia cells. However, all medical treatments carry risks. You might experience side effects from the blinatumomab, similar to those seen with the current way of giving it, or new side effects from the injection itself. The research team will explain all known risks. Your participation is completely 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 (3)

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

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Unverified
France
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Unverified
Netherlands
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Unverified
Italy

Common questions

What is blinatumomab?

It's a medicine used to treat a type of blood cancer called acute lymphoblastic leukaemia. It helps your immune system find and fight cancer cells.

What is the difference between 'relapsed' and 'MRD positive' leukaemia?

'Relapsed' means the leukaemia has returned after treatment. 'MRD positive' means there are still very tiny amounts of leukaemia cells in the body, which can be a sign it might come back.

Why is giving the medicine by injection being studied?

Giving medicine by injection under the skin might be easier and more convenient than getting it through a drip into a vein, potentially reducing hospital visits.

Will I get the new injection or the old drip method?

In this study, everyone will receive blinatumomab as an injection under the skin, as that is what the research is testing.

What does 'Phase 1b/2' mean?

Phase 1b means the study is mainly checking for safety and the right dose. Phase 2 means they are also looking at how well the treatment works for the cancer.