AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

A Phase 1b Study of the Safety and Pharmacokinetics of Pivekimab Sunirine in Pediatric Subjects with Relapsed or Refractory Acute Myeloid Leukemia (AML).

This study is a Phase 1b clinical trial, which means it's an early-stage study looking at a new medicine called Pivekimab Sunirine. It's for children and teenagers who have Acute Myeloid Leukaemia (AML), a type of blood cancer, that has either returned after treatment or hasn't improved with other medicines. The main goals are to understand how safe the new medicine is and how it behaves in the body (known as 'pharmacokinetics'). Researchers will carefully watch for any side effects and how these might lead to someone stopping treatment. They will also measure how much of the medicine stays in the body and for how long. The study also aims to see if the medicine can help patients achieve remission, which means the cancer signs are gone or greatly reduced.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Other

Sponsor

AbbVie Deutschland GmbH & Co. KG

Enrolment target

Start

20 Apr 2026

Relapsed or Refractory Acute Myeloid Leukemia Acute Myeloid Leukemia, Acute Myeloid Leukemia

What is this study about?

This study is looking into a new medicine called Pivekimab Sunirine for children and teenagers who have Acute Myeloid Leukaemia (AML). AML is a cancer of the blood and bone marrow. Sometimes, despite treatment, the cancer can come back (this is called 'relapsed') or it might not get better at all (this is called 'refractory'). For these young patients, finding new treatment options is really important.

Because this is an early-stage study (Phase 1b), the main focus is on safety. The medical team will be very carefully watching for any side effects that people might experience while taking Pivekimab Sunirine. They also want to understand how the medicine travels through the body, how much of it is absorbed, and how long it stays there. This information helps doctors work out the best doses for future studies.

While safety is the priority, the doctors will also be looking to see if the medicine helps improve the patient's condition. They will check to see if the cancer goes away completely (this is called 'complete remission') or if it gets much better. Understanding both the safety and any potential benefits of Pivekimab Sunirine is key to developing new treatments for AML.

Key takeaways

This study is for children and teenagers with a type of blood cancer called AML.
It's an early study looking at a new medicine called Pivekimab Sunirine.
The main goals are to check the medicine's safety and how it works in the body.
It also looks to see if the medicine helps improve the cancer.
You can withdraw from the study at any time.

Who may be eligible?

This study is open to children and teenagers of all ages who have Acute Myeloid Leukaemia (AML).

You can take part if your AML has come back after previous treatments (this is called 'relapsed AML') or if it hasn't responded to other treatments given before (this is called 'refractory AML'). Both boys and girls can join the study. The medical team will carefully review each potential participant's health records to make sure the study is a safe and suitable option for them.

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.

Do you have Acute Myeloid Leukaemia (AML)?
Has your AML come back after treatment, or not improved with other medicines?
Are you a child or teenager?
Are you able to attend regular hospital or clinic visits?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the new medicine called Pivekimab Sunirine. You will have regular visits to the hospital or clinic so the medical team can monitor your health closely. During these visits, they will carry out examinations, take blood and other samples, and ask you how you are feeling. This is to check for any side effects and to see how the medicine is working in your body. There will also be follow-up appointments after you finish taking the medicine to ensure your well-being. The exact number of visits and the total length of time you'll be involved in the study will be explained in detail by the study team.

Potential risks and benefits

Taking part in this study means you could potentially benefit from a new treatment for your AML, especially if other treatments haven't worked or the cancer has returned. However, as with any new medicine, there are potential risks, and you might experience side effects. The medical team will explain all the known risks and closely monitor you throughout the study. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (6)

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

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Unverified
Spain
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Unverified
Hungary
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Unverified
Czechia
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Unverified
France
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Unverified
Italy
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Unverified
Belgium

Common questions

What is Acute Myeloid Leukaemia (AML)?

AML is a type of cancer that affects the blood and bone marrow, which is where new blood cells are made.

What does 'relapsed or refractory' mean?

'Relapsed' means the cancer has come back after treatment. 'Refractory' means the cancer has not responded to previous treatments.

What is a Phase 1b study?

This is an early study to check if a new medicine is safe and to understand how it works in the body. It’s not mainly about whether it cures the disease, but rather how well it's tolerated.

Will I know if the medicine is working?

The medical team will regularly check your health and will be able to tell you if they see signs that the medicine is having an effect on your AML.

Can I stop being part of the study?

Yes, you can decide to leave the study at any time, and you don't need a reason. It won't affect your future medical care.