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A study to evaluate the safety and how pivekimab sunirine works in children with relapsed or refractory acute myeloid leukemia

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on children and young people living with Acute Myeloid Leukemia, which is a type of cancer that affects the blood and bone marrow. The research is specifically for those whose cancer has either returned after previous treatment, known as Relapsed, or has not responded to initial therapies, known as Refractory. The investigation aims to evaluate the safety and how the body processes a new medication called pivekimab sunirine.

The treatment being tested is administered as a powder for infusion, which is delivered directly into a vein through intravenous use. During the study, participants will receive this medication to help researchers understand how it moves through the body and to monitor any potential side effects. This process allows for a closer look at how the drug behaves in patients with this specific form of cancer.

The research process

The trial runs in 1 step.

Step 1
Administration of study medication
The medication pivekimab sunirine is administered through an intravenous infusion, which means it is delivered directly into a vein using a needle or a small tube.
The medication is provided in a powder for infusion form.

Who can join the trial?

7 criteria

The patient must have Acute Myeloid Leukemia, which is a type of cancer that affects the blood and bone marrow.
The cancer must have either returned after a previous treatment (known as relapsed) or must not have responded to the treatments already given (known as refractory).
The cancer cells must test positive for a specific marker called CD123 using a laboratory test called flow cytometry, which is a method used to identify and count specific types of cells.
There must be at least 5% of leukemic blasts, which are immature cancer cells, found in the bone marrow (the soft tissue inside bones where blood cells are made) at the time of testing.
The patient must be able to perform daily activities to a certain level, measured by specific scales like Lansky, Karnofsky, or ECOG scores, which help doctors understand a patient's ability to function.
The cancer may have spread to the central nervous system (the brain and spinal cord), but the patient must not show any physical signs or symptoms of this, such as problems with facial nerves or vision.
The patient may have extramedullary disease, which means the cancer has spread to parts of the body outside of the bone marrow.

Who cannot join the trial?

6 criteria

You have a known clinically significant cardiac disease, which means a heart condition that is serious enough to affect your health or medical treatment.
You have Down syndrome, which is a genetic condition caused by an extra chromosome.
You have acute promyelocytic leukemia (APL) or juvenile myelomonocytic leukemia (JMML), which are specific and different types of blood cancers.
You have symptomatic central nervous system (CNS3) disease, which means there are noticeable symptoms or problems affecting the brain or spinal cord.
You have a history of veno-occlusive disease (VOD) or sinusoidal obstructive syndrome (SOS), which are conditions where the small blood vessels in the liver become blocked.
You have previously received CAR-T therapy, which is a specific type of immune system treatment used to fight cancer.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Assistance Publique Hopitaux De Paris
Verified
Paris, France
Semmelweis University
Responsive
Budapest, Hungary
Universitair Ziekenhuis Gent
Responsive
Gent, Belgium

Trial locations

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Investigated drugs

Pivekimab sunirine is an experimental treatment given through an IV infusion to help treat children with a specific type of blood cancer called acute myeloid leukemia that has returned or did not respond to previous treatments.

Pivekimab Sunirine

What is already known about the treatment

Pivekimab sunirine - This medication is provided as a powder that is mixed into a liquid and given directly into a vein through an infusion. It is currently being studied in clinical trials to see how safe and effective it is for treating certain types of blood cancer in children. The drug works by targeting a specific protein called CD-123 found on the surface of leukemia cells, allowing it to attach to and help destroy these harmful cells. It is classified as a targeted antibody therapy designed to treat relapsed or resistant acute myeloid leukemia.

Investigated diseases

Acute Myeloid Leukemia
This is a type of cancer that affects the blood and bone marrow. It occurs when the body produces too many immature white blood cells, known as myeloblasts. These abnormal cells build up in the bone marrow and prevent the production of healthy blood cells. The disease typically progresses rapidly as the abnormal cells multiply and crowd out normal cells. Over time, this leads to a shortage of red blood cells, healthy white blood cells, and platelets.
Relapsed or Refractory Acute Myeloid Leukemia
This condition refers to Acute Myeloid Leukemia that either returns after a period of improvement or does not respond to initial therapy. In relapsed cases, the cancer cells begin to multiply again after a period where they were not detectable. In refractory cases, the cancer cells continue to grow despite undergoing treatment. The progression involves the continued accumulation of abnormal myeloid cells in the bone marrow and bloodstream.