Under construction – not a live service
Sign in
Taking peoplePhase 1

Pivekimab Sunirine for Children and Teens With Acute Myeloid Leukemia That Returned

Tests pivekimab sunirine for safety in children with returned or resistant leukemia.

Key facts

Who runs it
AbbVie Deutschland GmbH & Co. KG
Where
Gent, BelgiumSee the siteAlso in 5 other countries, 8 sites
Registry title
A Study to Assess Adverse Events and How Pivekimab Sunirine Moves Through the Body of Pediatric Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML)
Status
Recruiting
Phase
Phase 1
People taking part
18 people, planned
Started
8 Jul 2026
Expected to end
21 Mar 2030
Type of study
Interventional
Record updated
22 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and teenagers with acute myeloid leukemia (AML) that came back or did not respond to treatment, and whose leukemia cells carry the CD123 marker.

Age
Up to 17 years old.
Sex
All sexes can join.
Disease stage
AML confirmed under the microscope: second or later relapse, or no response to second or later treatment. At least 5% leukemia cells in the bone marrow. Leukemia in the central nervous system (CNS1, CNS2 or CNS3) is allowed if there are no signs or symptoms of it.
Earlier treatment
Must have had at least two earlier lines of treatment. Cannot have had CAR-T therapy before.
Biomarker or test result
Leukemia cells must be CD123-positive on flow cytometry (a lab test of blood or bone marrow cells).

Main reasons for not taking part

  • Down syndrome
  • Known significant heart disease
  • Acute promyelocytic leukemia (APL) or juvenile myelomonocytic leukemia (JMML)
  • Leukemia in the central nervous system with symptoms (CNS3)
  • Past liver VOD/SOS (veno-occlusive disease) of any severity

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • Participants must have histologically confirmed AML meeting one of the following disease criteria:• Second or greater relapse OR • Disease refractory to second or subsequent line of therapy (defined as resistant disease after at least one cycle of each treatment regimen)
  • Participants must have myeloid leukemic blasts that are CD123-positive by flow cytometry as determined by the treating institution
  • Participant has ≥5% myeloid leukemic blasts in bone marrow at time of relapse or refractory disease and prior to Screening for this study
  • Performance status by Lansky (< 16 years old at evaluation) or Karnofsky (≥ 16 years old at evaluation) score ≥ 50 or ECOG score ≤ 2
  • Participants may have status of CNS1, CNS2, or CNS3 disease without clinical signs or neurologic symptoms suggestive of CNS leukemia, such as facial nerve palsy, brain/eye involvement or hypothalamic syndrome. Participants may have non-CNS extramedullary disease

Who cannot take part

  • Participant has prior history of any severity VOD/SOS (veno-occlusive disease/sinusoidal obstructive syndrome) of the liver
  • Participants who have received prior CAR-T therapy
  • Participant has known clinically significant cardiac disease
  • Participant with Down syndrome
  • Participant has symptomatic central nervous system (CNS3) disease
  • Participant has acute promyelocytic leukemia (APL) or juvenile myelomonocytic leukemia (JMML)

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • How old are you?
  • Has your leukemia (AML) been treated yet? Please do not count hydroxyurea (a tablet that lowers white blood cell counts) or leukapheresis (a machine that filters extra white blood cells out of your blood).
  • Do you have serious heart disease, such as a recent heart attack or heart failure?
  • How old is the patient who may join a trial?
  • What type of cancer has the patient been diagnosed with?
  • Is this cancer newly diagnosed, or has it come back or not responded to treatment?
  • Has the patient had Down syndrome (an extra copy of chromosome 21) diagnosed?

Where in Belgium

Also in 5 other countries, 8 sites

  • Universitair Ziekenhuis GentGent, BelgiumNot yet recruiting

About the trial

What the trial wants to find out

To determine the safety and pharmacokinetic profile of PVEK in pediatric subjects with relapsed/refractory CD-123-positive AML

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
A Phase 1b Study of the Safety and Pharmacokinetics of Pivekimab Sunirine in Pediatric Subjects with Relapsed or Refractory Acute Myeloid Leukemia (AML).
Plain-language title
Pivekimab Sunirine for Children and Teens With Acute Myeloid Leukemia That ReturnedGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Fit questions
Built from 2024-520125-36-00, who can take part
Record updated
22 July 2026