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)
Key facts
- Where
- Budapest, MagyarországSee the site
- Phase
- 1. fázis
Could this be for you?
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 Magyarország
- Semmelweis UniversityBudapest, MagyarországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AbbVie Deutschland GmbH & Co. KG
- Trial code
- EU 2024-520125-36-00
- Record updated
- 2026. július 22.
- Original description
To determine the safety and pharmacokinetic profile of PVEK in pediatric subjects with relapsed/refractory CD-123-positive AMLRead full original descriptionShow less
A Phase 1b Study of the Safety and Pharmacokinetics of Pivekimab Sunirine in Pediatric Subjects with Relapsed or Refractory Acute Myeloid Leukemia (AML).
To determine the safety and pharmacokinetic profile of PVEK in pediatric subjects with relapsed/refractory CD-123-positive AML
Inclusion: 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.
Exclusion: 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).