Clinical Trial

A Study to Assess Adverse Events and How Intravenous (IV) Pivekimab Sunirine Moves Through the Body in Pediatric Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML)

Recruiting Phase 1
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Summary
Acute myeloid leukemia (AML) is an aggressive blood cancer, withwith few options for participants who relapse after treatment or who don't respond to treatment. This study will assess the adverse events and how pivekimab sunirine moves through the body in pediatric participants with relapsed or refractory (R/R) AML. Pivekimab sunirine is a drug being evaluated in the treatment of AML. This is an open label, single arm study, participants will be enrolled in 1 of the 3 cohorts based on their age and will receive pivekimab sunirine at a dose based on their weight. Around 18 pediatric participants with a diagnosis of AML will be enrolled in the study at approximately 30 sites around the world. Participants will receive intravenous (IV) pivekimab sunirine alone. The total study duration is approximately 28 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, and checking for side effects.
Protocol Amendment History 3 changes
critical Recruitment opened 2026-06-03
notable Trial sites expanded: 0 -> 5 locations 2026-06-03
minor Completion pushed: 2028-04 -> 2030-03 2026-06-03
Trial Details
NCT Number NCT07306832
Lead Sponsor AbbVie
Conditions Acute Myeloid Leukemia
Enrollment 18 participants
Start Date 2026-05-20
Primary Completion 2028-04 (estimated)
Study Completion 2030-03 (estimated)
Updated on ClinicalTrials.gov 2026-08-14