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)
Start Date
5/20/2026
Completion Date
3/1/2030
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.
Eligibility Criteria
Age Range: No minimum to 17 years
Interventions
Pivekimab Sunirine
Conditions
Locations
Lucile Packard Children's Hospital /ID# 276015
Palo Alto, California 94304
United States
New York Medical College /ID# 275597
Valhalla, New York 10595
United States
Tristar Centennial Medical Center /ID# 275831
Nashville, Tennessee 37203
United States
Perth Children'S Hospital /ID# 275673
Perth, Western Australia 6009
Australia
Ospedale Pediatrico Bambino Gesu /ID# 275692
Rome, Roma 00165
Italy
Seoul National University Hospital /ID# 276978
Seoul, Seoul Teugbyeolsi 03080
South Korea
Samsung Medical Center /ID# 276979
Seoul, Seoul Teugbyeolsi 06351
South Korea
National Taiwan University Hospital /ID# 276635
Taipei, 100
Taiwan