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)

Study Identifier
M25-692
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
2024-520125-36
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Study Details

Medical Condition
  • Blood Cancer - Acute Myeloid Leukemia (AML)
  • Study Drug
  • Pivekimab Sunirine
  • Phase
    Phase 1
    Sex
    Female & Male
    Age
    6 Months - 17 Years

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Lucile Packard Children's Hospital /ID# 276015
    Palo Alto, California, United States, 94304
    Status
    Recruiting
    Location
    New York Medical College /ID# 275597
    Valhalla, New York, United States, 10595
    Status
    Recruiting
    Location
    Tristar Centennial Medical Center /ID# 275831
    Nashville, Tennessee, United States, 37203
    Status
    Recruiting
    Location
    Perth Children'S Hospital /ID# 275673
    Perth, Western Australia, Australia, 6009
    Status
    Recruiting
    Location
    National Taiwan University Hospital /ID# 276635
    Taipei, Taiwan, 100
    Status
    Recruiting