RecruitingPhase 1NCT07306832

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)

A Phase 1b Study of the Safety and Pharmacokinetics of Pivekimab Sunirine in Pediatric Subjects With Relapsed or Refractory Acute Myeloid Leukemia (AML)


Sponsor

AbbVie

Enrollment

18 participants

Start Date

May 20, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 6 MonthsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Pivekimab Sunirine for people with acute myeloid leukemia. The study is currently recruiting participants at 7 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPivekimab Sunirine

Intravenous


Locations(9)

Lucile Packard Children's Hospital /ID# 276015

Palo Alto, California, United States

New York Medical College /ID# 275597

Valhalla, New York, United States

Tristar Centennial Medical Center /ID# 275831

Nashville, Tennessee, United States

Perth Children'S Hospital /ID# 275673

Perth, Western Australia, Australia

Hopital Armand Trousseau /ID# 276231

Paris, France

Ospedale Pediatrico Bambino Gesu /ID# 275692

Rome, Roma, Italy

Seoul National University Hospital /ID# 276978

Seoul, Seoul Teugbyeolsi, South Korea

Samsung Medical Center /ID# 276979

Seoul, Seoul Teugbyeolsi, South Korea

National Taiwan University Hospital /ID# 276635

Taipei, Taiwan

View Full Details on ClinicalTrials.gov

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NCT07306832


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