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 now · Phase 1

Conditions studied: Acute Myeloid Leukemia

In brief

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.

Key facts

Study ID: NCT07306832
Run by: AbbVie
People needed: 18
Starts: 2026-05-20
Expected to finish: 2030-03-01
Last updated by the study team: 2026-08-06

Who can join

Age: 1 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Must have histologically confirmed acute myeloid leukemia (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).
Must have myeloid leukemic blasts that are CD123-positive by flow cytometry as determined by the treating institution.
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.
May have status of central nervous system (CNS)1, 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 receiving intrathecal therapy and no additional CNS-directed systemic therapy at study entry are eligible and may continue treatment as clinically indicated in accordance with institutional practice.
For those participants who have not reached the age of consent, parent or legal guardian with the willingness and ability to provide informed consent and participant willing and able to give assent, as appropriate for age and country.

You may not qualify if…

Known clinically significant cardiac disease.
Down syndrome.
Acute promyelocytic leukemia (APL) or juvenile myelomonocytic leukemia (JMML).
Symptomatic central nervous system (CNS3) disease
Prior history of any severity veno-occlusive disease/sinusoidal obstructive syndrome (VOD/SOS) of the liver.
Prior history of hematopoietic stem cell transplant within 6 months prior to Screening without evidence of active GvHD at the time of screening and the participant is off medications to treat or prevent either post-transplant graft-versus-host disease (GvHD) or post-transplant rejection (except for a stable dose of corticosteroids).
Have received prior Chimeric Antigen Receptor T-cell (CAR-T) therapy.
Any other known current malignancy requiring therapy.
Currently receiving anticancer therapy with antineoplastic intent, including radiotherapy, systemic therapy small molecules, monoclonal antibodies, other investigational agents, or high-dose chemotherapy with the exception of intrathecal therapy.

Where it is running

Lucile Packard Children's Hospital /ID# 276015 — Palo Alto, California, United States (enrolling)
New York Medical College /ID# 275597 — Valhalla, New York, United States (enrolling)
Tristar Centennial Medical Center /ID# 275831 — Nashville, Tennessee, United States (enrolling)
Perth Children'S Hospital /ID# 275673 — Perth, Western Australia, Australia (enrolling)
Chu Bordeaux - Hopital Pellegrin /ID# 277645 — Bordeaux, New Aquitaine, France (enrolling)
Hopital Armand Trousseau /ID# 276231 — Paris, France (enrolling)
Ospedale Pediatrico Bambino Gesu /ID# 275692 — Rome, Roma, Italy (enrolling)
Seoul National University Hospital /ID# 276978 — Seoul, Seoul Teugbyeolsi, South Korea (enrolling)
Samsung Medical Center /ID# 276979 — Seoul, Seoul Teugbyeolsi, South Korea (enrolling)
National Taiwan University Hospital /ID# 276635 — Taipei, Taiwan (enrolling)

Full record on ClinicalTrials.gov

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