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NCT07306832PHASE1Recruiting

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)

AbbVie

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

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Interventions

DRUG

Pivekimab Sunirine

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Conditions

Acute Myeloid Leukemia

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