Pivekimab sunirine for children with acute myeloid leukemia that returned or did not respond
Tests pivekimab sunirine for safety in children with relapsed or refractory acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: 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)
Key facts
- Where
- Perth and Westmead, AustraliaSee the 2 sites
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children and teenagers with acute myeloid leukemia (AML) that has come back or has not responded to at least two lines of treatment. All receive IV pivekimab sunirine.
- Age
- From 6 Months to 17 Years.
- Sex
- All sexes can join.
- Disease stage
- AML confirmed by tissue tests, in a second or later relapse, or not responding to a second or later line of treatment. At least 5% leukemic blasts in the bone marrow.
- Earlier treatment
- Must have relapsed twice or more, or not responded to a second or later line of treatment. Cannot have had CAR-T therapy before. A stem cell transplant within the last 6 months is not allowed, unless there is no active graft-versus-host disease (GvHD) and no anti-GvHD or anti-rejection medicines are needed (except a stable dose of corticosteroids).
- Biomarker or test result
- Leukemic blasts must be CD123-positive by flow cytometry.
Main reasons for not taking part
- Down syndrome
- Acute promyelocytic leukemia (APL) or juvenile myelomonocytic leukemia (JMML)
- Symptomatic central nervous system (CNS3) disease
- Known clinically significant heart disease
- Past veno-occlusive disease/sinusoidal obstructive syndrome (VOD/SOS) of the liver of any severity
Read by machine on 9 November 2026.
Where in Australia
- Perth Children'S Hospital /ID# 275673Perth, AustraliaTaking people
- The Children's Hospital at Westmead /ID# 275672Westmead, AustraliaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AbbVie
- Trial code
- NCT07306832
- Record updated
- 5 October 2026
- Original description
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.Read full original descriptionShow less
A Phase 1b Study of the Safety and Pharmacokinetics of Pivekimab Sunirine in Pediatric Subjects With Relapsed or Refractory Acute Myeloid Leukemia (AML)
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.
Inclusion: 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: 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; 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; Known clinically significant cardiac disease; Down syndrome; Symptomatic central nervous system (CNS3) disease; Any other known current malignancy requiring therapy; Acute promyelocytic leukemia (APL) or juvenile myelomonocytic leukemia (JMML).