Pivekimab Sunirine in Children with Relapsed or Refractory AML

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, single-arm phase 1 trial enrolling about 18 pediatric participants with relapsed or refractory AML at up to 30 sites worldwide. Participants will receive IV pivekimab sunirine dosed by weight in one of three age-based cohorts. The study focuses on pharmacokinetics, adverse events, and tolerability over a total duration of about 28 months. Regular hospital visits will be required to monitor health status and treatment effects. Enrollment criteria require confirmed AML with CD123-positive blasts and adequate performance status, with some CNS disease allowed if without active neurologic symptoms.

Why it matters

Who can join: the full rules

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.

Where it's running

• Lucile Packard Children's Hospital /ID# 276015
  Palo Alto, California, United States Recruiting
• Children'S Healthcare Of Atlanta - Arthur M. Blank Hospital /ID# 275740
  Atlanta, Georgia, United States Recruiting
• New York Medical College /ID# 275597
  Valhalla, New York, United States Recruiting
• Tristar Centennial Medical Center /ID# 275831
  Nashville, Tennessee, United States Recruiting
• Children's Medical Center Dallas /ID# 275930
  Dallas, Texas, United States Recruiting
• The Children's Hospital at Westmead /ID# 275672
  Westmead, New South Wales, Australia Recruiting

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.