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)

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 participan

Trial Details

NCT ID
NCT07306832
Phase
PHASE1
Sponsor
AbbVie
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Pivekimab Sunirine
Locations (sample)
  • Palo Alto, California, United States|37.44188,-122.14302
  • Atlanta, Georgia, United States|33.749,-84.38798
  • Valhalla, New York, United States|41.07482,-73.77513
  • Nashville, Tennessee, United States|36.16589,-86.78444
  • Dallas, Texas, United States|32.78306,-96.80667

Key Eligibility 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.

For full eligibility, visit ClinicalTrials.gov.

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