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)
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Potwierdzona diagnoza białaczki ostrej szpikowej z drugim lub kolejnym nawrotem choroby lub brakiem odpowiedzi na leczenie
- •Komórki białaczki muszą posiadać marker CD123 potwierdzona badaniem laboratoryjnym
- •Co najmniej 5% komórek białaczki w szpiku kostnym
- •Ogólny stan zdrowia na poziomie umożliwiającym uczestnictwo w badaniu
- •Może występować białaczka ze zajęciem ośrodkowego układu nerwowego bez objawów neurologicznych
- •Dla dzieci: zgoda rodziców lub opiekunów prawnych i chęć dziecka do udziału w badaniu
✗ Disqualifies
- •Poważne choroby serca
- •Zespół Downa
- •Ostra białaczka promielociarna lub młodzieńcza białaczka mielomonocytowa
- •Objawy białaczki ze zajęciem ośrodkowego układu nerwowego
- •Historia zespołu niedrożności naczyń wątroby
- •Przeszczep szpiku kostnego wykonany w ciągu 6 miesięcy przed badaniem bez poważnych powikłań
Simplified criteria — AI translation
Trial details
- Minimum age
- 6 Months
- Maximum age
- 17 Years
- Last updated (source)
- July 13, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (8)
Lucile Packard Children's Hospital /ID# 276015
Palo Alto, United States
New York Medical College /ID# 275597
Valhalla, United States
Tristar Centennial Medical Center /ID# 275831
Nashville, United States
Perth Children'S Hospital /ID# 275673
Perth, Australia
Ospedale Pediatrico Bambino Gesù /ID# 275692
Rome, Italy
Seoul National University Hospital /ID# 276978
Seoul, South Korea
Samsung Medical Center /ID# 276979
Seoul, South Korea
National Taiwan University Hospital /ID# 276635
Taipei, Taiwan
Trial contact
ABBVIE CALL CENTER
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/14/2026.
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