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)

Active:	Yes
Cancer Type:	Hematopoietic Malignancies Leukemia Unknown Primary	NCT ID:	NCT07306832
Trial Phases:	Phase I	Protocol IDs:	M25-692 (primary) NCI-2026-04003 2024-520125-36
Eligibility:	6 Months - 17 Years, Male and Female	Study Type:	Treatment
Study Sponsor:	Abbvie
NCI Full Details:	http://clinicaltrials.gov/show/NCT07306832

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.

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.