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)

Part of paid clinical trials in Palo Alto, California.

Sponsor
AbbVie
Study ID
NCT07306832
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
6 Months - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Pivekimab Sunirine — DRUG
    Intravenous

Study Details

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.

Key Dates

Start date
May 20, 2026
Status verified
May 2026
Primary completion
Apr 30, 2028
Completion
Mar 31, 2030

Study Design

Enrollment
18 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: Pivekimab Sunirine Ages 2 to < 6 Years
    Participants will receive pivekimab sunirine, as part of the approximately 28 month study duration. If enrolled, subjects aged 6 months to less than 2 years will be included in Cohort 1
  • Experimental: Cohort 2: Pivekimab Sunirine Ages 6 to < 12 Years
    Participants will receive pivekimab sunirine, as part of the approximately 28 month study duration.
  • Experimental: Cohort 3: Pivekimab Sunirine Ages 12 to < 17 Years
    Participants will receive pivekimab sunirine, as part of the approximately 28 month study duration.

Primary Outcome Measure

Number of Participants with Treatment-Emergent Adverse Events (TEAEs) Leading to Treatment Discontinuation [ Time Frame: Up to Approximately 24 Months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Lucile Packard Children's Hospital /ID# 276015Palo AltoCalifornia94304-
New York Medical College /ID# 275597ValhallaNew York10595-
Tristar Centennial Medical Center /ID# 275831NashvilleTennessee37203-

Find similar trials in Palo Alto, CA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Lucile Packard Children's Hospital· Palo Alto, CANew York Medical College· Valhalla, NYTristar Centennial Medical Center· Nashville, TN

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