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)

NCT ID: NCT07306832

Last Updated: 2025-12-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-14
• Study Completion Date: 2028-04-30

Brief 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.

Conditions

Acute Myeloid Leukemia

Keywords

Acute Myeloid Leukemia; Relapsed; Refractory; Pivekimab Sunirine; PVEK; Pediatric

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Pivekimab Sunirine

Intervention Type: DRUG

Intravenous

Cohort 2: Pivekimab Sunirine Ages 6 to < 12 Years

Participants will receive pivekimab sunirine, as part of the approximately 28 month study duration.

Group Type: EXPERIMENTAL

Pivekimab Sunirine

Intervention Type: DRUG

Intravenous

Cohort 3: Pivekimab Sunirine Ages 12 to < 17 Years

Participants will receive pivekimab sunirine, as part of the approximately 28 month study duration.

Group Type: EXPERIMENTAL

Pivekimab Sunirine

Intervention Type: DRUG

Intravenous

Interventions

Pivekimab Sunirine

Intravenous

Intervention Type: DRUG

Eligibility Criteria

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 may have non-CNS extramedullary disease.
• 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.
• 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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Central Contacts

ABBVIE CALL CENTER

Role: CONTACT

Phone: 844-663-3742

Email: abbvieclinicaltrials@abbvie.com

Related Links

https://www.abbvieclinicaltrials.com/study/?id=M25-692

Related Info

Other Identifiers

2024-520125-36

Identifier Type: OTHER

Identifier Source: secondary_id

M25-692

Identifier Type: -

Identifier Source: org_study_id