A Study to Assess Adverse Events and How Pivekimab Sunirine Moves Through the Body of Pediatric Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AbbVie Deutschland GmbH & Co. KG

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2026-04-20

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

AbbVie

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic

To determine the safety and pharmacokinetic profile of PVEK in pediatric subjects with relapsed/refractory CD-123-positive AML

Secondary objectives 1

1. To estimate the anti-tumor activity of PVEK monotherapy in pediatric participants withrelapsed/refractory CD-123-positive AML.

Conditions and MedDRA coding

Relapsed or Refractory Acute Myeloid Leukemia; Acute Myeloid Leukemia

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration, National Agency For The Safety Of Medicine And Health Products

Plan to share IPD

Yes

IPD plan description

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information. To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/ For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Participants must have histologically confirmed 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)
2. Participants must have myeloid leukemic blasts that are CD123-positive by flow cytometry as determined by the treating institution.
3. Participant has ≥5% myeloid leukemic blasts in bone marrow at time of relapse or refractory disease and prior to Screening for this study.
4. Performance status by Lansky (< 16 years old at evaluation) or Karnofsky (≥ 16 years old at evaluation) score ≥ 50 or ECOG score ≤ 2.
5. Participants may have status of CNS1, 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.

Exclusion criteria 6

1. Participant has known clinically significant cardiac disease.
2. Participant with Down syndrome
3. Participant has acute promyelocytic leukemia (APL) or juvenile myelomonocytic leukemia (JMML)
4. Participant has symptomatic central nervous system (CNS3) disease
5. Participant has prior history of any severity VOD/SOS (veno-occlusive disease/sinusoidal obstructive syndrome) of the liver.
6. Participants who have received prior CAR-T therapy

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Treatment-emergent adverse events (TEAEs) leading to treatment discontinuation
2. PK parameters for intact ADC and payload (FGN849), including Cmax, AUC, and Tmax

Secondary endpoints 6

1. Complete Remission (CR)
2. Composite Complete Remission (CR + CRi)
3. Composite Complete Remission (CR + CRh)
4. Duration of Complete Remission (DOCR)
5. Duration of Composite Complete Remission (CR + CRi)
6. Duration of Composite Complete Remission (CR + CRh)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AbbVie Deutschland GmbH & Co. KG

Sponsor organisation

AbbVie Deutschland GmbH & Co. KG

Address

Knollstrasse

City

Ludwigshafen Am Rhein

Postcode

67061

Country

Germany

Scientific contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical TrialsHelpdesk

Public contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical TrialsHelpdesk

Third parties 5

Locations

6 EU/EEA countries · 9 investigational sites

By country

Investigational sites

Application history

1 submissions — initial application plus substantial / non-substantial modifications