BridgeMD
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)
EU CTIS ID: 2024-520125-36-00
What this study is testing
To determine the safety and pharmacokinetic profile of PVEK in pediatric subjects with relapsed/refractory CD-123-positive AML
- Human Pharmacology (Phase I)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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)
- Participants must have myeloid leukemic blasts that are CD123-positive by flow cytometry as determined by the treating institution.
- Participant 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.
- 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.
You likely can't join if
- Participant has known clinically significant cardiac disease.
- Participant with Down syndrome
- Participant has acute promyelocytic leukemia (APL) or juvenile myelomonocytic leukemia (JMML)
- Participant has symptomatic central nervous system (CNS3) disease
- Participant has prior history of any severity VOD/SOS (veno-occlusive disease/sinusoidal obstructive syndrome) of the liver.
- Participants who have received prior CAR-T therapy
The study team makes the final eligibility decision.
Where it's taking place
- Taiwan
- United Kingdom
- Australia
- Korea, Republic of
- United States
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taiwan; United Kingdom; Australia; Korea, Republic of; United States; Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.