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New treatment option for Acute Myeloid Leukemia
Official title 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)
ClinicalTrials.gov ID: NCT07306832
What this study is testing
What is Pivekimab Sunirine?
Pivekimab Sunirine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute myeloid leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 17
You may be able to join if
- 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.
You likely can't join if
- 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 without evidence of active GvHD at the time of screening and...
See the full eligibility 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) 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...
- 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...
- 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 without evidence of active GvHD at the time of screening and the participant is off medications to treat or prevent either...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
- Valhalla, New York, United States
- Nashville, Tennessee, United States
- Perth, Western Australia, Australia
- Rome, Roma, Italy
- Seoul, Seoul Teugbyeolsi, South Korea
- Taipei, Taiwan
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, 6 months to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, United States; Valhalla, New York, United States; Nashville, Tennessee, United States; Perth, Western Australia, Australia; Rome, Roma, Italy; Seoul, Seoul Teugbyeolsi, South Korea and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.