Dalbavancin Prophylaxis for High-Risk Leukemia in Children and Adolescents

This study is testing if a medication called dalbavancin, given with a fluoroquinolone (like ciprofloxacin or levofloxacin), can help prevent serious bacterial bloodstream infections in children and adolescents with acute myeloid leukemia (AML) or relapsed acute lymphoblastic leukemia (ALL). These patients are at high risk for infection because their chemotherapy causes a severe drop in white blood cells (severe neutropenia). The study aims to see how well dalbavancin prevents these infections and how well patients tolerate it. You might be able to join if you are 25 years old or younger, have AML or relapsed ALL, and are receiving treatment at St. Jude that is expected to cause prolonged severe neutropenia. The study is currently unclear on its status and plans to enroll 29 participants.

Study design
This is a single-arm, open-label study, meaning all participants receive the same treatment and both you and your doctors will know what you are receiving. It plans to enroll 29 participants.
What's involved
You would receive up to three doses of dalbavancin every 28 days, along with a fluoroquinolone, for up to 12 weeks. Baseline samples, including stool, will be collected, and blood samples will be taken to see how the drug moves through your body.
Compensation
Not stated in the trial record.
Follow-up
The primary goal is to measure bacterial bloodstream infections at Day 56. Participants will receive treatment for up to 12 weeks.

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NCT06810583

A Prospective Trial of Dalbavancin-Based Prophylaxis in Children and Adolescents With High-Risk Leukemia

Recruiting
PHASE1Up to 25InterventionalTreatment
St. Jude Children's Research Hospital
~29 participants
Updated 2026-02-03 on ClinicalTrials.gov
What's tested:DalbavancinFluoroquinolone (either ciprofloxacin or levofloxacin at the discretion of the treating clinician)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Bacterial bloodstream infection
Measured over Day 56
Leukemia
Acute Myeloid Leukemia
Lymphoblastic Leukemia in Children
1 sites across 1 states
Tennessee1
  • Joshua Wolf, MBBS · PRINCIPAL_INVESTIGATOR · St. Jude Children's Research Hospital

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Eligibility criteria

Inclusion

Aged less than or equal to 25 years at enrollment
Receiving treatment for AML or relapsed ALL at St. Jude and treatment is expected to cause prolonged (\> 7 days) severe neutropenia (ANC \< 500/ml)
Expected to receive care at St. Jude for at least 56 days following enrollment on the protocol
Female participant, greater than or equal to 9 years old, has a documented negative pregnancy test prior to receipt of study drug.

Exclusion

Allergy to vancomycin, dalbavancin, teicoplanin, levofloxacin or ciprofloxacin (Not including non-anaphylactic vancomycin infusion reaction)
Documented past or current infection or colonization with pathogenic bacteria resistant to vancomycin plus either ciprofloxacin or levofloxacin
Diagnosed with long QT syndrome
Any condition judged by the investigator to put the participant at high risk from participation
Suspected or proven active bacterial infection
Inability to complete requirements of participation in the study (in the opinion of the investigator)
Expected survival \<28 days
Alkaline phosphatase, alanine transferase or total bilirubin ≥ 3x upper limit of normal for age
Estimated glomerular filtration rate (EGFR) \<30 mL/minute/1.73 m2
Other absolute contraindication to administration of fluoroquinolone antibiotics or dalbavancin
Participant is pregnant or breastfeeding a child
  • Bacterial bloodstream infectionDay 56

    Proportion of evaluable participants with bacterial bloodstream infection with 95% confidence intervals