Actively Recruiting
A Prospective, Single-Arm Trial of Dalbavancin-Based Prophylaxis in Children and Adolescents With High-Risk Leukemia
Led by St. Jude Children's Research Hospital · Updated on 2026-02-03
29
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial evaluates dalbavancin-based prophylaxis in children and adolescents with acute myeloid leukemia (AML) or relapsed lymphoblastic leukemia (ALL) who are receiving chemotherapy that suppresses bone marrow activity. It is a single-arm, open-label, phase 1 study aiming to estimate the rate of bacterial bloodstream infection in this high-risk pediatric population. The study also explores dalbavancin's pharmacokinetics, tolerability, and acceptability when given every 28 days during chemotherapy. Participants receive dalbavancin at standard treatment doses once every 28 days for up to three doses over 12 weeks, combined with a fluoroquinolone antibiotic (ciprofloxacin or levofloxacin) chosen by the treating clinician. Baseline stool and other samples are collected within 72 hours after the first dalbavancin dose. Pharmacokinetic blood samples are taken after the first dose and before each subsequent dose to monitor drug levels. The study compares infection rates to historical controls receiving vancomycin or levofloxacin prophylaxis. During the study, participants are monitored for bacterial bloodstream infections primarily through day 56. Researchers also assess tolerability and acceptability of dalbavancin, along with rates of other likely bacterial infections, Clostridioides difficile infection, and febrile neutropenia by day 84. Adverse events related to dalbavancin are recorded, excluding those related to leukemia or chemotherapy. The total participation period includes up to 12 weeks of treatment and follow-up for safety and outcome assessments.
CONDITIONS
Brief Title
A Prospective Trial of Dalbavancin-Based Prophylaxis in Children and Adolescents With High-Risk Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged less than or equal to 25 years at enrollment
- Receiving treatment for AML or relapsed ALL expected to cause severe neutropenia lasting more than 7 days
- Expected to receive care at the study site for at least 56 days after enrollment
- Female participants aged 9 years or older must have a documented negative pregnancy test before receiving the study drug
You will not qualify if you...
- Allergy to vancomycin, dalbavancin, teicoplanin, levofloxacin, or ciprofloxacin (excluding non-anaphylactic vancomycin infusion reactions)
- Past or current infection or colonization with bacteria resistant to vancomycin plus ciprofloxacin or levofloxacin
- Diagnosis of long QT syndrome
- Any condition the investigator believes makes participation high risk
- Suspected or proven active bacterial infection
- Inability to meet study participation requirements
- Expected survival less than 28 days
- Liver enzymes or bilirubin levels 3 times or more above normal for age
- Estimated kidney function below 30 mL/min/1.73 m2
- Other absolute contraindications to fluoroquinolone or dalbavancin use
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks
Participants receive up to 3 doses of dalbavancin once every 28 days combined with fluoroquinolone prophylaxis for up to 12 weeks.
3 visits for dalbavancin dosing every 28 days plus additional monitoring visits as needed
Trial Site Locations
Total: 1 location
1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
Research Team
J
Joshua Wolf, MBBS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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