Actively Recruiting
A Prospective 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
327 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-arm pilot clinical trial evaluating dalbavancin-based prophylaxis in children and adolescents with acute myeloid leukemia or relapsed lymphoblastic leukemia receiving myelosuppressive chemotherapy. Primary objective: \- To estimate the rate of bacterial bloodstream infection in pediatric patients with AML or relapsed ALL undergoing chemotherapy receiving dalbavancin-based prophylaxis Secondary objectives: * To describe the population pharmacokinetics of every 28 days dalbavancin up to 12 weeks in pediatric patients with AML or relapsed ALL undergoing chemotherapy * To describe the tolerability of every 28 days dalbavancin prophylaxis in pediatric patients with AML or relapsed ALL undergoing chemotherapy * To describe the acceptability of every 28 days dalbavancin prophylaxis in pediatric patients with AML or relapsed ALL undergoing chemotherapy * To estimate the rates of likely bacterial infections, Clostridioides difficile infection, and febrile neutropenia in pediatric patients receiving dalbavancin-based prophylaxis
CONDITIONS
Official 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 acute myeloid leukemia or relapsed lymphoblastic leukemia at St. Jude with expected prolonged (more than 7 days) severe neutropenia (ANC less than 500/ml)
- Expected to receive care at St. Jude for at least 56 days after enrollment
- Female participants 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 considered by the investigator to pose high risk for participation
- Suspected or proven active bacterial infection
- Inability to complete study participation requirements
- Expected survival less than 28 days
- Alkaline phosphatase, alanine transferase, or total bilirubin levels three times or more above the age limit
- Estimated glomerular filtration rate less than 30 mL/minute/1.73 m2
- Any absolute contraindication to fluoroquinolone antibiotics or dalbavancin
- Pregnant or breastfeeding
AI-Screening
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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
CONTACT
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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