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

Recruiting now · Phase 1

Conditions studied: Leukemia, Acute Myeloid Leukemia, Lymphoblastic Leukemia in Children

In brief

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

Key facts

Study ID

NCT06810583

Run by

St. Jude Children's Research Hospital

People needed

29

Starts

2025-05-22

Expected to finish

2031-09-01

Last updated by the study team

2026-02-03

Who can join

Age: any, up to 25. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• St. Jude Children's Research Hospital — Memphis, Tennessee, United States (enrolling)

Full record on ClinicalTrials.gov

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