A Prospective Trial of Dalbavancin-Based Prophylaxis in Children and Adolescents With High-Risk Leukemia
A Prospective, Single-Arm, Trial of Dalbavancin-Based Prophylaxis in Children and Adolescents With High-Risk Leukemia
St. Jude Children's Research Hospital
29 participants
May 22, 2025
INTERVENTIONAL
Conditions
Summary
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
Eligibility
Inclusion Criteria4
- 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 Criteria11
- 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
Interventions
3 doses of q28 days dalbavancin (12 weeks).
28 days dalbavancin plus fluoroquinolone (either ciprofloxacin or levofloxacin at the discretion of the treating clinician) for up to 3 doses (12 weeks).
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06810583