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

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 desc

Trial Details

NCT ID
NCT06810583
Phase
PHASE1
Sponsor
St. Jude Children's Research Hospital
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Dalbavancin
  • Fluoroquinolone (either ciprofloxacin or levofloxacin at the discretion of the treating clinician)
Locations (sample)
  • Memphis, Tennessee, United States|35.14953,-90.04898

Key Eligibility Criteria

  • 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.

For full eligibility, visit ClinicalTrials.gov.

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