Study of Dalbavancin and Fluoroquinolone Prophylaxis in Children and Young Adults With High-Risk Leukemia Receiving Chemotherapy

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 dalbavancins 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.

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