Condition: Leukemia · Acute Myeloid Leukemia · Lymphoblastic Leukemia in Children · Sponsor: St. Jude Children's Research Hospital
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
This description comes directly from the study's public registry record.
Joshua Wolf, MBBS · 8662785833 · referralinfo@stjude.org
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| St. Jude Children's Research Hospital | Memphis, Tennessee, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06810583