RECRUITING · INTERVENTIONAL · TREATMENT study · Leukemia · Phase 1 · Enrollment 29 · Sponsor: St. Jude Children's Research Hospital
Official title: A Prospective, Single-Arm, Trial of Dalbavancin-Based Prophylaxis in Children and Adolescents With High-Risk Leukemia
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
Conditions: Leukemia, Acute Myeloid Leukemia, Lymphoblastic Leukemia in Children
Study type: INTERVENTIONAL
Primary purpose: TREATMENT
Phases: PHASE1
Enrollment: 29 (ESTIMATED)
Status: RECRUITING
Completion: 2031-09 (ESTIMATED)