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OncoMatch/Clinical Trials/NCT06810583

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

Is NCT06810583 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Dalbavancin and Fluoroquinolone (either ciprofloxacin or levofloxacin at the discretion of the treating clinician) for leukemia.

Phase 1RecruitingSt. Jude Children's Research HospitalNCT06810583Data as of May 2026

Treatment: Dalbavancin · Fluoroquinolone (either ciprofloxacin or levofloxacin at the discretion of the treating clinician)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

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Acute Lymphoblastic Leukemia

Lab requirements

Blood counts

treatment is expected to cause prolonged (> 7 days) severe neutropenia (ANC < 500/ml)

Kidney function

Estimated glomerular filtration rate (EGFR) <30 mL/minute/1.73 m2 [excluded]

Liver function

Alkaline phosphatase, alanine transferase or total bilirubin ≥ 3x upper limit of normal for age [excluded]

Cardiac function

Diagnosed with long QT syndrome [excluded]

treatment is expected to cause prolonged (> 7 days) severe neutropenia (ANC < 500/ml); 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; Diagnosed with long QT syndrome

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • St. Jude Children's Research Hospital · Memphis, Tennessee

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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