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

A Prospective, Single-Arm, 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 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

Study Overview

• Status: Recruiting
• Conditions: Acute Myeloid Leukemia; Leukemia; Lymphoblastic Leukemia in Children
• Intervention / Treatment: Drug: Dalbavancin; Drug: Fluoroquinolone (either ciprofloxacin or levofloxacin at the discretion of the treating clinician)

Detailed Description

Single-arm, open label, prospective, study with q28 days dalbavancin plus fluoroquinolone (either ciprofloxacin or levofloxacin at the discretion of the treating clinician) for up to 3 doses (12 weeks). Primary outcome will be rate of bacterial bloodstream infection during the first 56 days, with comparison to historical control receiving vancomycin-based prophylaxis (matched St. Jude cohort), or levofloxacin prophylaxis (published data Alexander et al, JAMA, 2018).

Participants will be enrolled, and consent obtained by experienced study staff. Baseline samples, including stool, will be collected within 72 hours after the first dose of dalbavancin. Participants will receive up to 3 doses of q28 days dalbavancin, plus ciprofloxacin or levofloxacin at the discretion of the treating clinician, until 12 weeks or other off study criteria are met. PK samples will be obtained after the first dose of dalbavancin and immediately prior to each subsequent dose. Participants will be monitored for adverse events related to dalbavancin, but adverse events directly related to leukemia or cancer therapy will not be reported.

• Study Type: Interventional
• Enrollment (Estimated): 29
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Joshua Wolf, MBBS; Phone Number: 8662785833; Email: referralinfo@stjude.org

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • Recruiting
      • St. Jude Children's Research Hospital
      • Contact: Rohith Jesudas, MBBS; Phone Number: 866-278-5833; Email: referralinfo@stjude.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion 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.

Exclusion Criteria:

• Allergy to vancomycin, dalbavancin, teicoplanin, levofloxacin or ciprofloxacin (Not including non-anaphylactic vancomycin infusion reaction)
• Documented past or current infection or colonization with pathogenic bacteria resistant to vancomycin plus either ciprofloxacin or levofloxacin
• Diagnosed with long QT syndrome
• Any condition judged by the investigator to put the participant at high risk from participation
• Suspected or proven active bacterial infection
• Inability to complete requirements of participation in the study (in the opinion of the investigator)
• Expected survival <28 days
• 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
• Other absolute contraindication to administration of fluoroquinolone antibiotics or dalbavancin
• Participant is pregnant or breastfeeding a child

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: q28 days dalbavancin plus fluoroquinolone; Dalbavancin given at standard treatment doses once every 28 days in combination with standard of care fluoroquinolone (ciprofloxacin or levofloxacin) prophylaxis.	Drug: Dalbavancin; 3 doses of q28 days dalbavancin (12 weeks).; Drug: Fluoroquinolone (either ciprofloxacin or levofloxacin at the discretion of the treating clinician); 28 days dalbavancin plus fluoroquinolone (either ciprofloxacin or levofloxacin at the discretion of the treating clinician) for up to 3 doses (12 weeks).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bacterial bloodstream infection	Proportion of evaluable participants with bacterial bloodstream infection with 95% confidence intervals	Day 56

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerability of dalbavancin	Proportion of evaluable participants with adverse events attributable to dalbavancin with 95% confidence intervals	Day 56
Acceptability of dalbavancin prophylaxis	Median and range of TSQM II results	Day 56
Likely bacterial infections, Clostridioides difficile infection, and febrile neutropenia	Proportion of evaluable participants with likely bacterial infections, Clostridioides difficile infection, or febrile neutropenia, with 95% confidence intervals	Day 84
Dalbavancin peak plasma concentration (Cmax) - Median and range	Peak concentration of dalbavancin 30-60 minutes after completion of dose administration	Once
Dalbavancin trough plasma concentration (Cmin)- Median and range	Trough concentration of dalbavancin 25-31 days after dose administration	Up to 3 occasions over 87 days
Dalbavancin area under the concentration-time curve - Median and range	Estimated area under dalbavancin concentration-time curve	Once following first dose

Collaborators and Investigators

• Sponsor: St. Jude Children's Research Hospital
• Investigators: Principal Investigator: Joshua Wolf, MBBS, St. Jude Children's Research Hospital

Publications and helpful links

Helpful Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2025
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2031

Study Registration Dates

• First Submitted: January 6, 2025
• First Submitted That Met QC Criteria: January 31, 2025
• First Posted (Actual): February 5, 2025

Study Record Updates

• Last Update Posted (Actual): February 3, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Hematologic Diseases; Leukemia, Myeloid; Hemic and Lymphatic Diseases; Leukemia; Leukemia, Myeloid, Acute; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; 4-Quinolones; Quinolones; Quinolines; Fluoroquinolones; dalbavancin
• Other Study ID Numbers: DAPHNE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No