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

NCT06810583 | Recruiting Phase 1 FDA Drug

• 1 other identifier: DAPHNE
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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

Acute Myeloid Leukemia; Lymphoblastic Leukemia in Children; Leukemia

Outcome Measures

Primary Outcomes (1)

• Bacterial bloodstream infection

  Proportion of evaluable participants with bacterial bloodstream infection with 95% confidence intervals

  Day 56

Secondary Outcomes (6)

• Tolerability of dalbavancin

  Day 56

• Acceptability of dalbavancin prophylaxis

  Day 56

• Likely bacterial infections, Clostridioides difficile infection, and febrile neutropenia

  Day 84

• Dalbavancin peak plasma concentration (Cmax) - Median and range

  Once

• Dalbavancin trough plasma concentration (Cmin)- Median and range

  Up to 3 occasions over 87 days

Study Arms (1)

q28 days dalbavancin plus fluoroquinolone

EXPERIMENTAL

Dalbavancin given at standard treatment doses once every 28 days in combination with standard of care fluoroquinolone (ciprofloxacin or levofloxacin) prophylaxis.

Drug: Dalbavancin; Drug: Fluoroquinolone (either ciprofloxacin or levofloxacin at the discretion of the treating clinician)

Interventions

Fluoroquinolone (either ciprofloxacin or levofloxacin at the discretion of the treating clinician) DRUG

28 days dalbavancin plus fluoroquinolone (either ciprofloxacin or levofloxacin at the discretion of the treating clinician) for up to 3 doses (12 weeks).

q28 days dalbavancin plus fluoroquinolone

Dalbavancin DRUG

3 doses of q28 days dalbavancin (12 weeks).

q28 days dalbavancin plus fluoroquinolone

Eligibility Criteria

• Age: Up to 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

RECRUITING

Related Links

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

MeSH Terms

Conditions

Leukemia; Leukemia, Myeloid, Acute

Interventions

dalbavancin; Fluoroquinolones

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid

Intervention Hierarchy (Ancestors)

4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Joshua Wolf, MBBS

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joshua Wolf, MBBS

CONTACT

8662785833; referralinfo@stjude.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: February 5, 2025
• Study Start: May 22, 2025
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2031
• Last Updated: February 3, 2026

Record last verified: 2026-02

Locations

US (1)