Prophylaxis with Dalbavancin for Children with High-Risk Leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of dalbavancin-based prophylaxis in preventing bacterial bloodstream infections in children and adolescents with acute myeloid leukemia or relapsed lymphoblastic leukemia undergoing myelosuppressive chemotherapy. Participants will receive dalbavancin every 28 days for up to 12 weeks, alongside a fluoroquinolone antibiotic, while their pharmacokinetics, tolerability, and acceptability will be assessed. The primary outcome is the rate of bacterial infections during the first 56 days compared to historical controls. The study aims to provide insights into the safety and efficacy of this prophylactic approach in a vulnerable pediatric population.

Why it matters

Who can join: the full rules

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, within the prior 6 months
* 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

Where it's running

• St. Jude Children's Research Hospital
  Memphis, Tennessee, United States Recruiting

Study contacts

• Principal investigator: Joshua Wolf, MBBS — St. Jude Children's Research Hospital
• Study coordinator: Joshua Wolf, MBBS
• Email: referralinfo@stjude.org
• Phone: 8662785833

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.