NCT06810583RecruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 15 Sept 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 29 (estimated)
- First submitted
- 6 Jan 2025
- Start date
- 22 May 2025
- Primary completion date
- Sept 2030
- Lead sponsor
- St. Jude Children's Research Hospital
- NCT number
- NCT06810583
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 29
- From 22 May 2025 to the primary completion date, Sept 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Documented past or current infection or colonization with pathogenic bacteria resistant to vancomycin plus either ciprofloxacin or levofloxacin, within the prior 6 months
Other illness
- Allergy to vancomycin, dalbavancin, teicoplanin, levofloxacin or ciprofloxacin (Not including non-anaphylactic vancomycin infusion reaction)
- Any condition judged by the investigator to put the participant at high risk from participation
- Suspected or proven active bacterial infection
Lab values
- Diagnosed with long QT syndrome
- 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
- Inability to complete requirements of participation in the study (in the opinion of the investigator)
- Expected survival \<28 days
- Other absolute contraindication to administration of fluoroquinolone antibiotics or dalbavancin
- Participant is pregnant or breastfeeding a child
Who the study is looking for
- 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.
Age in the registry: - to 25 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St. Jude Children's Research Hospital Coordinator of this site? Confirm its status | Memphis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.