NCT06810583 A Prospective Trial of Dalbavancin-Based Prophylaxis in Children and Adolescents With High-Risk Leukemia
| NCT ID | NCT06810583 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | St. Jude Children's Research Hospital |
| Condition | Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 29 participants |
| Start Date | 2025-05-22 |
| Primary Completion | 2030-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 29 participants in total. It began in 2025-05-22 with a primary completion date of 2030-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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
Contact & Investigator
Joshua Wolf, MBBS
PRINCIPAL INVESTIGATOR
St. Jude Children's Research Hospital
Frequently Asked Questions
Who can join the NCT06810583 clinical trial?
This trial is open to participants of all sexes, up to 25 Years, studying Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06810583 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06810583 currently recruiting?
Yes, NCT06810583 is actively recruiting participants. Contact the research team at referralinfo@stjude.org for enrollment information.
Where is the NCT06810583 trial being conducted?
This trial is being conducted at Memphis, United States.
Who is sponsoring the NCT06810583 clinical trial?
NCT06810583 is sponsored by St. Jude Children's Research Hospital. The principal investigator is Joshua Wolf, MBBS at St. Jude Children's Research Hospital. The trial plans to enroll 29 participants.
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