Prophylaxis with Dalbavancin for Children with High-Risk Leukemia
A Prospective, Single-Arm, Trial of Dalbavancin-Based Prophylaxis in Children and Adolescents With High-Risk Leukemia
This study is testing if giving dalbavancin to children with high-risk leukemia can help prevent serious bacterial infections while they are getting chemotherapy.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 29 (estimated) |
| Ages | N/A to 25 Years |
| Sex | All |
| Sponsor | St. Jude Children's Research Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Memphis, Tennessee) |
| Trial ID | NCT06810583 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 25 years or younger receiving treatment for acute myeloid leukemia or relapsed lymphoblastic leukemia at St. Jude Children's Research Hospital.
Not a fit: Patients with allergies to the study drugs or those with active bacterial infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of bacterial infections in high-risk pediatric leukemia patients undergoing chemotherapy.
How similar studies have performed: While this specific approach is novel, similar prophylactic strategies have shown promise in other studies involving pediatric patients with leukemia.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Memphis, Tennessee
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.