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

Launched by ST. JUDE CHILDREN'S RESEARCH HOSPITAL · Jan 31, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at the use of a medication called dalbavancin to help prevent serious bacterial infections in children and young adults who are being treated for high-risk leukemia, specifically acute myeloid leukemia (AML) or relapsed lymphoblastic leukemia (ALL). The trial will follow participants who are undergoing chemotherapy, which often weakens the immune system and increases the risk of infections. The main goal is to see how effective dalbavancin is at reducing the chance of these infections during treatment.

Eligible participants must be 25 years old or younger and currently receiving treatment for AML or relapsed ALL at St. Jude Children’s Research Hospital. They should expect to experience severe low blood cell counts (neutropenia) due to their chemotherapy. Participants will receive dalbavancin every 28 days for up to 12 weeks and will have their health monitored to assess how well they tolerate the medication and how effective it is in preventing infections. It’s important to note that individuals with certain allergies or specific health conditions might not be able to participate. Overall, this trial aims to improve the care and outcomes for young patients facing these challenging cancers.

Gender

ALL

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