A Prospective Trial of Dalbavancin-Based Prophylaxis in Children and Adolescents With High-Risk Leukemia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
AgeUp to 25
SponsorSt. Jude Children's Research Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Dalbavancin
Drug3 doses of q28 days dalbavancin (12 weeks).
Fluoroquinolone (either ciprofloxacin or levofloxacin at the discretion of the treating clinician)
Drug28 days dalbavancin plus fluoroquinolone (either ciprofloxacin or levofloxacin at the discretion of the treating clinician) for up to 3 doses (12 weeks).
Treatment groups
29 Participants
are divided into 1 treatment groupGroup A: q28 days dalbavancin plus fluoroquinoloneExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Bacterial bloodstream infection
Proportion of evaluable participants with bacterial bloodstream infection with 95% confidence intervals
Time frame
Day 56Secondary outcomes
1
Tolerability of dalbavancin
Proportion of evaluable participants with adverse events attributable to dalbavancin with 95% confidence intervals
Time frame
Day 562
Acceptability of dalbavancin prophylaxis
Median and range of TSQM II results
Time frame
Day 563
Likely bacterial infections, Clostridioides difficile infection, and febrile neutropenia
Proportion of evaluable participants with likely bacterial infections, Clostridioides difficile infection, or febrile neutropenia, with 95% confidence intervals
Time frame
Day 844
Dalbavancin peak plasma concentration (Cmax) - Median and range
Peak concentration of dalbavancin 30-60 minutes after completion of dose administration
Time frame
OnceSponsors and contacts
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Source ClinicalTrials.gov