LeukemiaPhase 1NCT06810583
A Prospective Trial of Dalbavancin-Based Prophylaxis in Children and Adolescents With High-Risk Leukemia
A Phase 1 study testing Dalbavancin and Fluoroquinolone (either ciprofloxacin or levofloxacin at the discretion of the treating clinician) in people with Leukemia and Acute Myeloid Leukemia, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 25 years
- Conditions the study is for
- Leukemia, Acute Myeloid Leukemia, Lymphoblastic Leukemia in Children
- What is being tested?
- Dalbavancin and Fluoroquinolone (either ciprofloxacin or levofloxacin at the discretion of the treating clinician)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2025to Sep 2031
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
- Suspected or proven active bacterial infection
- Inability to complete requirements of participation in the study (in the opinion of the investigator)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Rohith Jesudas, MBBS, 866-278-5833, referralinfo@stjude.org
About this study
Official title: A Prospective, Single-Arm, Trial of Dalbavancin-Based Prophylaxis in Children and Adolescents With High-Risk Leukemia
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:
Read more
- 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
Read the detailed description
Single-arm, open label, prospective, study with q28 days dalbavancin plus fluoroquinolone (either ciprofloxacin or levofloxacin at the discretion of the treating clinician) for up to 3 doses (12 weeks). Primary outcome will be rate of bacterial bloodstream infection during the first 56 days, with comparison to historical control receiving vancomycin-based prophylaxis (matched St. Jude cohort), or levofloxacin prophylaxis (published data Alexander et al, JAMA, 2018).
Participants will be enrolled, and consent obtained by experienced study staff. Baseline samples, including stool, will be collected within 72 hours after the first dose of dalbavancin. Participants will receive up to 3 doses of q28 days dalbavancin, plus ciprofloxacin or levofloxacin at the discretion of the treating clinician, until 12 weeks or other off study criteria are met. PK samples will be obtained after the first dose of dalbavancin and immediately prior to each subsequent dose. Participants will be monitored for adverse events related to dalbavancin, but adverse events directly related to leukemia or cancer therapy will not be reported.
- Being tested
- Dalbavancin, Fluoroquinolone (either ciprofloxacin or levofloxacin at the discretion of the treating clinician)
- Medical subject headings
- Leukemia, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DalbavancinDrug
3 doses of q28 days dalbavancin (12 weeks).
Fluoroquinolone (either ciprofloxacin or levofloxacin at the discretion of the treating clinician)Drug
28 days dalbavancin plus fluoroquinolone (either ciprofloxacin or levofloxacin at the discretion of the treating clinician) for up to 3 doses (12 weeks).
| Study group | Role | What they receive |
|---|---|---|
| q28 days dalbavancin plus fluoroquinolone | Experimental | Dalbavancin given at standard treatment doses once every 28 days in combination with standard of care fluoroquinolone (ciprofloxacin or levofloxacin) prophylaxis. Receives: Drug: Dalbavancin; Drug: Fluoroquinolone (either ciprofloxacin or levofloxacin at the discretion of the treating clinician) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial bloodstream infection
Proportion of evaluable participants with bacterial bloodstream infection with 95% confidence intervals
Measured: Day 56
Secondary outcomes (6)
Tolerability of dalbavancin
Proportion of evaluable participants with adverse events attributable to dalbavancin with 95% confidence intervals
Measured: Day 56
Acceptability of dalbavancin prophylaxis
Median and range of TSQM II results
Measured: Day 56
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
Measured: Day 84
Dalbavancin peak plasma concentration (Cmax) - Median and range
Peak concentration of dalbavancin 30-60 minutes after completion of dose administration
Measured: Once
Dalbavancin trough plasma concentration (Cmin)- Median and range
Trough concentration of dalbavancin 25-31 days after dose administration
Measured: Up to 3 occasions over 87 days
Dalbavancin area under the concentration-time curve - Median and range
Estimated area under dalbavancin concentration-time curve
Measured: Once following first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start22 May 2025
- Primary completionSep 2030 (estimated)
- Study completionSep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joshua Wolf, MBBS, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06810583
- Sponsor's protocol ID
- DAPHNE
- Status last verified
- Sep 2026
- First submitted
- 6 Jan 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No