BridgeMD
New treatment option for Leukemia
Official title A Prospective Trial of Dalbavancin-Based Prophylaxis in Children and Adolescents With High-Risk Leukemia
ClinicalTrials.gov ID: NCT06810583
What this study is testing
What is Dalbavancin?
Dalbavancin is an investigational medicine, being studied as a potential treatment for leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 25
You may be able to join if
- 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.
You likely can't join if
- 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)
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Memphis, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 25 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Memphis, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.