RecruitingPhase 1NCT06810583

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

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

Sponsor

St. Jude Children's Research Hospital

Enrollment

29 participants

Start Date

May 22, 2025

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia Leukemia Lymphoblastic Leukemia in Children

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. 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

Max Age: 25 Years

Plain Language Summary

Simplified for easier understanding

This study is testing dalbavancin as a preventive antibiotic treatment in children undergoing certain high-risk medical procedures. Dalbavancin is a long-acting antibiotic given by IV that stays active in the body for weeks, potentially preventing serious bacterial infections. **You may be eligible if...** - Your child is scheduled for a high-risk procedure and the study team determines preventive antibiotics are appropriate - Your child meets the age and weight criteria for the study - You are willing to provide consent and your child (if old enough) agrees to participate **You may NOT be eligible if...** - Your child has a known allergy to dalbavancin or related antibiotics - Your child has significant kidney or liver problems - Your child is currently enrolled in another clinical study - There are other medical reasons that make dalbavancin unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGDalbavancin

3 doses of q28 days dalbavancin (12 weeks).

DRUGFluoroquinolone (either ciprofloxacin or levofloxacin at the discretion of the treating clinician)

28 days dalbavancin plus fluoroquinolone (either ciprofloxacin or levofloxacin at the discretion of the treating clinician) for up to 3 doses (12 weeks).

Locations(1)

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06810583

Related Trials

Testing the Effects of Novel Therapeutics for Newly Diagnosed, Untreated Patients With High-Risk Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial)

NCT05554406220 locations

Cognitive Aftereffects of Neurotoxicity in Children and Young Adults With Relapsed/Refractory Hematologic Malignancies Who Receive CAR T-cell Therapy

NCT052379863 locations

Comparing Cytarabine + Daunorubicin Therapy Versus Cytarabine + Daunorubicin + Venetoclax Versus Venetoclax + Azacitidine in Younger Patients With Intermediate Risk AML (A MyeloMATCH Treatment Trial)

NCT05554393177 locations

MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)

NCT05564390346 locations

Venetoclax and HMA Treatment of Older and Unfit Adults With FLT3 Mutated Acute Myeloid Leukemia (AML) (A MyeloMATCH Treatment Trial)

NCT06317649220 locations