Dalbavancin for Childhood Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a treatment called dalbavancin (an antibiotic) in children and adolescents with specific types of leukemia (a blood cancer). The goal is to determine if dalbavancin can prevent bacterial infections during chemotherapy, a time when the immune system is weak. Researchers aim to learn more about how the body processes the drug and how well patients tolerate it. Children and teens with either acute myeloid leukemia or relapsed lymphoblastic leukemia undergoing chemotherapy might be suitable for this study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to contribute to groundbreaking research.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
Is there any evidence suggesting that dalbavancin is likely to be safe for children and adolescents with leukemia?
Research has shown that dalbavancin is generally safe for children. Past studies found no serious side effects linked to dalbavancin in children, and hearing tests revealed no issues. Some studies found that children have about 30% less dalbavancin in their bodies compared to adults, but it remains safe. Dalbavancin is already used to treat serious skin infections, indicating its safety. However, since this trial is in an early stage, the researchers are primarily focused on understanding its safety and determining the right dose, so they will closely monitor participants.12345
Why do researchers think this study treatment might be promising?
Dalbavancin is unique because it's an antibiotic that's being tested for its potential to help treat childhood leukemia, specifically to prevent infections during treatment. Unlike other standard treatments for leukemia that focus solely on chemotherapy, dalbavancin works by targeting bacterial infections, which can be a serious complication for kids undergoing cancer treatment. Researchers are excited about dalbavancin because it is administered once every 28 days, potentially offering a more convenient and less frequent dosing schedule compared to other antibiotics. This can make it easier for young patients and their families to manage during an already challenging time.
What evidence suggests that dalbavancin might be an effective treatment for childhood leukemia?
Research shows that dalbavancin can help prevent serious infections in children with leukemia. Previous studies have found that dalbavancin is safe and effective for treating complex infections caused by certain bacteria in children. It has also been used to shorten hospital stays, indicating effective infection management. In this trial, participants will receive dalbavancin every 28 days alongside standard fluoroquinolone prophylaxis. Reducing infections is vital for children with leukemia because chemotherapy weakens their immune systems. These findings offer hope that dalbavancin could protect against bacterial infections during cancer treatment.14678
Who Is on the Research Team?
Joshua Wolf, MBBS
Principal Investigator
St. Jude Children's Research Hospital
Are You a Good Fit for This Trial?
This trial is for children and adolescents with high-risk leukemia, specifically acute myeloid leukemia (AML) or relapsed lymphoblastic leukemia (ALL), who are undergoing strong chemotherapy. Participants must be able to receive dalbavancin-based prophylaxis.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive dalbavancin every 28 days in combination with fluoroquinolone for up to 3 doses (12 weeks)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including adverse events and infection rates
What Are the Treatments Tested in This Trial?
Interventions
- Dalbavancin
Find a Clinic Near You
Who Is Running the Clinical Trial?
St. Jude Children's Research Hospital
Lead Sponsor