Understanding how drugs work in children with leukemia
Pharmacokinetics of Drugs Administered to Children Per Standard of Care
This study looks at how well certain leukemia medications work in children under 21 to better understand their safety and effectiveness.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 0 Years to 20 Years |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT03481881 on ClinicalTrials.gov |
What this trial studies
This observational study aims to characterize the pharmacokinetics (PK) of drugs administered to children under 21 years of age who are receiving treatment for pediatric acute lymphoblastic leukemia (ALL). The study will involve monitoring the standard of care drugs prescribed by the treating caregivers to gather data on how these medications are processed in the bodies of young patients. By focusing on understudied drugs, the research seeks to fill gaps in knowledge regarding their effectiveness and safety in this specific population.
Who should consider this trial
Good fit: Ideal candidates for this study are children under 21 years of age who are receiving specific drugs for pediatric ALL as part of their standard treatment.
Not a fit: Patients who are not receiving the drugs of interest or those who cannot provide consent or assent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved drug dosing and treatment strategies for children with leukemia, enhancing their overall care.
How similar studies have performed: While pharmacokinetics studies in pediatric populations are common, this specific focus on understudied drugs in pediatric ALL is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children (\< 21 years of age) who are receiving understudied drugs of interest per standard of care as prescribed by their treating caregiver Exclusion Criteria: * Failure to obtain consent/assent (as indicated)
Where this trial is running
Durham, North Carolina
- Duke University — Durham, North Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Rachel G Greenberg, MD
- Email: rachel.greenberg@duke.edu
- Phone: 9196684725
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.