Personalized dosing of cancer and infection drugs in children with blood cancers
Dose Individualization of Antineoplastic Drugs and Anti-Infective Drug in Children With Hematoplastic Disease
This study is testing if giving children with blood cancers personalized doses of their cancer and infection medications can improve their treatment results and safety.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 1500 (estimated) |
| Ages | 1 Day to 18 Years |
| Sex | All |
| Sponsor | Shandong University Academic / other |
| Locations | 2 sites (Xuzhou, Jiangsu and 1 other locations) |
| Trial ID | NCT03844360 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the feasibility of customizing dosages of commonly used antineoplastic and anti-infective medications for children diagnosed with hematological neoplasms. By employing an opportunistic sampling strategy, the researchers will assess how individualized dosing can improve treatment outcomes. The study will involve various interventions, including drugs like Bortezomib and Imatinib, to determine the most effective dosages for each patient. The goal is to enhance the efficacy and safety of treatments in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are children diagnosed with hematological neoplasms who are undergoing treatment with antineoplastic or anti-infective drugs.
Not a fit: Patients with a life expectancy of less than the treatment cycle or those deemed unsuitable by the researchers may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and safer treatment regimens for children with hematological cancers.
How similar studies have performed: While the approach of dosage individualization is gaining traction, this specific study's methodology is relatively novel and has not been extensively tested in similar populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients must be diagnosed with hematological neoplasms * Antineoplastic drugs or anti-infective drugs used as part of regular treatment Exclusion Criteria: * expected survival time less than the treatment cycle; * patients with other factors that researcher considers unsuitable for inclusion.
Where this trial is running
Xuzhou, Jiangsu and 1 other locations
- Department of Pediatrics, the Affiliated Hospital of Xuzhou Medical University — Xuzhou, Jiangsu, China (Completed)
- State Key Laboratory of Experimental Haematology, Department of Paediatric Haematology, Institute of Haematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College — Tanjin, Tianjin Municipality, China (Recruiting)
Study contacts
- Principal investigator: Wei Zhao, Ph.D — Shandong University
- Study coordinator: Wei Zhao, Ph.D
- Email: zhao4wei2@hotmail.com
- Phone: 86053188383308
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.