Efficacy, Safety, and Population Pharmacokinetics of Eltrombopag in Children with Different Severities of Aplastic Anemia.
Wei Zhang, Li-Xian Chang, Bei-Bei Zhao...
https://pubmed.ncbi.nlm.nih.gov/38497347Actively Recruiting
Phase 4
Age: 1Day - 18Years
All Genders
ID03844360
Dose Individualization of Antineoplastic and Anti-Infective Drugs in Children With Hematological Neoplasms
Led by Wei Zhao · Updated on 2025-03-30
1500
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
W
Wei Zhao
Lead Sponsor
C
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the feasibility of personalizing doses of common antineoplastic and anti-infective drugs in children diagnosed with or suspected to have hematological neoplasms. The study aims to understand how these drug dosages can be adjusted based on opportunistic sampling strategies to improve treatment management in pediatric hematoplastic disease. Children in the study receive standard doses of several drugs including bortezomib, eltrombopag, imatinib, dasatinib, pegaspargase, and various anti-infective medications. These treatments are administered according to the doctor's advice as part of regular care for hematological neoplasms. Participants will have their blood plasma concentrations of these drugs monitored at multiple specific time points after administration, ranging from minutes to days depending on the drug. The study carefully tracks these levels throughout treatment to evaluate dosage individualization. This phase 4 trial includes children from birth up to 18 years old and does not involve masking or placebo control.
CONDITIONS
Brief Title
Dose Individualization of Antineoplastic Drugs and Anti-Infective Drug in Children With Hematoplastic Disease
Who Can Participate
Age: 1Day - 18Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients must be diagnosed with hematological neoplasms
- Antineoplastic drugs or anti-infective drugs used as part of regular treatment
- Children aged from birth up to 18 years
You will not qualify if you...
- Expected survival time less than the treatment cycle
- Patients with other factors that the researcher considers unsuitable for inclusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 14 days of active dosing based on drug administration and plasma concentration monitoring
Participants receive antineoplastic and anti-infective drugs at standard doses as prescribed by their doctor, with dosing individualized based on drug concentration measurements.
Multiple visits for drug administration and plasma concentration sampling over approximately 14 days
Trial Site Locations
Total: 2 locations
1
Department of Pediatrics, the Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China, 221000
Completed
2
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, 300020
Actively Recruiting
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Research Team
W
Wei Zhao, Ph.D
Y
Yan H Shi, Ph.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Population Pharmacokinetics and Safety of Dasatinib in Chinese Children with Core-Binding Factor Acute Myeloid Leukemia.
Fan Yang, Li Zhang, Bei-Bei Zhao...
https://pubmed.ncbi.nlm.nih.gov/34240339