Pharmacokinetic Analysis of High Dose Methotrexate in Pediatric Lymphoblastic Malignancies
- Conditions
- Methotrexate Adverse Reaction
- Interventions
- Drug: 3g MTXDrug: 5g MTX
- Registration Number
- NCT02011022
- Lead Sponsor
- The Children's Hospital of Zhejiang University School of Medicine
- Brief Summary
\* The pharmacokinetics of MTX were assessed with regards to the relevance of several different patient specific factors in 291 pediatric patients, who were administered with high dose of MTX. Population pharmacokinetics of MTX analysis was performed by using nonlinear mixed effects modeling.
- Detailed Description
* Methotrexate (MTX) is one of the critical components for treating all forms of acute lymphoblastic leukemia (ALL), which is the most common pediatric cancer. Unfortunately, high dose MTX has several undesirable side effects and MTX toxicity vastly differs from patient to patient.
* The pharmacokinetics of MTX were assessed with regards to the relevance of several different patient specific factors in 291 pediatric patients, who were administered with high dose of MTX. Population pharmacokinetics of MTX analysis was performed by using nonlinear mixed effects modeling.
* The final model was validated using nonparametric bootstrap analysis. Body surface area (BSA), pre-hydration, baseline serum creatinine and 24 h creatinine clearance rate were statistically significant covariates for distributional volume (V) and renal clearance (CL). Herein, is the first report of analysis of the importance of a series of patient factors on pharmacokinetics of MTX by one-compartment model. Using these data, we have established an efficient population pharmacokinetic model for MTX, which can be used to predict safe clinical application of MTX especially in children with ALL.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 291
- Acute lymphoblastic leukemia and non-hodgkin's lymphoma younger than 18 years old
- Non lymphoblastic malignancies or older than 18 years
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3g group 3g MTX The dose of MTX is 3 g/m2 5g group 5g MTX The dose of MTX is 5g/m2
- Primary Outcome Measures
Name Time Method elimination delay 3 days The serum MTX is higher than 1umol/L in 48 hours or 0.1umol/L in 96 hours
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The Children's Hospital of Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China