Pharmacokinetic Analysis of High Dose Methotrexate in Pediatric Lymphoblastic Malignancies
NCT ID: NCT02011022
Last Updated: 2013-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
291 participants
INTERVENTIONAL
2009-05-31
2010-02-28
Brief Summary
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Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
NONE
Study Groups
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3g group
The dose of MTX is 3 g/m2
3g MTX
The group of patients which are treated with 3g/m2 MTX, low risk ALL or NHL
5g group
The dose of MTX is 5g/m2
5g MTX
The group of patients which are treated with 5g/m2 MTX, they are high or middle risk ALL patients
Interventions
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3g MTX
The group of patients which are treated with 3g/m2 MTX, low risk ALL or NHL
5g MTX
The group of patients which are treated with 5g/m2 MTX, they are high or middle risk ALL patients
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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The Children's Hospital of Zhejiang University School of Medicine
OTHER
Responsible Party
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Weiqun Xu
Doctor
Principal Investigators
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Weiqun Xu
Role: PRINCIPAL_INVESTIGATOR
The Children's Hospital of Zhejiang University School of Medicine
Locations
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The Children's Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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References
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Yanagimachi M, Goto H, Kaneko T, Naruto T, Sasaki K, Takeuchi M, Tanoshima R, Kato H, Yokosuka T, Kajiwara R, Fujii H, Tanaka F, Goto S, Takahashi H, Mori M, Kai S, Yokota S. Influence of pre-hydration and pharmacogenetics on plasma methotrexate concentration and renal dysfunction following high-dose methotrexate therapy. Int J Hematol. 2013 Dec;98(6):702-7. doi: 10.1007/s12185-013-1464-z. Epub 2013 Nov 16.
Related Links
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Another related article
Other Identifiers
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chzj-HDMTX-20131205
Identifier Type: -
Identifier Source: org_study_id