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Pharmacokinetic Analysis of High Dose Methotrexate in Pediatric Lymphoblastic Malignancies

NCT02011022 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 291

Last updated 2013-12-13

No results posted yet for this study

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.

Conditions

  • Methotrexate Adverse Reaction

Interventions

DRUG

3g MTX

The group of patients which are treated with 3g/m2 MTX, low risk ALL or NHL

DRUG

5g MTX

The group of patients which are treated with 5g/m2 MTX, they are high or middle risk ALL patients

Sponsors & Collaborators

  • The Children's Hospital of Zhejiang University School of Medicine

    lead OTHER

Principal Investigators

  • Weiqun Xu · The Children's Hospital of Zhejiang University School of Medicine

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2009-12-31
Completion
2010-02-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02011022 on ClinicalTrials.gov