Clinical trial · Interventional
Pharmacokinetic Analysis of High Dose Methotrexate in Pediatric Lymphoblastic Malignancies
Pharmacokinetic Analysis of High Dose Methotrexate in Pediatric Acute Lymphoblastic Leukemia: Significant Impact Factors and Establishment of a Clinically Relevant Model
NCT02011022CI-TRIAL-00012977HDMTXcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
\* 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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Methotrexate Adverse Reaction | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3g MTX | Drug | Methotrexate | ALIAS |
| 5g MTX | Drug | Methotrexate | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 3g group
- description
- The dose of MTX is 3 g/m2
- interventionNames
- Drug: 3g MTX
- type
- EXPERIMENTAL
- label
- 5g group
- description
- The dose of MTX is 5g/m2
- interventionNames
- Drug: 5g MTX
Primary outcomes (1)
- measure
- elimination delay
- timeFrame
- 3 days
- description
- The serum MTX is higher than 1umol/L in 48 hours or 0.1umol/L in 96 hours
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Acute lymphoblastic leukemia and non-hodgkin's lymphoma younger than 18 years old Exclusion Criteria: * Non lymphoblastic malignancies or older than 18 years
References
Publications (1)
- BACKGROUNDYanagimachi 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. PMID 24241962