Clinical trial · Observational
Retrospective Registry Study of Patients With Cancer Treated With High-dose Methotrexate
High-dose Methotrexate Patterns of Use, Clearance, Toxicities, Supportive Care and Outcomes
- 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)
This retrospective observational study will evaluate high-dose methotrexate patterns of use, supportive care measures used during high-dose methotrexate chemotherapy, along with the incidence of delayed elimination of methotrexate, acute kidney injury and any associated impact of delayed elimination of methotrexate on future courses of chemotherapy and disease outcomes in adults and children with cancer. The study will compare current practice with existing guidelines and best practices to identify potential gaps in the management of high-dose methotrexate administration and delayed elimination of methotrexate. The study will identify variations in practice and outcomes in different study centers, countries, cancer types, patient age groups, by different methotrexate doses and infusion times and different supportive care measures used. The study will also document the proportion of high-dose methotrexate courses in which glucarpidase has been used and any toxicities attributable to the use of glucarpidase.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Kidney Injury | — | UNRESOLVED | — |
| Drug Toxicity | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Glucarpidase | Drug | — | UNRESOLVED |
| High-dose methotrexate | Drug | Methotrexate | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Patients Treated With High-dose Methotrexate
- description
- Patients with a diagnosis of any cancer receiving high-dose methotrexate chemotherapy.
- interventionNames
- Drug: High-dose methotrexate
- Drug: Glucarpidase
Primary outcomes (3)
- measure
- Delayed Elimination of Methotrexate
- timeFrame
- 0-48 hours from the start of high-dose methotrexate infusion.
- description
- Incidence of delayed elimination of methotrexate after high-dose methotrexate chemotherapy, defined by Ramsey criteria.
- measure
- Acute Kidney Injury
- timeFrame
- 0-48 hours from the start of high-dose methotrexate infusion.
- description
- Incidence of acute kidney injury of any grade after high-dose methotrexate chemotherapy.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * A diagnosis of any cancer from January 1, 2001 to June 30, 2021. * Receipt of high-dose methotrexate chemotherapy, defined as a dose of 500 mg/m2 of body surface area or higher. * Medical records available for review. * Any age; any cancer type. Exclusion Criteria: * None.
References
Publications (2)
- BACKGROUNDRamsey LB, Balis FM, O'Brien MM, Schmiegelow K, Pauley JL, Bleyer A, Widemann BC, Askenazi D, Bergeron S, Shirali A, Schwartz S, Vinks AA, Heldrup J. Consensus Guideline for Use of Glucarpidase in Patients with High-Dose Methotrexate Induced Acute Kidney Injury and Delayed Methotrexate Clearance. Oncologist. 2018 Jan;23(1):52-61. doi: 10.1634/theoncologist.2017-0243. Epub 2017 Oct 27. PMID 29079637
- BACKGROUNDTaylor ZL, Mizuno T, Punt NC, Baskaran B, Navarro Sainz A, Shuman W, Felicelli N, Vinks AA, Heldrup J, Ramsey LB. MTXPK.org: A Clinical Decision Support Tool Evaluating High-Dose Methotrexate Pharmacokinetics to Inform Post-Infusion Care and Use of Glucarpidase. Clin Pharmacol Ther. 2020 Sep;108(3):635-643. doi: 10.1002/cpt.1957. Epub 2020 Jul 18. PMID 32558929