NCT05899751

Retrospective Registry Study of Patients With Cancer Treated With High-dose Methotrexate

High-dose Methotrexate Patterns of Use, Clearance, Toxicities, Supportive Care and Outcomes

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Protherics Medicines Development Limited · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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

• Acute Kidney Injury
• Drug Toxicity

Interventions

Type	Name	Description
DRUG	High-dose methotrexate	High-dose methotrexate
DRUG	Glucarpidase	Glucarpidase

Timeline

• Start date: 2022-04-01
• Primary completion: 2024-08-01
• Completion: 2024-12-01
• First posted: 2023-06-12
• Last updated: 2024-05-10

Locations

5 sites across 3 countries: France, Italy, Spain