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

Protherics Medicines Development Limited

Status

Enrolling

Conditions

Acute Kidney Injury

Drug Toxicity

Treatments

Drug: Glucarpidase

Drug: High-dose methotrexate

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT05899751

PR001-CLN-pro101

Details and patient eligibility

About

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.

Enrollment

1,000 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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