Retrospective Registry Study of Patients With Cancer Treated With High-dose Methotrexate
Sponsored by Protherics Medicines Development Limited
About this trial
Last updated 2 years ago
Study ID
PR001-CLN-pro101
Status
Recruiting
Type
Observational
Placebo
No
Accepting
All
All
Not accepting
Healthy Volunteers
Trial Timing
Ended 2 years ago
What is this trial 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.
What are the participation requirements?
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.
Locations
Location
Status
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting