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

NCT05899751 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2024-05-10

No results posted yet for this study

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

Interventions

DRUG

High-dose methotrexate

High-dose methotrexate

DRUG

Glucarpidase

Glucarpidase

Sponsors & Collaborators

  • Resonance Health

    collaborator INDUSTRY

  • Protherics Medicines Development Limited

    lead OTHER

Principal Investigators

  • Carmelo Rizzari, MD · University of Milano-Bicocca, Pediatric Hematology Oncology Unit MBBM Foundation

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2024-08-31
Completion
2024-12-31

Countries

  • France
  • Italy
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05899751 on ClinicalTrials.gov