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

Last updated: May 9, 2024
Sponsor: Protherics Medicines Development Limited
Overall Status: Active - Recruiting

Phase

N/A

Condition

Kidney Failure

Renal Failure

Kidney Disease

Treatment

Glucarpidase

High-dose methotrexate

Clinical Study ID

NCT05899751
PR001-CLN-pro101
  • All Genders

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.

Eligibility Criteria

Inclusion

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 bodysurface area or higher.
  • Medical records available for review.
  • Any age; any cancer type.

Exclusion

Exclusion Criteria:

  • None.

Study Design

Total Participants: 1000
Treatment Group(s): 2
Primary Treatment: Glucarpidase
Phase:
Study Start date:
April 01, 2022
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Assistance Publique Hôpitaux de Marseille (APHM), La Timone Hospital

    Marseille, 13354
    France

    Active - Recruiting

  • University of Milan-Bicocca

    Monza, 20900
    Italy

    Active - Recruiting

  • Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Fundación Privada Instituto de Investigación Oncológica de Vall d'Hebron (VHIO)

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital Universitario Reina Sofía

    Córdoba, 14004
    Spain

    Active - Recruiting

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