Trial Title:
Retrospective Registry Study of Patients With Cancer Treated With High-dose Methotrexate
NCT ID:
NCT05899751
Condition:
Acute Kidney Injury
Drug Toxicity
Conditions: Official terms:
Acute Kidney Injury
Drug-Related Side Effects and Adverse Reactions
Methotrexate
Conditions: Keywords:
Carboxypeptidases
Delayed Methotrexate Clearance
Hematologic Neoplasms
Hyperhydration
Leucovorin
Osteosarcoma
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Drug
Intervention name:
High-dose methotrexate
Description:
High-dose methotrexate
Arm group label:
Patients Treated With High-dose Methotrexate
Intervention type:
Drug
Intervention name:
Glucarpidase
Description:
Glucarpidase
Arm group label:
Patients Treated With High-dose Methotrexate
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.
Criteria for eligibility:
Study pop:
The study will be conducted at approximately 10 European sites where high-dose
methotrexate infusions are administered. Sites will be selected to ensure a balanced
accrual of children and adults treated with high-dose methotrexate.
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Assistance Publique Hôpitaux de Marseille (APHM), La Timone Hospital
Address:
City:
Marseille
Zip:
13354
Country:
France
Status:
Recruiting
Contact:
Last name:
Jennifer Lowe
Phone:
+1 (214) 924 2117
Email:
jennifer.lowe@resonancehealth.org
Contact backup:
Last name:
Buck Cansino
Phone:
12109319433
Email:
buck.cansino@resonancehealth.org
Facility:
Name:
University of Milan-Bicocca
Address:
City:
Monza
Zip:
20900
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Jennifer Lowe
Phone:
+1 (214) 924 2117
Email:
jennifer.lowe@resonancehealth.org
Contact backup:
Last name:
Buck Cansino
Phone:
12109319433
Email:
buck.cansino@resonancehealth.org
Facility:
Name:
Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Jennifer Lowe
Phone:
+1 (214) 924 2117
Email:
jennifer.lowe@resonancehealth.org
Contact backup:
Last name:
Buck Cansino
Phone:
+1 (210) 931-9433
Email:
buck.cansino@resonancehealth.org
Facility:
Name:
Fundación Privada Instituto de Investigación Oncológica de Vall d'Hebron (VHIO)
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Jennifer Lowe
Phone:
+1 (214) 924 2117
Email:
jennifer.lowe@resonancehealth.org
Contact backup:
Last name:
Buck Cansino
Phone:
12109319433
Email:
buck.cansino@resonancehealth.org
Facility:
Name:
Hospital Universitario Reina Sofía
Address:
City:
Córdoba
Zip:
14004
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Jennifer Lowe
Phone:
+1 (214) 924 2117
Email:
jennifer.lowe@resonancehealth.org
Contact backup:
Last name:
Buck Cansino
Phone:
12109319433
Email:
buck.cansino@resonancehealth.org
Start date:
April 1, 2022
Completion date:
December 2024
Lead sponsor:
Agency:
Protherics Medicines Development Limited
Agency class:
Other
Collaborator:
Agency:
Resonance Health
Agency class:
Industry
Source:
BTG International Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05899751
http://MTXPK.org
https://www.ema.europa.eu/en/documents/product-information/voraxaze-epar-product-information_en.pdf
