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

May 9, 2024 updated by: Protherics Medicines Development Limited

High-dose Methotrexate Patterns of Use, Clearance, Toxicities, Supportive Care and Outcomes

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patients Treated With High-dose Methotrexate
Patients with a diagnosis of any cancer receiving high-dose methotrexate chemotherapy.
Drug: High-dose methotrexate
High-dose methotrexate
Drug: Glucarpidase
Glucarpidase

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Delayed Elimination of Methotrexate
Time Frame: 0-48 hours from the start of high-dose methotrexate infusion.
Incidence of delayed elimination of methotrexate after high-dose methotrexate chemotherapy, defined by Ramsey criteria.
0-48 hours from the start of high-dose methotrexate infusion.
Acute Kidney Injury
Time Frame: 0-48 hours from the start of high-dose methotrexate infusion.
Incidence of acute kidney injury of any grade after high-dose methotrexate chemotherapy.
0-48 hours from the start of high-dose methotrexate infusion.
Severe Delayed Elimination of Methotrexate
Time Frame: 0-48 hours from the start of high-dose methotrexate infusion.
Incidence of severe delayed elimination of methotrexate after high-dose methotrexate chemotherapy, defined as a methotrexate level ≥2 standard deviations above the population mean at 36, 42, or 48 hours from the start of high-dose methotrexate infusion and with the presence of acute kidney injury of any grade.
0-48 hours from the start of high-dose methotrexate infusion.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Severity of Acute Kidney Injury
Time Frame: 0-48 hours from the start of high-dose methotrexate infusion.
Severity of occurrences of acute kidney injury using CTCAE v5 criteria.
0-48 hours from the start of high-dose methotrexate infusion.
Hospital Length of Stay
Time Frame: Assessed through study completion, up to 2 years after enrollment.
Duration of hospitalization.
Assessed through study completion, up to 2 years after enrollment.
Hospital Readmission
Time Frame: Within 14 days of high-dose methotrexate infusion.
Incidence of hospital readmission.
Within 14 days of high-dose methotrexate infusion.
Delay of Subsequent Chemotherapy
Time Frame: Within 14 days of high-dose methotrexate infusion.
Occurrence of delays to further blocks of chemotherapy resulting from delayed methotrexate elimination.
Within 14 days of high-dose methotrexate infusion.
Dose Reduction or Omission of Subsequent High-dose Methotrexate Therapy
Time Frame: Within 14 days of high-dose methotrexate infusion.
Occurrence of dose reduction or omission of high-dose methotrexate from further cycles of chemotherapy resulting from delayed methotrexate elimination.
Within 14 days of high-dose methotrexate infusion.
Event-Free Survival
Time Frame: 3, 5, and 10 years.
"Events" include death, relapse, abandonment, or refusal of treatment.
3, 5, and 10 years.
Overall Survival
Time Frame: 3, 5, and 10 years.
All-cause mortality as well as mortality separately due to disease progression or toxicity.
3, 5, and 10 years.
Glucarpidase-Related Toxicity
Time Frame: 15 minutes post-glucarpidase through discharge.
Occurrence of toxicities associated with glucarpidase, including frequency, severity (using CTCAE v5 criteria) and including documenting any toxicities of grade 3 or higher.
15 minutes post-glucarpidase through discharge.
Methotrexate Clearance after Glucarpidase
Time Frame: 15 minutes post-glucarpidase through discharge.
MTX levels.
15 minutes post-glucarpidase through discharge.
Serum Creatinine Level
Time Frame: 15 minutes post-glucarpidase through discharge.
Renal function, as measured by serum creatinine level.
15 minutes post-glucarpidase through discharge.
Use of Subsequent High-Dose Methotrexate After Glucarpidase
Time Frame: Within 14 days of high-dose methotrexate infusion.
Occurrence of subsequent high-dose methotrexate chemotherapy cycles given after glucarpidase.
Within 14 days of high-dose methotrexate infusion.
Disease Outcome After Glucarpidase
Time Frame: 3, 5, and 10 years.
Disease outcome after glucarpidase
3, 5, and 10 years.
Use of Hyperhydration
Time Frame: Assessed at time of hospital discharge.
Incidence of the use of hyperhydration supportive care measures during high-dose methotrexate chemotherapy.
Assessed at time of hospital discharge.
Use of Leucovorin
Time Frame: Assessed at time of hospital discharge.
Incidence of the use of leucovorin during high-dose methotrexate chemotherapy.
Assessed at time of hospital discharge.
Use of Dialysis or Hemofiltration
Time Frame: Assessed at time of hospital discharge.
Incidence of the use of dialysis or hemofiltration during high-dose methotrexate chemotherapy.
Assessed at time of hospital discharge.
Use of Oral Methotrexate Binders
Time Frame: Assessed at time of hospital discharge.
Incidence of the use of oral methotrexate binders (cholestyramine, activated charcoal) during high-dose methotrexate chemotherapy.
Assessed at time of hospital discharge.
Creatinine Clearance
Time Frame: 15 minutes post-glucarpidase through discharge.
Renal function, as measured by creatinine estimate
15 minutes post-glucarpidase through discharge.
Need for Dialysis
Time Frame: 15 minutes post-glucarpidase through discharge.
Renal function, as measured by need for dialysis.
15 minutes post-glucarpidase through discharge.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Protherics Medicines Development Limited

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Resonance Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Carmelo Rizzari, MD, University of Milano-Bicocca, Pediatric Hematology Oncology Unit MBBM Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 11, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 10, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PR001-CLN-pro101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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