- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05899751
Retrospective Registry Study of Patients With Cancer Treated With High-dose Methotrexate
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Lois Wallace
- Phone Number: +1 945 239 1690
- Email: Lois.wallace@btgsp.com
Study Contact Backup
- Name: Jennie Molland
- Phone Number: +44 1239 851122
- Email: Jennie.molland@btgsp.com
Study Locations
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Marseille, France, 13354
- Recruiting
- Assistance Publique Hôpitaux de Marseille (APHM), La Timone Hospital
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Contact:
- Jennifer Lowe
- Phone Number: +1 (214) 924 2117
- Email: jennifer.lowe@resonancehealth.org
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Contact:
- Buck Cansino
- Phone Number: 12109319433
- Email: buck.cansino@resonancehealth.org
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Monza, Italy, 20900
- Recruiting
- University of Milan-Bicocca
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Contact:
- Jennifer Lowe
- Phone Number: +1 (214) 924 2117
- Email: jennifer.lowe@resonancehealth.org
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Contact:
- Buck Cansino
- Phone Number: 12109319433
- Email: buck.cansino@resonancehealth.org
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Barcelona, Spain, 08035
- Recruiting
- Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)
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Contact:
- Jennifer Lowe
- Phone Number: +1 (214) 924 2117
- Email: jennifer.lowe@resonancehealth.org
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Contact:
- Buck Cansino
- Phone Number: +1 (210) 931-9433
- Email: buck.cansino@resonancehealth.org
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Barcelona, Spain, 08035
- Recruiting
- Fundación Privada Instituto de Investigación Oncológica de Vall d'Hebron (VHIO)
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Contact:
- Jennifer Lowe
- Phone Number: +1 (214) 924 2117
- Email: jennifer.lowe@resonancehealth.org
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Contact:
- Buck Cansino
- Phone Number: 12109319433
- Email: buck.cansino@resonancehealth.org
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Córdoba, Spain, 14004
- Recruiting
- Hospital Universitario Reina Sofia
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Contact:
- Jennifer Lowe
- Phone Number: +1 (214) 924 2117
- Email: jennifer.lowe@resonancehealth.org
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Contact:
- Buck Cansino
- Phone Number: 12109319433
- Email: buck.cansino@resonancehealth.org
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients Treated With High-dose Methotrexate
Patients with a diagnosis of any cancer receiving high-dose methotrexate chemotherapy.
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High-dose methotrexate
Glucarpidase
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Delayed Elimination of Methotrexate
Time Frame: 0-48 hours from the start of high-dose methotrexate infusion.
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Incidence of delayed elimination of methotrexate after high-dose methotrexate chemotherapy, defined by Ramsey criteria.
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0-48 hours from the start of high-dose methotrexate infusion.
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Acute Kidney Injury
Time Frame: 0-48 hours from the start of high-dose methotrexate infusion.
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Incidence of acute kidney injury of any grade after high-dose methotrexate chemotherapy.
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0-48 hours from the start of high-dose methotrexate infusion.
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Severe Delayed Elimination of Methotrexate
Time Frame: 0-48 hours from the start of high-dose methotrexate infusion.
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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.
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0-48 hours from the start of high-dose methotrexate infusion.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Severity of Acute Kidney Injury
Time Frame: 0-48 hours from the start of high-dose methotrexate infusion.
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Severity of occurrences of acute kidney injury using CTCAE v5 criteria.
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0-48 hours from the start of high-dose methotrexate infusion.
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Hospital Length of Stay
Time Frame: Assessed through study completion, up to 2 years after enrollment.
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Duration of hospitalization.
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Assessed through study completion, up to 2 years after enrollment.
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Hospital Readmission
Time Frame: Within 14 days of high-dose methotrexate infusion.
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Incidence of hospital readmission.
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Within 14 days of high-dose methotrexate infusion.
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Delay of Subsequent Chemotherapy
Time Frame: Within 14 days of high-dose methotrexate infusion.
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Occurrence of delays to further blocks of chemotherapy resulting from delayed methotrexate elimination.
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Within 14 days of high-dose methotrexate infusion.
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Dose Reduction or Omission of Subsequent High-dose Methotrexate Therapy
Time Frame: Within 14 days of high-dose methotrexate infusion.
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Occurrence of dose reduction or omission of high-dose methotrexate from further cycles of chemotherapy resulting from delayed methotrexate elimination.
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Within 14 days of high-dose methotrexate infusion.
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Event-Free Survival
Time Frame: 3, 5, and 10 years.
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"Events" include death, relapse, abandonment, or refusal of treatment.
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3, 5, and 10 years.
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Overall Survival
Time Frame: 3, 5, and 10 years.
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All-cause mortality as well as mortality separately due to disease progression or toxicity.
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3, 5, and 10 years.
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Glucarpidase-Related Toxicity
Time Frame: 15 minutes post-glucarpidase through discharge.
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Occurrence of toxicities associated with glucarpidase, including frequency, severity (using CTCAE v5 criteria) and including documenting any toxicities of grade 3 or higher.
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15 minutes post-glucarpidase through discharge.
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Methotrexate Clearance after Glucarpidase
Time Frame: 15 minutes post-glucarpidase through discharge.
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MTX levels.
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15 minutes post-glucarpidase through discharge.
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Serum Creatinine Level
Time Frame: 15 minutes post-glucarpidase through discharge.
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Renal function, as measured by serum creatinine level.
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15 minutes post-glucarpidase through discharge.
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Use of Subsequent High-Dose Methotrexate After Glucarpidase
Time Frame: Within 14 days of high-dose methotrexate infusion.
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Occurrence of subsequent high-dose methotrexate chemotherapy cycles given after glucarpidase.
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Within 14 days of high-dose methotrexate infusion.
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Disease Outcome After Glucarpidase
Time Frame: 3, 5, and 10 years.
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Disease outcome after glucarpidase
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3, 5, and 10 years.
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Use of Hyperhydration
Time Frame: Assessed at time of hospital discharge.
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Incidence of the use of hyperhydration supportive care measures during high-dose methotrexate chemotherapy.
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Assessed at time of hospital discharge.
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Use of Leucovorin
Time Frame: Assessed at time of hospital discharge.
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Incidence of the use of leucovorin during high-dose methotrexate chemotherapy.
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Assessed at time of hospital discharge.
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Use of Dialysis or Hemofiltration
Time Frame: Assessed at time of hospital discharge.
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Incidence of the use of dialysis or hemofiltration during high-dose methotrexate chemotherapy.
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Assessed at time of hospital discharge.
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Use of Oral Methotrexate Binders
Time Frame: Assessed at time of hospital discharge.
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Incidence of the use of oral methotrexate binders (cholestyramine, activated charcoal) during high-dose methotrexate chemotherapy.
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Assessed at time of hospital discharge.
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Creatinine Clearance
Time Frame: 15 minutes post-glucarpidase through discharge.
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Renal function, as measured by creatinine estimate
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15 minutes post-glucarpidase through discharge.
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Need for Dialysis
Time Frame: 15 minutes post-glucarpidase through discharge.
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Renal function, as measured by need for dialysis.
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15 minutes post-glucarpidase through discharge.
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Carmelo Rizzari, MD, University of Milano-Bicocca, Pediatric Hematology Oncology Unit MBBM Foundation
Publications and helpful links
General Publications
- Ramsey LB, Balis FM, O'Brien MM, Schmiegelow K, Pauley JL, Bleyer A, Widemann BC, Askenazi D, Bergeron S, Shirali A, Schwartz S, Vinks AA, Heldrup J. Consensus Guideline for Use of Glucarpidase in Patients with High-Dose Methotrexate Induced Acute Kidney Injury and Delayed Methotrexate Clearance. Oncologist. 2018 Jan;23(1):52-61. doi: 10.1634/theoncologist.2017-0243. Epub 2017 Oct 27.
- Taylor ZL, Mizuno T, Punt NC, Baskaran B, Navarro Sainz A, Shuman W, Felicelli N, Vinks AA, Heldrup J, Ramsey LB. MTXPK.org: A Clinical Decision Support Tool Evaluating High-Dose Methotrexate Pharmacokinetics to Inform Post-Infusion Care and Use of Glucarpidase. Clin Pharmacol Ther. 2020 Sep;108(3):635-643. doi: 10.1002/cpt.1957. Epub 2020 Jul 18.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Chemically-Induced Disorders
- Kidney Diseases
- Urologic Diseases
- Renal Insufficiency
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Acute Kidney Injury
- Drug-Related Side Effects and Adverse Reactions
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Dermatologic Agents
- Reproductive Control Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Methotrexate
Other Study ID 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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