Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:50 PM
Study NCT ID:
NCT05899751
Status:
UNKNOWN
Last Update Posted:
2024-05-10
First Post:
2023-04-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Retrospective Registry Study of Patients With Cancer Treated With High-dose Methotrexate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D014869', 'term': 'Water Intoxication'}, {'id': 'D012516', 'term': 'Osteosarcoma'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D011041', 'term': 'Poisoning'}, {'id': 'D018213', 'term': 'Neoplasms, Bone Tissue'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D012509', 'term': 'Sarcoma'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'C000629556', 'term': 'glucarpidase'}], 'ancestors': [{'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-09', 'studyFirstSubmitDate': '2023-04-11', 'studyFirstSubmitQcDate': '2023-06-09', 'lastUpdatePostDateStruct': {'date': '2024-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Delayed Elimination of Methotrexate', 'timeFrame': '0-48 hours from the start of high-dose methotrexate infusion.', 'description': 'Incidence of delayed elimination of methotrexate after high-dose methotrexate chemotherapy, defined by Ramsey criteria.'}, {'measure': 'Acute Kidney Injury', 'timeFrame': '0-48 hours from the start of high-dose methotrexate infusion.', 'description': 'Incidence of acute kidney injury of any grade after high-dose methotrexate chemotherapy.'}, {'measure': 'Severe Delayed Elimination of Methotrexate', 'timeFrame': '0-48 hours from the start of high-dose methotrexate infusion.', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Severity of Acute Kidney Injury', 'timeFrame': '0-48 hours from the start of high-dose methotrexate infusion.', 'description': 'Severity of occurrences of acute kidney injury using CTCAE v5 criteria.'}, {'measure': 'Hospital Length of Stay', 'timeFrame': 'Assessed through study completion, up to 2 years after enrollment.', 'description': 'Duration of hospitalization.'}, {'measure': 'Hospital Readmission', 'timeFrame': 'Within 14 days of high-dose methotrexate infusion.', 'description': 'Incidence of hospital readmission.'}, {'measure': 'Delay of Subsequent Chemotherapy', 'timeFrame': 'Within 14 days of high-dose methotrexate infusion.', 'description': 'Occurrence of delays to further blocks of chemotherapy resulting from delayed methotrexate elimination.'}, {'measure': 'Dose Reduction or Omission of Subsequent High-dose Methotrexate Therapy', 'timeFrame': 'Within 14 days of high-dose methotrexate infusion.', 'description': 'Occurrence of dose reduction or omission of high-dose methotrexate from further cycles of chemotherapy resulting from delayed methotrexate elimination.'}, {'measure': 'Event-Free Survival', 'timeFrame': '3, 5, and 10 years.', 'description': '"Events" include death, relapse, abandonment, or refusal of treatment.'}, {'measure': 'Overall Survival', 'timeFrame': '3, 5, and 10 years.', 'description': 'All-cause mortality as well as mortality separately due to disease progression or toxicity.'}, {'measure': 'Glucarpidase-Related Toxicity', 'timeFrame': '15 minutes post-glucarpidase through discharge.', 'description': 'Occurrence of toxicities associated with glucarpidase, including frequency, severity (using CTCAE v5 criteria) and including documenting any toxicities of grade 3 or higher.'}, {'measure': 'Methotrexate Clearance after Glucarpidase', 'timeFrame': '15 minutes post-glucarpidase through discharge.', 'description': 'MTX levels.'}, {'measure': 'Serum Creatinine Level', 'timeFrame': '15 minutes post-glucarpidase through discharge.', 'description': 'Renal function, as measured by serum creatinine level.'}, {'measure': 'Use of Subsequent High-Dose Methotrexate After Glucarpidase', 'timeFrame': 'Within 14 days of high-dose methotrexate infusion.', 'description': 'Occurrence of subsequent high-dose methotrexate chemotherapy cycles given after glucarpidase.'}, {'measure': 'Disease Outcome After Glucarpidase', 'timeFrame': '3, 5, and 10 years.', 'description': 'Disease outcome after glucarpidase'}, {'measure': 'Use of Hyperhydration', 'timeFrame': 'Assessed at time of hospital discharge.', 'description': 'Incidence of the use of hyperhydration supportive care measures during high-dose methotrexate chemotherapy.'}, {'measure': 'Use of Leucovorin', 'timeFrame': 'Assessed at time of hospital discharge.', 'description': 'Incidence of the use of leucovorin during high-dose methotrexate chemotherapy.'}, {'measure': 'Use of Dialysis or Hemofiltration', 'timeFrame': 'Assessed at time of hospital discharge.', 'description': 'Incidence of the use of dialysis or hemofiltration during high-dose methotrexate chemotherapy.'}, {'measure': 'Use of Oral Methotrexate Binders', 'timeFrame': 'Assessed at time of hospital discharge.', 'description': 'Incidence of the use of oral methotrexate binders (cholestyramine, activated charcoal) during high-dose methotrexate chemotherapy.'}, {'measure': 'Creatinine Clearance', 'timeFrame': '15 minutes post-glucarpidase through discharge.', 'description': 'Renal function, as measured by creatinine estimate'}, {'measure': 'Need for Dialysis', 'timeFrame': '15 minutes post-glucarpidase through discharge.', 'description': 'Renal function, as measured by need for dialysis.'}]}, 'conditionsModule': {'keywords': ['Carboxypeptidases', 'Delayed Methotrexate Clearance', 'Hematologic Neoplasms', 'Hyperhydration', 'Leucovorin', 'Osteosarcoma'], 'conditions': ['Acute Kidney Injury', 'Drug Toxicity']}, 'referencesModule': {'references': [{'pmid': '29079637', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '32558929', 'type': 'BACKGROUND', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://MTXPK.org', 'label': 'A pharmacokinetic model for the dose of methotrexate to display the concentration vs time curve for an individual patient overlaid upon the population-predicted curve for that dose.'}, {'url': 'https://www.ema.europa.eu/en/documents/product-information/voraxaze-epar-product-information_en.pdf', 'label': 'Voraxaze Summary of Product Characteristics (SmPC)'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A diagnosis of any cancer from January 1, 2001 to June 30, 2021.\n* Receipt of high-dose methotrexate chemotherapy, defined as a dose of 500 mg/m2 of body surface area or higher.\n* Medical records available for review.\n* Any age; any cancer type.\n\nExclusion Criteria:\n\n* None.'}, 'identificationModule': {'nctId': 'NCT05899751', 'briefTitle': 'Retrospective Registry Study of Patients With Cancer Treated With High-dose Methotrexate', 'organization': {'class': 'OTHER', 'fullName': 'BTG International Inc.'}, 'officialTitle': 'High-dose Methotrexate Patterns of Use, Clearance, Toxicities, Supportive Care and Outcomes', 'orgStudyIdInfo': {'id': 'PR001-CLN-pro101'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients Treated With High-dose Methotrexate', 'description': 'Patients with a diagnosis of any cancer receiving high-dose methotrexate chemotherapy.', 'interventionNames': ['Drug: High-dose methotrexate', 'Drug: Glucarpidase']}], 'interventions': [{'name': 'High-dose methotrexate', 'type': 'DRUG', 'description': 'High-dose methotrexate', 'armGroupLabels': ['Patients Treated With High-dose Methotrexate']}, {'name': 'Glucarpidase', 'type': 'DRUG', 'description': 'Glucarpidase', 'armGroupLabels': ['Patients Treated With High-dose Methotrexate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13354', 'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jennifer Lowe', 'role': 'CONTACT', 'email': 'jennifer.lowe@resonancehealth.org', 'phone': '+1 (214) 924 2117'}, {'name': 'Buck Cansino', 'role': 'CONTACT', 'email': 'buck.cansino@resonancehealth.org', 'phone': '12109319433'}], 'facility': 'Assistance Publique Hôpitaux de Marseille (APHM), La Timone Hospital', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '20900', 'city': 'Monza', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Jennifer Lowe', 'role': 'CONTACT', 'email': 'jennifer.lowe@resonancehealth.org', 'phone': '+1 (214) 924 2117'}, {'name': 'Buck Cansino', 'role': 'CONTACT', 'email': 'buck.cansino@resonancehealth.org', 'phone': '12109319433'}], 'facility': 'University of Milan-Bicocca', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}, {'zip': '08035', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Jennifer Lowe', 'role': 'CONTACT', 'email': 'jennifer.lowe@resonancehealth.org', 'phone': '+1 (214) 924 2117'}, {'name': 'Buck Cansino', 'role': 'CONTACT', 'email': 'buck.cansino@resonancehealth.org', 'phone': '+1 (210) 931-9433'}], 'facility': "Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08035', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Jennifer Lowe', 'role': 'CONTACT', 'email': 'jennifer.lowe@resonancehealth.org', 'phone': '+1 (214) 924 2117'}, {'name': 'Buck Cansino', 'role': 'CONTACT', 'email': 'buck.cansino@resonancehealth.org', 'phone': '12109319433'}], 'facility': "Fundación Privada Instituto de Investigación Oncológica de Vall d'Hebron (VHIO)", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '14004', 'city': 'Córdoba', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Jennifer Lowe', 'role': 'CONTACT', 'email': 'jennifer.lowe@resonancehealth.org', 'phone': '+1 (214) 924 2117'}, {'name': 'Buck Cansino', 'role': 'CONTACT', 'email': 'buck.cansino@resonancehealth.org', 'phone': '12109319433'}], 'facility': 'Hospital Universitario Reina Sofía', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}], 'centralContacts': [{'name': 'Lois Wallace', 'role': 'CONTACT', 'email': 'Lois.wallace@btgsp.com', 'phone': '+1 945 239 1690'}, {'name': 'Jennie Molland', 'role': 'CONTACT', 'email': 'Jennie.molland@btgsp.com', 'phone': '+44 1239 851122'}], 'overallOfficials': [{'name': 'Carmelo Rizzari, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Milano-Bicocca, Pediatric Hematology Oncology Unit MBBM Foundation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Protherics Medicines Development Limited', 'class': 'OTHER'}, 'collaborators': [{'name': 'Resonance Health', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}