Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-27 @ 5:43 AM
Study NCT ID:
NCT03719560
Status:
WITHDRAWN
Last Update Posted:
2020-04-13
First Post:
2018-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Systemic Central Nervous System Prophylaxis in Diffuse Large B-cell Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}], 'ancestors': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'D003561', 'term': 'Cytarabine'}], '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'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D001087', 'term': 'Arabinonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'lack of funding', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-10', 'studyFirstSubmitDate': '2018-10-23', 'studyFirstSubmitQcDate': '2018-10-23', 'lastUpdatePostDateStruct': {'date': '2020-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion with clinically significant toxicity', 'timeFrame': '1 year', 'description': 'Clinically significant toxicity as defined in the protocol'}], 'secondaryOutcomes': [{'measure': 'Cumulative incidence of central nervous system recurrence', 'timeFrame': '2 years', 'description': 'Cumulative incidence of central nervous system recurrence'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diffuse Large B Cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'Phase 2 single-institution trial of early systemic central nervous system prophylaxis in high-risk diffuse large B-cell lymphoma', 'detailedDescription': 'This is a prospective phase 2 clinical trial of systemic central nervous system prophylaxis among patients with diffuse large B-cell lymphoma at high risk of central nervous system recurrence. The main objective is to evaluate safety and efficacy of early institution of intensive central nervous system prophylaxis in a high-risk group to minimize the risk of a devastating central nervous system recurrence. Patients receive standard primary immunochemotherapy with an addition of planned central nervous system prophylaxis courses on or around day 15 of cycles 2, 4, and 6. Growth factor support and Pneumocystis jirovecii prophylaxis is required. The primary endpoint of this pilot study is protocol-defined toxicity, whereas efficacy (cumulative incidence of central nervous system recurrence) will be a secondary endpoint.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* New diagnosis of diffuse large B-cell lymphoma, planned first-line therapy using the standard rituximab- and anthracycline-containing regimens\n* No central nervous system involvement on initial staging\n* Performance status of 0 or 1 (Eastern Cooperative Oncology Group scale)\n* Renal function: creatinine clearance \\>45 ml/min\n* Not pregnant; agreeable to contraception\n* Written informed consent\n* High risk for central nervous system recurrence as determined by one of the following high-risk features:\n\n 1. high central nervous system International Prognostic Index,\n 2. testicular, breast, or uterine involvement,\n 3. dual expresser or double/triple-hit status,\n 4. HIV positive status, or\n 5. Molecularly defined high-risk subtype.\n\nExclusion Criteria:\n\n* pregancy\n* unable to provide informed consent\n* significant comorbidity in the investigator's judgement"}, 'identificationModule': {'nctId': 'NCT03719560', 'acronym': 'BrUOG-377', 'briefTitle': 'Early Systemic Central Nervous System Prophylaxis in Diffuse Large B-cell Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Brown University'}, 'officialTitle': 'Early Systemic Central Nervous System Prophylaxis in Diffuse Large B-cell Lymphoma', 'orgStudyIdInfo': {'id': 'BrUOG-377'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CNS prophylaxis protocol', 'description': 'Patients will receive central nervous system prophylaxis protocol using high-dose methotrexate and cytarabine.', 'interventionNames': ['Drug: Methotrexate', 'Drug: Cytarabine']}], 'interventions': [{'name': 'Methotrexate', 'type': 'DRUG', 'otherNames': ['Methotrexate sodium'], 'description': 'Systemic methotrexate', 'armGroupLabels': ['CNS prophylaxis protocol']}, {'name': 'Cytarabine', 'type': 'DRUG', 'otherNames': ['Cytosar-U'], 'description': 'Systemic cytarabine', 'armGroupLabels': ['CNS prophylaxis protocol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Roxanne Wood', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'overallOfficials': [{'name': 'Adam J Olszewski, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rhode Island Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brown University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}