Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-03-26 @ 5:18 PM
Study NCT ID:
NCT02836158
Status:
RECRUITING
Last Update Posted:
2020-09-09
First Post:
2016-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Therapeutic Effects of R-IDARAM and Intrathecal Immunochemotherapy on Elderly Patients With PCNSL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-08', 'studyFirstSubmitDate': '2016-07-14', 'studyFirstSubmitQcDate': '2016-07-14', 'lastUpdatePostDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '3 year Overall survival', 'description': '3 year Overall survival'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Primary Central Nervous System Lymphoma']}, 'descriptionModule': {'briefSummary': 'This study suggests that R-IDARAM combined with intrathecal immunochemotherapy may be high effective in elderly patients with primary central nervous system lymphoma (PCNSL).', 'detailedDescription': 'The investigators will evaluate response rate, progression free survival (PFS), overall survival (OS), and toxicity in elderly patients with primary central nervous system lymphoma (PCNSL) after systemic and intrathecal immunochemotherapy with deferred radiotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Newly diagnosed histologically proven non-Hodgkin's lymphoma (NHL).\n\nExclusion Criteria:\n\n* Involved sites other than the brain, meninges, CSF, or the eyes.\n* Age less than 18 years or greater than 75 years.\n* Inadequate bone marrow capacity (defined as neutrophils\\<1.5 ×10\\^9/L, platelets \\<100 ×10\\^9/L, and hemoglobin level\\< 8 g/dL).\n* Known cause of immunosuppression (ie, HIV type I infection).\n* Any previous malignancy.\n* Creatinine clearance below 60 mL/min.\n* Heart insufficiency (NYHA IIIB or IV).\n* Uncontrolled infection.\n* Noncompensated active pulmonary or liver disease.\n* Previously treated for PCNSL, except by corticosteroids."}, 'identificationModule': {'nctId': 'NCT02836158', 'briefTitle': 'Therapeutic Effects of R-IDARAM and Intrathecal Immunochemotherapy on Elderly Patients With PCNSL', 'organization': {'class': 'OTHER', 'fullName': 'Navy General Hospital, Beijing'}, 'officialTitle': 'Therapeutic Effects of R-IDARAM and Intrathecal Immunochemotherapy on Elderly Patients With Primary CNS Lymphoma', 'orgStudyIdInfo': {'id': 'NavyGHB-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'R-IDARAM plus intrathecal chemotherapy', 'description': 'Patients will be treated with systemic R-IDARAM plus intrathecal immunochemotherapy', 'interventionNames': ['Drug: R-IDARAM plus intrathecal chemotherapy']}], 'interventions': [{'name': 'R-IDARAM plus intrathecal chemotherapy', 'type': 'DRUG', 'otherNames': ['R-IDARAM plus intrathecal immuochemotherapy'], 'description': 'R-IDARAM comprised of rituximab 375 mg/m2 (day 1), idarubicin 10 mg/m2(day 2); dexamethasone 100 mg/m2 (12 h.infusion in day 2, 3 and 4); cytarabine 1 g/m2 (1 h. infusion in day 2); methotrexate 1.5 g/m2 (6 h. infusion in day 4 with folinic acid rescue). Intrathecal Immunochemotherapy comprised of rituximab 20mg, MTX 15mg, dexamethasone 5mg and Ara-c 50mg once a week.', 'armGroupLabels': ['R-IDARAM plus intrathecal chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100048', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Liren Qian, M.D.', 'role': 'CONTACT', 'email': 'qlr2007@126.com', 'phone': '+861066957676'}], 'facility': 'Navy General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Liren Qian, M.D.', 'role': 'CONTACT', 'email': 'qlr2007@126.com', 'phone': '+861066957676'}], 'overallOfficials': [{'name': 'Liren Qian, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Navy General Hospital, Beijing'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Navy General Hospital, Beijing', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Liren Qian', 'investigatorAffiliation': 'Navy General Hospital, Beijing'}}}}