Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2026-01-04 @ 7:16 PM
Study NCT ID:
NCT00210366
Status:
TERMINATED
Last Update Posted:
2010-07-30
First Post:
2005-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Salvage Therapy With Idarubicin in Relapsing CNS Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}], 'ancestors': [{'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': 'D015255', 'term': 'Idarubicin'}], 'ancestors': [{'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'whyStopped': 'due to slow accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'lastUpdateSubmitDate': '2010-07-29', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2010-07-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'objective response to treatment'}], 'secondaryOutcomes': [{'measure': 'duration of response'}, {'measure': 'overall survival'}, {'measure': 'acute side effects of idarubicin'}]}, 'conditionsModule': {'conditions': ['Lymphoma, B-Cell']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ielsg.org', 'label': 'Click here for more information about this study'}]}, 'descriptionModule': {'briefSummary': 'The main objective of the trial is to assess the therapeutic activity of idarubicin as salvage treatment in patients with recurrent or progressive lymphoma in the central nervous system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histological or cytological diagnosis of non-Hodgkin's lymphoma\n* Disease exclusively localised into the CNS at first diagnosis and failure\n* Progressive or recurrent disease\n* Previous treatment with HDMTX containing CHT and/or RT\n* Presence of at least one target lesion, bidimensionally measurable\n* Age 18 - 75 years\n* ECOG performance status \\< 3 (Appendix 1).\n* No known HIV disease or immunodeficiency\n* HBsAg-negative and Ab anti-HCV-negative patients.\n* Adequate bone marrow function (plt \\> 100000 mm3, Hb \\> 9 g/dl, ANC \\> 2.000 mm3)\n* Adequate renal function (serum creatinine \\< 2 times UNL)\n* Adequate hepatic function (SGOT/SGPT \\< 3 times UNL, bilirubin and alkaline phosphatase \\< 2 times UNL)\n* Adequate cardiac function (VEF ≥ 50%)\n* Absence of any psycological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule\n* Non-pregnant and non-lactating status for female patients. Adequate contraceptive measures during study participation for sexually active patients of childbearing potential.\n* No previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-site of the cervix and basal or squamous cell carcinoma of the skin and of other neoplasms without evidence of disease since at least 5 years.\n* No concurrent treatment with other experimental drugs.\n* Informed consent signed by the patient before registration"}, 'identificationModule': {'nctId': 'NCT00210366', 'briefTitle': 'Salvage Therapy With Idarubicin in Relapsing CNS Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'International Extranodal Lymphoma Study Group (IELSG)'}, 'officialTitle': 'Salvage Therapy With Idarubicin in Immunocompetent Patients With Relapsed or Refractory Primary Central Nervous System Lymphomas', 'orgStudyIdInfo': {'id': 'IELSG21'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Idarubicin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20132', 'city': 'Milan', 'state': 'Milan', 'country': 'Italy', 'facility': 'Servizio Radiochemioterapia - Ospedale San Raffaele', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'overallOfficials': [{'name': 'Andres JM Ferreri, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'San Raffaele Hospital - HSR Servizio di radiochemioterapia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'International Extranodal Lymphoma Study Group (IELSG)', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'International Extranodal Lymphoma Study Group', 'oldOrganization': 'IELSG'}}}}