Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2026-01-07 @ 4:14 AM
Study NCT ID:
NCT00536393
Status:
COMPLETED
Last Update Posted:
2007-11-01
First Post:
2007-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Disseminated High Grade Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'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': 'D004317', 'term': 'Doxorubicin'}], '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', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-09', 'completionDateStruct': {'date': '2004-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-10-31', 'studyFirstSubmitDate': '2007-09-26', 'studyFirstSubmitQcDate': '2007-09-26', 'lastUpdatePostDateStruct': {'date': '2007-11-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hematologic toxicity', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'response rate', 'timeFrame': '6 months'}, {'measure': 'EFS and OS', 'timeFrame': '6 months'}, {'measure': 'Cardiac toxicity', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['diffuse larg cells lymphoma', 'chemotherapy', 'toxicity', 'diffuse high grade lymphoma'], 'conditions': ['Lymphoma']}, 'descriptionModule': {'briefSummary': 'Interest of the use of pegylated liposomal doxorubicin (caélyx)', 'detailedDescription': 'R CHOP is a good standard in the treatment of diffuse high grade lymphoma. Howeverin elderly patients it is often toxic, specially with haematologic and cardiac toxicities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* high grade lymphoma\n* disseminated\n* \\> 60 years old and \\< 75\n* informed consent signed\n* cardiac state compatible with antracyclin\n* ECOG \\</= 2\n\nExclusion Criteria:\n\n* patients \\> 75 years old\n* Cardiac insufficiency'}, 'identificationModule': {'nctId': 'NCT00536393', 'briefTitle': 'Treatment of Disseminated High Grade Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'French Innovative Leukemia Organisation'}, 'officialTitle': 'Phase III Study of Treatment of Disseminated and Agressive Lymphoma R CHOP Versus R CLOP( With Liposomal Doxorubicin)', 'orgStudyIdInfo': {'id': 'GOELAMS 0804'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Doxorubicine', 'description': 'CHOP 8 courses every 21 days', 'interventionNames': ['Drug: Doxorubicin']}, {'type': 'EXPERIMENTAL', 'label': 'Doxorubicine pegylated', 'description': 'CLOP 8 courses every 21 days', 'interventionNames': ['Drug: Doxorubicin pegylated']}], 'interventions': [{'name': 'Doxorubicin', 'type': 'DRUG', 'armGroupLabels': ['Doxorubicine']}, {'name': 'Doxorubicin pegylated', 'type': 'DRUG', 'armGroupLabels': ['Doxorubicine pegylated']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72015', 'city': 'Le Mans', 'country': 'France', 'facility': 'Clinique Victor Hugo', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}], 'overallOfficials': [{'name': 'Guillaume CARTRON, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'French Innovative Leukemia Organisation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'French Innovative Leukemia Organisation', 'class': 'OTHER'}}}}