Ignite Creation Date:
2025-12-24 @ 2:09 PM
Ignite Modification Date:
2026-03-26 @ 5:43 AM
Study NCT ID:
NCT00842595
Status:
COMPLETED
Last Update Posted:
2013-07-24
First Post:
2009-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy , Safety of Treatment R NIMP for Relapsed Aggressive Lymphomas
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': 'D000069283', 'term': 'Rituximab'}, {'id': 'D000077235', 'term': 'Vinorelbine'}, {'id': 'D007069', 'term': 'Ifosfamide'}, {'id': 'D008942', 'term': 'Mitoxantrone'}, {'id': 'D011241', 'term': 'Prednisone'}], 'ancestors': [{'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D000880', 'term': 'Anthraquinones'}, {'id': 'D000095322', 'term': 'Anthrones'}, {'id': 'D000873', 'term': 'Anthracenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D011809', 'term': 'Quinones'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-23', 'studyFirstSubmitDate': '2009-02-11', 'studyFirstSubmitQcDate': '2009-02-11', 'lastUpdatePostDateStruct': {'date': '2013-07-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete remission rate', 'timeFrame': 'CR AFTER 3 R NIMP COURSES'}], 'secondaryOutcomes': [{'measure': 'overall remission rate', 'timeFrame': 'OS after 3 R NIMP COURSES'}, {'measure': 'Toxicity', 'timeFrame': 'R NIMP TOLERANCE'}, {'measure': 'Pharmacoeconomy', 'timeFrame': 'treatment phramacoeconomy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['relapsed aggressive B-cell lymphoma', 'Chemotherapy'], 'conditions': ['Diffuse Large B-Cell Lymphoma']}, 'descriptionModule': {'briefSummary': "The primary objective of the protocol is to estimate the complete response rate of three courses of the association of rituximab, navelbine, ifosfamide, mitoxantrone, and prednisone in relapsed aggressive non hodgkin's B-cell lymphoma", 'detailedDescription': "Phase II study of the efficacy and toxicity of rituximab, navelbine, ifosfamide, mitoxantrone, and prednisone in relapsed aggressive non hodgkin's B-cell lymphoma.\n\nThe study intervention is an administration of 3 courses of the abovementioned drugs, witch doses are detailed below. Remission is assessed and the investigator is free to proceed with any kind of consolidation , he decides best for the patient( high dose or standard chemotherapy).\n\nThe addition of Rituximab the the NIMP protocol is warranted on the basis of previous publications wtich have shown a significant advantage in addition to chemotherapy in complete remission rate and in overall survival.\n\nNavelbine has shown an interesting activity in lymphoma relapse. Mitoxantrone has a good toxicity profile for patients who have prevously received anthracyclines, and there is not so much cross resistance between the two drugs.\n\nIfosfamide is commonly used in the treatment of relapsed and refractory lymphoma, because of its low hematologic toxicity profile and good antitumor activity."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both genders, between 18 and 75 years old\n* CD 20+ large cell lymphoma\n* In first relapse\n* No previous autologous stem cell transplantation or relapsing more than 12 months after an autologous stem cell transplantation\n* Ann Arbor stage I, II, III ou IV\n* ECOG 0,1 or 2\n* Signed informed consent\n\nExclusion Criteria:\n\n* age: before 18 and more than 75 years old\n* other type of lymphoma\n* Informed consent not signed'}, 'identificationModule': {'nctId': 'NCT00842595', 'briefTitle': 'Efficacy , Safety of Treatment R NIMP for Relapsed Aggressive Lymphomas', 'organization': {'class': 'OTHER', 'fullName': 'French Innovative Leukemia Organisation'}, 'officialTitle': 'Phase II Study of Treatment of Relapsed Agressive Lymphomas', 'orgStudyIdInfo': {'id': 'R NIMP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'R NIMP', 'description': '(Mabthera®) Rituximab IV 375 mg/m²day 1 (Navelbine ®)Vinorelbine IV 25mg/m² day 1 and day 5 (Novantrone®)Mitoxantrone IV 10 mg/m² day 1 (Holoxan®)Ifostamide IV 1000 mg/m²day 1 to day 5 (Cortancyl®)prednisone oral day 1 to day 5', 'interventionNames': ['Drug: rituximab', 'Drug: vinorelbine', 'Drug: ifosfamide', 'Drug: Mitoxantrone', 'Drug: Prednisone']}], 'interventions': [{'name': 'rituximab', 'type': 'DRUG', 'otherNames': ['(Mabthera ® )Rituximab IV 375 mg/m²day'], 'description': '6 courses every 28 days', 'armGroupLabels': ['R NIMP']}, {'name': 'vinorelbine', 'type': 'DRUG', 'otherNames': ['(Navelbine ®) Vinorelbine IV 25mg/m² day 1 and day 5'], 'description': '6 courses every 28 days', 'armGroupLabels': ['R NIMP']}, {'name': 'ifosfamide', 'type': 'DRUG', 'otherNames': ['(Holoxan®)Ifostamide 1000mg/m² day 1 to day 5'], 'description': '6 courses every 28 days', 'armGroupLabels': ['R NIMP']}, {'name': 'Mitoxantrone', 'type': 'DRUG', 'otherNames': ['(Novantrone®) Mitoxantrone 10mg/m² day1'], 'description': '6 courses every 28 days', 'armGroupLabels': ['R NIMP']}, {'name': 'Prednisone', 'type': 'DRUG', 'otherNames': ['(Cortancyl®)Prednisone 1m/kg day 1 to day 5'], 'description': '6 courses every 28 days', 'armGroupLabels': ['R NIMP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital COCHIN', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Emmanuel GYAN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'French Innovative Leukemia Organisation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'French Innovative Leukemia Organisation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}