Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT00169156
Status:
COMPLETED
Last Update Posted:
2017-03-13
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase II Study of Rituximab Combined With CHOP in T-cell Angio-immunoblastic Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069283', 'term': 'Rituximab'}, {'id': 'D011241', 'term': 'Prednisone'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D014750', 'term': 'Vincristine'}], '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': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'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': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-09', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Response Rate (ORR)', 'timeFrame': '8 months (4 cycles of treatment + 4 cycles of consolidation)', 'description': '\\[Complete response (CR), Complete response unconfirmed (CRu)\\] after the end of treatment.'}], 'secondaryOutcomes': [{'measure': 'Event-free survival (EFS) relapse for complete responders, disease progression, early discontinuation of treatment for toxicity or modification of treatment.', 'timeFrame': '2 years', 'description': 'Events being death from any cause'}, {'measure': 'Overall survival (OS)', 'timeFrame': '2 years'}, {'measure': 'Time to progression (TTF)', 'timeFrame': '2 years'}, {'measure': 'Disease-free survival (DFS).', 'timeFrame': '2 years'}, {'measure': 'number of SAE', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['T-cell angioimmunoblastic lymphoma', 'Rituximab'], 'conditions': ['Untreated T-cell Angioimmunoblastic Lymphoma']}, 'referencesModule': {'references': [{'pmid': '11781247', 'type': 'BACKGROUND', 'citation': 'Attygalle A, Al-Jehani R, Diss TC, Munson P, Liu H, Du MQ, Isaacson PG, Dogan A. Neoplastic T cells in angioimmunoblastic T-cell lymphoma express CD10. Blood. 2002 Jan 15;99(2):627-33. doi: 10.1182/blood.v99.2.627.'}, {'pmid': '12357368', 'type': 'BACKGROUND', 'citation': "Lome-Maldonado C, Canioni D, Hermine O, Delabesse E, Damotte D, Raffoux E, Gaulard P, Macintyre E, Brousse N; French Groupe d'Etude des Lymphomes de l'Adulte (GELA). Angio-immunoblastic T cell lymphoma (AILD-TL) rich in large B cells and associated with Epstein-Barr virus infection. A different subtype of AILD-TL? Leukemia. 2002 Oct;16(10):2134-41. doi: 10.1038/sj.leu.2402642."}, {'pmid': '11888076', 'type': 'BACKGROUND', 'citation': 'Zettl A, Lee SS, Rudiger T, Starostik P, Marino M, Kirchner T, Ott M, Muller-Hermelink HK, Ott G. Epstein-Barr virus-associated B-cell lymphoproliferative disorders in angloimmunoblastic T-cell lymphoma and peripheral T-cell lymphoma, unspecified. Am J Clin Pathol. 2002 Mar;117(3):368-79. doi: 10.1309/6UTX-GVC0-12ND-JJEU.'}, {'pmid': '9639502', 'type': 'BACKGROUND', 'citation': "Gisselbrecht C, Gaulard P, Lepage E, Coiffier B, Briere J, Haioun C, Cazals-Hatem D, Bosly A, Xerri L, Tilly H, Berger F, Bouhabdallah R, Diebold J. Prognostic significance of T-cell phenotype in aggressive non-Hodgkin's lymphomas. Groupe d'Etudes des Lymphomes de l'Adulte (GELA). Blood. 1998 Jul 1;92(1):76-82."}], 'seeAlsoLinks': [{'url': 'http://www.gela.org', 'label': "Official site of the Groupe d'Etude des Lymphomes de l'Adulte (In french)"}]}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy and the safety of a front-line treatment combining CHOP regimen and rituximab in patients aged 60 to 80 years with previously untreated AIL.', 'detailedDescription': 'This is a multicentric, open-label, non-randomized clinical study, evaluating the efficacy and the safety of a front-line treatment combining CHOP regimen and rituximab in patients aged 60 to 80 years with previously untreated AIL.\n\nIt is anticipated that 25 subjects will be enrolled over 2 years (from 2005 / 2007).Analysis performed every 5 patients (based on triangular test).\n\nThe duration of the treatment period is approximately 25 weeks and patients are followed until Death.\n\nThe total Duration of the study is expected to be 2.5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with histologically proven T-cell angioimmunoblastic lymphoma (AIL) on lymph node biopsy.\n* Aged from 60 to 80 years.\n* Patient not previously treated (except corticosteroids providing they have been initiated less than 10 days before inclusion).\n* ECOG performance status 0 to 2.\n* With a minimum of life expectancy \\> 3 months.\n* Negative HIV, HBV and HCV serological tests \\< 4 weeks (except after vaccination).\n* Having previously signed a written informed consent.\n\nExclusion Criteria:\n\n* Any other histological type of T-cell lymphoma.\n* Central nervous system or meningeal involvement by lymphoma.\n* Contra-indication to any drug included in the R-CHOP regimen.\n* Concurrent severe disease (according to the investigator's decision).\n* Active bacterial, viral or fungal infection.\n* Poor renal function (serum creatinine level \\> 150 µmol/L) or impaired liver function tests (total bilirubin level \\> 30 µmol/L, transaminases \\> 2.5 upper normal limits) unless they are related to the lymphoma.\n* Poor bone marrow reserve as defined by neutrophils \\< 1.5 x 109/L or platelets \\< 100 x 109/L, unless related to bone marrow infiltration.\n* Any history of cancer during the last 5 years, with the exception of non basal cell carcinoma of the skin or in situ carcinoma of the cervix.\n* Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.\n* Patient under tutelage."}, 'identificationModule': {'nctId': 'NCT00169156', 'briefTitle': 'A Phase II Study of Rituximab Combined With CHOP in T-cell Angio-immunoblastic Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Lymphoma Study Association'}, 'officialTitle': 'Study of the Efficacy and the Safety of First Line Treatment With CHOP Plus Rituximab (R-CHOP) in Patients Aged 60 to 80 Years With Previously Untreated T-cell Angioimmunoblastic Lymphoma (AIL).', 'orgStudyIdInfo': {'id': 'RAIL'}, 'secondaryIdInfos': [{'id': '2005-002602-37', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rituximab + CHOP', 'description': 'Rituximab + CHOP regimen Prednisone - Doxorubicine - Cyclophosphamide - Vincristine', 'interventionNames': ['Drug: Rituximab', 'Drug: Prednisone', 'Drug: Doxorubicine', 'Drug: Cyclophosphamide', 'Drug: Vincristine']}], 'interventions': [{'name': 'Rituximab', 'type': 'DRUG', 'description': '375 mg/m2 D1', 'armGroupLabels': ['Rituximab + CHOP']}, {'name': 'Prednisone', 'type': 'DRUG', 'description': '40 mg/m2 D1 to D5', 'armGroupLabels': ['Rituximab + CHOP']}, {'name': 'Doxorubicine', 'type': 'DRUG', 'description': '50 mg/m2 D1', 'armGroupLabels': ['Rituximab + CHOP']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'description': '750 mg/m2 D1', 'armGroupLabels': ['Rituximab + CHOP']}, {'name': 'Vincristine', 'type': 'DRUG', 'description': '1,4 mg/m2 D1', 'armGroupLabels': ['Rituximab + CHOP']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Créteil', 'country': 'France', 'facility': 'Hôpital Henri Mondor', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Saint Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '69495', 'city': 'Pierre-Bénite', 'country': 'France', 'facility': "Service d'Hématologie - Centre Hospitalier Lyon-Sud", 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'city': 'Rouen', 'country': 'France', 'facility': 'Centre Henri Becquerel', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}], 'overallOfficials': [{'name': 'Corinne Haioun, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hôpital Henri Mondor, Créteil, France'}, {'name': 'Bertrand Joly, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'C.H. Sud Francilien, Corbeil-Essonnes, France'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lymphoma Study Association', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}