Ignite Creation Date:
2026-03-26 @ 3:21 PM
Ignite Modification Date:
2026-04-01 @ 9:48 PM
Study NCT ID:
NCT00556127
Status:
COMPLETED
Last Update Posted:
2007-11-09
First Post:
2007-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rituximab in Addition to Chemotherapy With Autologous Stem Cell Transplantation as Treatment Diffuse Large B-Cell Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': 'D015251', 'term': 'Epirubicin'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D014750', 'term': 'Vincristine'}, {'id': 'D011241', 'term': 'Prednisone'}, {'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D008942', 'term': 'Mitoxantrone'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D002330', 'term': 'Carmustine'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'D008558', 'term': 'Melphalan'}, {'id': 'D011878', 'term': 'Radiotherapy'}], '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': 'D004317', 'term': 'Doxorubicin'}, {'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'}, {'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'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D000880', 'term': 'Anthraquinones'}, {'id': 'D000095322', 'term': 'Anthrones'}, {'id': 'D000873', 'term': 'Anthracenes'}, {'id': 'D011809', 'term': 'Quinones'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D009607', 'term': 'Nitrosourea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009603', 'term': 'Nitroso Compounds'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D010649', 'term': 'Phenylalanine'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-11', 'completionDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-11-08', 'studyFirstSubmitDate': '2007-11-08', 'studyFirstSubmitQcDate': '2007-11-08', 'lastUpdatePostDateStruct': {'date': '2007-11-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Failure-free survival', 'timeFrame': 'Three years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Large B-cell Lymphoma', 'Rituximab', 'ASCT'], 'conditions': ['Diffuse Large B-Cell Lymphoma', 'POOR PROGNOSIS']}, 'descriptionModule': {'briefSummary': 'The purpose of this trial was to evaluate efficacy and safety of adding Rituximab to dose-dense and High-Dose Chemotherapy (HDC) with Autologous Stem Cell Transplantation (ASCT) as first line treatment in young patients with DLBCL at Intermediate-High and High risk aaIPI score'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* previously untreated aggressive B-cell lymphoma (Diffuse Large B-Cell,\n* Primary Mediastinal,\n* Follicular grade III b Lymphoma);\n* age 18 to 60;\n* III-IV Ann Arbor stage;\n* 0-2 Eastern Cooperative Oncology Group (ECOG) performance status (PS);\n* intermediate-high (IH) and high (H) risk score according to age-adjusted International Prognostic Index (IPI).\n* Patients with Primary Mediastinal Lymphoma were included only if they had advanced stage III or IV disease.\n\nExclusion Criteria:\n\n* HIV,\n* hepatitis B or C virus seropositivity;\n* CNS involvement at diagnosis;\n* abnormal renal, pulmonary and hepatic function;\n* left ventricular ejection fraction less than 45%;\n* pregnancy.'}, 'identificationModule': {'nctId': 'NCT00556127', 'acronym': 'DLBCL', 'briefTitle': 'Rituximab in Addition to Chemotherapy With Autologous Stem Cell Transplantation as Treatment Diffuse Large B-Cell Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie'}, 'officialTitle': 'Programma di Terapia Per Pazienti Affetti da Linfoma Diffuso a Grandi Cellule B CD20 Positive', 'orgStudyIdInfo': {'id': 'GIMURELL-DLBCL'}, 'secondaryIdInfos': [{'id': 'Eudract Number 2004-000543-19'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Rituximab', 'Drug: Epirubicin', 'Drug: Cyclophosphamide', 'Drug: Vincristine', 'Drug: Prednisone', 'Drug: Granulocyte-colony-stimulating factor', 'Drug: Mitoxantrone', 'Drug: Cytarabine ARA-C', 'Drug: Dexamethasone', 'Drug: Carmustine BCNU', 'Drug: Etoposide', 'Drug: Melphalan', 'Radiation: Radiotherapy', 'Procedure: PBSC reinfusion']}], 'interventions': [{'name': 'Rituximab', 'type': 'DRUG', 'description': '375 mg/m2 on day 1', 'armGroupLabels': ['1']}, {'name': 'Epirubicin', 'type': 'DRUG', 'description': '110 mg/m2 on day 3', 'armGroupLabels': ['1']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'description': '1200 mg/m2 on day 3', 'armGroupLabels': ['1']}, {'name': 'Vincristine', 'type': 'DRUG', 'description': '1.4 mg/m2 (maximum 2 mg) on day 3', 'armGroupLabels': ['1']}, {'name': 'Prednisone', 'type': 'DRUG', 'description': '40 mg/m2 from day 1 to 5', 'armGroupLabels': ['1']}, {'name': 'Granulocyte-colony-stimulating factor', 'type': 'DRUG', 'description': '(G-CSF 5 μg/Kg/day) from day 5 to day 11', 'armGroupLabels': ['1']}, {'name': 'Mitoxantrone', 'type': 'DRUG', 'description': '8 mg/m2 for 3-day', 'armGroupLabels': ['1']}, {'name': 'Cytarabine ARA-C', 'type': 'DRUG', 'description': '2 g/m2/12 hours for six doses in 3-hour infusion', 'armGroupLabels': ['1']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'description': '4 mg/m2/12 hours before ARA-C administration', 'armGroupLabels': ['1']}, {'name': 'Carmustine BCNU', 'type': 'DRUG', 'description': '300 mg/m2 on day -7', 'armGroupLabels': ['1']}, {'name': 'Etoposide', 'type': 'DRUG', 'description': '100 mg/m2/12 hours', 'armGroupLabels': ['1']}, {'name': 'Melphalan', 'type': 'DRUG', 'description': '140 mg/m2 on day -2', 'armGroupLabels': ['1']}, {'name': 'Radiotherapy', 'type': 'RADIATION', 'description': 'Involved Field Radiotherapy (IF-RT)', 'armGroupLabels': ['1']}, {'name': 'PBSC reinfusion', 'type': 'PROCEDURE', 'description': 'ASCT', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alessandria', 'country': 'Italy', 'facility': 'Az. Ospedaliera SS. Antonio e Biagio e Cesare Arrigo', 'geoPoint': {'lat': 44.90924, 'lon': 8.61007}}, {'city': 'Aosta', 'country': 'Italy', 'facility': 'Ospedale Regionale, Divisione di Oncologia,', 'geoPoint': {'lat': 45.73764, 'lon': 7.31722}}, {'city': 'Bari', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Ospedale Policlinico Consorziale', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'city': 'Biella', 'country': 'Italy', 'facility': 'Osp. degli Infermi', 'geoPoint': {'lat': 45.56304, 'lon': 8.05796}}, {'city': 'Brescia', 'country': 'Italy', 'facility': 'Spedali Civili', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'city': 'Cagliari', 'country': 'Italy', 'facility': 'Centro Trapianti Midollo Osseo, P.O. Businco', 'geoPoint': {'lat': 39.23054, 'lon': 9.11917}}, {'city': 'Monza', 'country': 'Italy', 'facility': 'Ospedale S. Gerardo', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}, {'city': 'Novara', 'country': 'Italy', 'facility': 'Osp. maggiore della Carità', 'geoPoint': {'lat': 45.44694, 'lon': 8.62118}}, {'city': 'Perugia', 'country': 'Italy', 'facility': 'Università degli Studi Policlinico Monteluce', 'geoPoint': {'lat': 43.1122, 'lon': 12.38878}}, {'city': 'Torino', 'country': 'Italy', 'facility': 'Divisione di Medicina, Ospedale Generale E. Agnelli, Pinerolo', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'city': 'Torino', 'country': 'Italy', 'facility': 'Istituto per la Ricerca e la Cura del Cancro, Candiolo', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'city': 'Torino', 'country': 'Italy', 'facility': 'Osp. S. Giovanni Battista "Molinette"', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'city': 'Torino', 'country': 'Italy', 'facility': 'Ospedale di Chivasso e Ivrea', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'city': 'Torino', 'country': 'Italy', 'facility': 'Stabilimento Ospedaliero Ciriè -', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}], 'overallOfficials': [{'name': 'Umberto Vitolo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'S.C. Ematologia II - OSP.S. GIOV.BATTISTA MOLINETTE - TORINO (TO) -'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie', 'class': 'OTHER'}}}}