Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-25 @ 8:40 PM
Study NCT ID:
NCT00140569
Status:
COMPLETED
Last Update Posted:
2005-09-01
First Post:
2005-08-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Randomized Study for Patients With Follicular Lymphoma Needing Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008224', 'term': 'Lymphoma, Follicular'}], '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': 'D007372', 'term': 'Interferons'}, {'id': 'C024352', 'term': 'fludarabine'}, {'id': 'D014916', 'term': 'Whole-Body Irradiation'}, {'id': 'D014182', 'term': 'Transplantation, Autologous'}], 'ancestors': [{'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1994-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-08', 'completionDateStruct': {'date': '2004-01'}, 'lastUpdateSubmitDate': '2005-08-31', 'studyFirstSubmitDate': '2005-08-31', 'studyFirstSubmitQcDate': '2005-08-31', 'lastUpdatePostDateStruct': {'date': '2005-09-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival'}], 'secondaryOutcomes': [{'measure': 'Overall survival'}, {'measure': 'Toxicity'}, {'measure': 'Response rates'}]}, 'conditionsModule': {'keywords': ['follicular lymphoma', 'CHVP + interferon', 'fludarabine', 'autotransplant'], 'conditions': ['Follicular Lymphoma']}, 'referencesModule': {'references': [{'pmid': '10586336', 'type': 'RESULT', 'citation': "Coiffier B, Neidhardt-Berard EM, Tilly H, Belanger C, Bouabdallah R, Haioun C, Brice P, Peaud PY, Pico JL, Janvier M, Solal-Celigny P, Brousse N. Fludarabine alone compared to CHVP plus interferon in elderly patients with follicular lymphoma and adverse prognostic parameters: a GELA study. Groupe d'Etudes des Lymphomes de l'Adulte. Ann Oncol. 1999 Oct;10(10):1191-7. doi: 10.1023/a:1008347425795."}], 'seeAlsoLinks': [{'url': 'http://www.gela.org', 'label': "Official site of the Groupe d'Etudes des Lymphomes de l'Adulte (In french)"}]}, 'descriptionModule': {'briefSummary': '2 parallel studies.\n\n* For young patients (18-60 years): randomization between CHVP + interferon for 18 months and 4 CHOP followed by autotransplant after TBI\n* For elderly patients (\\>60 years): randomization between CHVP + interferon for 18 months and fludarabine 5 days every months for 6 months', 'detailedDescription': '2 parallel studies.\n\n* For young patients (18-60 years): randomization between CHVP + interferon for 18 months and 4 CHOP followed by autotransplant after TBI\n* For elderly patients (\\>60 years): randomization between CHVP + interferon for 18 months and fludarabine 5 days every months for 6 months'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* study 1 (young patients): being less than 61 years old with a follicular lymphoma and needing to be treated because of high LDH level, high beta-2 microglobulin level, poor performance status, or large tumoral mass (lymph node \\>7 cm, symptomatic splenomegaly, pleura effusion, or sign of compression by the tumor mass)\n* study 2 (elderly patients): being older than 60 years with a follicular lymphoma and needing to be treated because of high LDH level, high beta-2 microglobulin level, poor performance status, or large tumoral mass (lymph node \\>7 cm, symptomatic splenomegaly, pleura effusion, or sign of compression by the tumor mass)\n\nExclusion Criteria:\n\n* contra-indication to anthracycline or interferon\n* transformation into large cell lymphoma\n* previous treatment\n* localized stage without criteria of large tumor mass\n* patients HIV+'}, 'identificationModule': {'nctId': 'NCT00140569', 'briefTitle': 'Randomized Study for Patients With Follicular Lymphoma Needing Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Lymphoma Study Association'}, 'officialTitle': 'Randomized Study for Patients With Follicular Lymphoma Needing Treatment', 'orgStudyIdInfo': {'id': 'Gelf-94'}}, 'armsInterventionsModule': {'interventions': [{'name': 'CHVP + interferon', 'type': 'PROCEDURE'}, {'name': 'fludarabine', 'type': 'DRUG'}, {'name': 'CHOP + TBI and autotransplant', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Yvoir', 'country': 'Belgium', 'facility': "Groupe d'atude des lymphome de l'adulte", 'geoPoint': {'lat': 50.3279, 'lon': 4.88059}}, {'zip': '94010', 'city': 'Créteil', 'country': 'France', 'facility': 'Hôpital Henri Mondor', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '69008', 'city': 'Lyon', 'country': 'France', 'facility': 'Centre Léon Bérard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '75010', '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}}, {'zip': '51092', 'city': 'Reims', 'country': 'France', 'facility': 'Centre Hospitalier Robert Debré', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '76038', 'city': 'Rouen', 'country': 'France', 'facility': 'Centre Henri Becquerel', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'city': 'Villejuif', 'country': 'France', 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'overallOfficials': [{'name': 'Bertrand Coiffier, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospices Civils de Lyon'}, {'name': 'Catherine Sebban, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Leon Berard'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lymphoma Study Association', 'class': 'OTHER'}}}}