Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2026-02-01 @ 5:47 PM
Study NCT ID:
NCT00483132
Status:
COMPLETED
Last Update Posted:
2007-06-06
First Post:
2007-06-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Treatment High Risk and/or Low Risk Acute Lymphoblastic leukémia(ALL) Adults Stage III
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077190', 'term': 'Interferon alpha-2'}], 'ancestors': [{'id': 'D016898', 'term': 'Interferon-alpha'}, {'id': 'D007370', 'term': 'Interferon Type I'}, {'id': 'D007372', 'term': 'Interferons'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 232}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1994-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-06', 'completionDateStruct': {'date': '2002-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-06-05', 'studyFirstSubmitDate': '2007-06-05', 'studyFirstSubmitQcDate': '2007-06-05', 'lastUpdatePostDateStruct': {'date': '2007-06-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall survival', 'timeFrame': 'time to death'}], 'secondaryOutcomes': [{'measure': 'Efficacy of study treatments', 'timeFrame': 'time to end of treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Leukemia, Lymphocytic, Acute']}, 'referencesModule': {'references': [{'pmid': '15256423', 'type': 'RESULT', 'citation': 'Hunault M, Harousseau JL, Delain M, Truchan-Graczyk M, Cahn JY, Witz F, Lamy T, Pignon B, Jouet JP, Garidi R, Caillot D, Berthou C, Guyotat D, Sadoun A, Sotto JJ, Lioure B, Casassus P, Solal-Celigny P, Stalnikiewicz L, Audhuy B, Blanchet O, Baranger L, Bene MC, Ifrah N; GOELAMS (Groupe Ouest-Est des Leucemies Airgues et Maladies du Sang) Group. Better outcome of adult acute lymphoblastic leukemia after early genoidentical allogeneic bone marrow transplantation (BMT) than after late high-dose therapy and autologous BMT: a GOELAMS trial. Blood. 2004 Nov 15;104(10):3028-37. doi: 10.1182/blood-2003-10-3560. Epub 2004 Jul 15.'}]}, 'descriptionModule': {'briefSummary': 'Improved outcome of high risk lymphoblastic leukemia (ALL) with laite high dose therapy.\n\nHigh dose versus conventional therapy for adult low risk T-ALL and Lymphoblastic lymphoma (LBL).', 'detailedDescription': 'Comparison between two autograf therapeutic strategies in high risk patients Ramdomised comparison between maintenance treatment with or not interferon alpha 2 a'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* ALL high risk or low risk or lymphoblastic lymphoma\n* age 15-55 years old\n* informed consent signed\n\nExclusion Criteria:\n\n* patients previously treated with a chemotherapy or alpha-interferon\n* ALL 3 (burkitt like)'}, 'identificationModule': {'nctId': 'NCT00483132', 'briefTitle': 'Study of Treatment High Risk and/or Low Risk Acute Lymphoblastic leukémia(ALL) Adults Stage III', 'organization': {'class': 'OTHER', 'fullName': 'French Innovative Leukemia Organisation'}, 'officialTitle': 'Study of Treatment High Risk and/or Low Risk Acute Lymphoblastic leukémia(ALL) Adults Stage III', 'orgStudyIdInfo': {'id': 'GOELAL02'}}, 'armsInterventionsModule': {'interventions': [{'name': 'interferon alpha 2a', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '49000', 'city': 'Angers', 'state': 'Chu Angers', 'country': 'France', 'facility': 'INorbert IFRAH', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}], 'overallOfficials': [{'name': 'Norbert IFRAH, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'French Innovative Leukemia Organisation'}, {'name': 'Noël MILPIED', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'French Innovative Leukemia Organisation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'French Innovative Leukemia Organisation', 'class': 'OTHER'}}}}