Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT00439920
Status:
UNKNOWN
Last Update Posted:
2018-10-23
First Post:
2007-02-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
GIMEMA LAL 0496: High-dose Anthracycline in the Induction Regimen for the Treatment of Adult ALL.
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': 'D018943', 'term': 'Anthracyclines'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '1996-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-22', 'studyFirstSubmitDate': '2007-02-23', 'studyFirstSubmitQcDate': '2007-02-23', 'lastUpdatePostDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with complete response', 'description': 'Patients are followed-up for response till death'}], 'secondaryOutcomes': [{'measure': 'Number of patients that reach disease-free-survival', 'description': 'Patients are followed-up for response till death'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ALL'], 'conditions': ['Acute Lymphoblastic Leukemia']}, 'referencesModule': {'references': [{'pmid': '34048072', 'type': 'DERIVED', 'citation': 'Piciocchi A, Messina M, Elia L, Vitale A, Soddu S, Testi AM, Chiaretti S, Mancini M, Albano F, Spadano A, Krampera M, Bonifacio M, Cairoli R, Vetro C, Colella F, Ferrara F, Cimino G, Bassan R, Fazi P, Vignetti M. Prognostic impact of KMT2A-AFF1-positivity in 926 BCR-ABL1-negative B-lineage acute lymphoblastic leukemia patients treated in GIMEMA clinical trials since 1996. Am J Hematol. 2021 Sep 1;96(9):E334-E338. doi: 10.1002/ajh.26253. Epub 2021 Jun 9. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The present study aims at verifying the state of the art in what this illness concerns and at organizing a centralized samples analysis.', 'detailedDescription': 'The present trial is a prospective multicentric GIMEMA study, in which adult ALL patients are extensively analyzed at diagnosis by a multiparametric approach including CC and molecular analysis for the following gene rearrangements: BCR-ABL, MLL-AF4, E2A-PBX1, TEL-AML1, MLL, p15 and p16 deletion in order to give place to a carefully characterization of the genetic lesions occurring in adult ALL and to evaluate their prognostic significance in a large cohort of patients homogeneously treated.\n\nThis study requires a central handling and analysis of bone marrow (BM) or peripheral blood samples at presentation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 16-60\n* Diagnosed with previously untreated T-ALL and B-ALL\n\nExclusion Criteria:\n\n* previously treated ALL patients\n* L3 B-ALL'}, 'identificationModule': {'nctId': 'NCT00439920', 'briefTitle': 'GIMEMA LAL 0496: High-dose Anthracycline in the Induction Regimen for the Treatment of Adult ALL.', 'organization': {'class': 'OTHER', 'fullName': "Gruppo Italiano Malattie EMatologiche dell'Adulto"}, 'officialTitle': 'GIMEMA LAL 0496: High-dose Anthracycline in the Induction Regimen for the Treatment of Adult Acute Lymphoblastic Leukemia. A Prospective Multicentric GIMEMA Trial.', 'orgStudyIdInfo': {'id': 'LAL0496'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High-dose anthracycline', 'interventionNames': ['Drug: High-dose anthracycline']}], 'interventions': [{'name': 'High-dose anthracycline', 'type': 'DRUG', 'armGroupLabels': ['High-dose anthracycline']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Franco Mandelli, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Università degli Studi di Roma "La Sapienza"'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Gruppo Italiano Malattie EMatologiche dell'Adulto", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}