Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2026-02-24 @ 2:06 PM
Study NCT ID:
NCT00537550
Status:
COMPLETED
Last Update Posted:
2007-10-01
First Post:
2007-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adult ALL Treatment at Diagnosis
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': 'D014750', 'term': 'Vincristine'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D001215', 'term': 'Asparaginase'}, {'id': 'D008727', 'term': 'Methotrexate'}], 'ancestors': [{'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': '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': 'D000581', 'term': 'Amidohydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-09', 'completionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-09-28', 'studyFirstSubmitDate': '2007-09-27', 'studyFirstSubmitQcDate': '2007-09-28', 'lastUpdatePostDateStruct': {'date': '2007-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-01', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ALL', 'Adult'], 'conditions': ['Leukemia, Lymphocytic, Acute']}, '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 has been designed to give participating centers the possibility of better understanding the diagnostic and prognostic factors of ALL patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of acute lymphoblastic leukemia (ALL)\n* Negative myeloperoxidase stain\n* Phenotype T (ALL-T) and B(ALL-B)\n\nExclusion Criteria:\n\n* Creatinine \\> 2.5mg/dL after adequate hydratation\n* LVEF \\<50%\n* Presence of documented infections not responding to antibiotic and/or antifungal therapy\n* Presence of concomitant malignant diseases\n* Absence of any psychological condition that does not allow to intake high doses of cortisone\n* Patients who have received any antineoplastic chemiotherapy for more than 5 days\n* Patients who have received any steroids for more than 10 days'}, 'identificationModule': {'nctId': 'NCT00537550', 'acronym': 'LAL2000', 'briefTitle': 'Adult ALL Treatment at Diagnosis', 'organization': {'class': 'OTHER', 'fullName': "Gruppo Italiano Malattie EMatologiche dell'Adulto"}, 'officialTitle': 'GIMEMA Guidelines for the Treatment of Adult ALL Affected Patients at Diagnosis', 'orgStudyIdInfo': {'id': 'LAL2000'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Vincristine', 'type': 'DRUG', 'description': 'Steroids pre-treatment'}, {'name': 'Vincristin, Daunorubicine, Asparaginase, Methotrexate', 'type': 'DRUG', 'description': 'Induction therapy'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Avellino', 'country': 'Italy', 'facility': 'Az. Ospedaliera S. G. Moscati', 'geoPoint': {'lat': 40.91494, 'lon': 14.79103}}, {'city': 'Bologna', 'country': 'Italy', 'facility': 'Ist.Ematologia e Oncologia Medica L.e A. Seragnoli', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'city': 'Brindisi', 'country': 'Italy', 'facility': 'Ospedale Reg. A di Summa', 'geoPoint': {'lat': 40.63215, 'lon': 17.93607}}, {'city': 'Potenza', 'country': 'Italy', 'facility': 'Istituto di Ematologia- Ospedale San Carlo', 'geoPoint': {'lat': 40.64175, 'lon': 15.80794}}, {'zip': '37134', 'city': 'Verona', 'country': 'Italy', 'facility': 'Policlinico G.B. Rossi', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}], 'overallOfficials': [{'name': 'Franco MANDELLI, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Università degli Studi di Roma "La Sapienza"'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Gruppo Italiano Malattie EMatologiche dell'Adulto", 'class': 'OTHER'}}}}