Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2025-12-28 @ 9:34 PM
Study NCT ID:
NCT00199095
Status:
COMPLETED
Last Update Posted:
2023-03-20
First Post:
2005-09-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Elderly Patients (>65 Years) With Acute Lymphoblastic Leukemia
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': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D003561', 'term': 'Cytarabine'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D015255', 'term': 'Idarubicin'}, {'id': 'D007069', 'term': 'Ifosfamide'}, {'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'D015122', 'term': 'Mercaptopurine'}, {'id': 'D013713', 'term': 'Teniposide'}, {'id': 'D014750', 'term': 'Vincristine'}], 'ancestors': [{'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': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001087', 'term': 'Arabinonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D013438', 'term': 'Sulfhydryl Compounds'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1997-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2003-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-16', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Results of induction therapy,Distribution of entry criteria,Treatment feasibility,Relapse rate and localisation,Death in CR,Remission duration, survival and leukemia free survival,Prognostic factors,Quality of life'}]}, 'conditionsModule': {'keywords': ['ALL', 'Elderly', 'Chemotherapy'], 'conditions': ['Adult Acute Lymphocytic Leukemia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.studienregister-online.de', 'label': 'German Leukemia Trial Registry'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to test feasibility and efficacy of a dose reduced chemotherapy in elderly patients with newly diagnosed acute lymphoblastic leukemia. The regimen consists of induction phase I and II followed by cyclic consolidation cycles, reinduction and maintenance therapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of acute lymphoblastic leukemia (pro-B,common,pre-B,pre-T,Thy-,mature T, B-ALL)\n* age \\> 65 years\n* written informed consent\n* Karnofsky \\> 50% (if not mainly caused by leukemia)\n* laboratory at diagnosis or after supportive pre-treatment Creatinine \\< 2 mg/dl Uric Acid \\< 8 mg/dl Bilirubin \\< 1.5 mg/dl ALA, ASA,AP \\< 2.5 x ULN\n\nExclusion Criteria:\n\n* severe second diseases (e.g. renal failure, cardiomyopathy etc., not caused by leukemia) that exclude treatment according to the protocol\n* severe psychiatric illness or other circumstances which may compromise cooperation\n* active second neoplasia\n* clinical signs of life threatening infections or bleeding, uncontrollable prior to chemotherapy'}, 'identificationModule': {'nctId': 'NCT00199095', 'briefTitle': 'Treatment of Elderly Patients (>65 Years) With Acute Lymphoblastic Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'Goethe University'}, 'officialTitle': 'Pilot Study for Treatment of Elderly Patients (>65 Years) With Acute Lymphoblastic Leukemia', 'orgStudyIdInfo': {'id': 'GMALL11'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Adriamycin', 'type': 'DRUG'}, {'name': 'Cyclophosphamide', 'type': 'DRUG'}, {'name': 'Cytarabine', 'type': 'DRUG'}, {'name': 'Dexamethasone', 'type': 'DRUG'}, {'name': 'Idarubicin', 'type': 'DRUG'}, {'name': 'Ifosfamide', 'type': 'DRUG'}, {'name': 'Methotrexate', 'type': 'DRUG'}, {'name': 'Mercaptopurine', 'type': 'DRUG'}, {'name': 'VM26', 'type': 'DRUG'}, {'name': 'Vincristine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60590', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'University Hospital, Medical Dept. II', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}], 'overallOfficials': [{'name': 'Dieter Hoelzer, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital Frankfurt, Medical Dept. II'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Goethe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of GMALL', 'investigatorFullName': 'Nicola Goekbuget', 'investigatorAffiliation': 'Goethe University'}}}}