Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2025-12-25 @ 8:22 PM
Study NCT ID:
NCT00199069
Status:
COMPLETED
Last Update Posted:
2023-03-17
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (05/93)
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': 'D001215', 'term': 'Asparaginase'}, {'id': 'D014750', 'term': 'Vincristine'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D007069', 'term': 'Ifosfamide'}, {'id': 'D003561', 'term': 'Cytarabine'}, {'id': 'D008942', 'term': 'Mitoxantrone'}, {'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'D015122', 'term': 'Mercaptopurine'}, {'id': 'D013866', 'term': 'Thioguanine'}, {'id': 'D013713', 'term': 'Teniposide'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D033581', 'term': 'Stem Cell Transplantation'}], 'ancestors': [{'id': 'D000581', 'term': 'Amidohydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'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': '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': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D001087', 'term': 'Arabinonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D000880', 'term': 'Anthraquinones'}, {'id': 'D000095322', 'term': 'Anthrones'}, {'id': 'D000873', 'term': 'Anthracenes'}, {'id': 'D011809', 'term': 'Quinones'}, {'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D013438', 'term': 'Sulfhydryl Compounds'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D005960', 'term': 'Glucosides'}, {'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': 'D017690', 'term': 'Cell Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 720}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1993-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2001-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-15', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2023-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '1999-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'remission rate, disease free survival, overall survival'}], 'secondaryOutcomes': [{'measure': 'death in induction, toxicity, time and dose compliance'}]}, 'conditionsModule': {'keywords': ['ALL', 'Treatment', 'De Novo', 'Adult'], 'conditions': ['Adult Acute Lymphocytic Leukemia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.studienregister-online.de', 'label': 'German Leukemia Trial Registry'}]}, 'descriptionModule': {'briefSummary': "The study evaluates the efficacy and tolerability of a risk- and subtype-adapted chemotherapy over one year, followed by randomized either intensified or conventional maintenance therapy. It includes a distinct protocol for the subgroup 'mature B-ALL',"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute Lymphocytic Leukemia\n* Age 15 - 65 years\n\nExclusion Criteria:\n\n* Serious secondary diseases which may compromise intensified chemotherapeutical treatment\n* Serious psychiatric diseases, which may compromise compliance with therapy\n* HIV-1 or HIV-2 Infection\n* Pretreatment \\> 2 weeks or chemotherapy other than Vincristine and Steroids\n* Patients without central diagnosis who cannot be allocated to a risk group'}, 'identificationModule': {'nctId': 'NCT00199069', 'briefTitle': 'German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (05/93)', 'organization': {'class': 'OTHER', 'fullName': 'Goethe University'}, 'officialTitle': 'Multicenter Trial for Treatment of Acute Lymphoblastic Leukemia in Adults (05/93)', 'orgStudyIdInfo': {'id': 'GMALL09'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Asparaginase', 'type': 'DRUG'}, {'name': 'Vincristine', 'type': 'DRUG'}, {'name': 'Daunorubicin, Adriamycin', 'type': 'DRUG'}, {'name': 'Cyclophosphamide', 'type': 'DRUG'}, {'name': 'Ifosfamide', 'type': 'DRUG'}, {'name': 'Cytarabine', 'type': 'DRUG'}, {'name': 'Mitoxantrone', 'type': 'DRUG'}, {'name': 'Methotrexate', 'type': 'DRUG'}, {'name': '6-Mercaptopurine', 'type': 'DRUG'}, {'name': '6-Thioguanine', 'type': 'DRUG'}, {'name': 'VM26', 'type': 'DRUG'}, {'name': 'Dexamethasone / Prednisolone', 'type': 'DRUG'}, {'name': 'CNS Irradiation', 'type': 'PROCEDURE'}, {'name': 'Mediastinal Irradiation', 'type': 'PROCEDURE'}, {'name': 'Stem Cell Transplantation', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Frankfurt', 'country': 'Germany', 'facility': 'University Hospital, Medical Dept. II', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}], 'overallOfficials': [{'name': 'Dieter Hoelzer, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Frankfurt, Medical Department II'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Goethe University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Deutsche Krebshilfe e.V., Bonn (Germany)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Study Coordinator', 'investigatorFullName': 'Nicola Goekbuget', 'investigatorAffiliation': 'Goethe University'}}}}