Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2026-01-02 @ 10:38 AM
Study NCT ID:
NCT00199056
Status:
COMPLETED
Last Update Posted:
2023-03-20
First Post:
2005-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (06/99)
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': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'D014750', 'term': 'Vincristine'}, {'id': 'D014751', 'term': 'Vindesine'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D001215', 'term': 'Asparaginase'}, {'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D003561', 'term': 'Cytarabine'}, {'id': 'D015122', 'term': 'Mercaptopurine'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D013866', 'term': 'Thioguanine'}, {'id': 'D013713', 'term': 'Teniposide'}, {'id': 'D015255', 'term': 'Idarubicin'}, {'id': 'C024352', 'term': 'fludarabine'}, {'id': 'D007069', 'term': 'Ifosfamide'}, {'id': 'D033581', 'term': 'Stem Cell Transplantation'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'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': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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'}, {'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': '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': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'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'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D001087', 'term': 'Arabinonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D013438', 'term': 'Sulfhydryl Compounds'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D010078', 'term': 'Oxazines'}, {'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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 225}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2005-12', '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': '2003-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Remission rate,Remission duration,Disease free survival,Overall survival'}], 'secondaryOutcomes': [{'measure': 'Time and dose compliance,Realisation of SCT,Toxicity according to WHO,Course of MRD'}]}, 'conditionsModule': {'keywords': ['ALL', 'Treatment', 'De Novo', 'Adult'], 'conditions': ['Adult Acute Lymphocytic Leukemia']}, 'referencesModule': {'references': [{'pmid': '28751559', 'type': 'DERIVED', 'citation': 'Kobitzsch B, Gokbuget N, Schwartz S, Reinhardt R, Bruggemann M, Viardot A, Wasch R, Starck M, Thiel E, Hoelzer D, Burmeister T. Loss-of-function but not dominant-negative intragenic IKZF1 deletions are associated with an adverse prognosis in adult BCR-ABL-negative acute lymphoblastic leukemia. Haematologica. 2017 Oct;102(10):1739-1747. doi: 10.3324/haematol.2016.161273. Epub 2017 Jul 27.'}, {'pmid': '27561722', 'type': 'DERIVED', 'citation': 'Herold T, Schneider S, Metzeler KH, Neumann M, Hartmann L, Roberts KG, Konstandin NP, Greif PA, Braundl K, Ksienzyk B, Huk N, Schneider I, Zellmeier E, Jurinovic V, Mansmann U, Hiddemann W, Mullighan CG, Bohlander SK, Spiekermann K, Hoelzer D, Bruggemann M, Baldus CD, Dreyling M, Gokbuget N. Adults with Philadelphia chromosome-like acute lymphoblastic leukemia frequently have IGH-CRLF2 and JAK2 mutations, persistence of minimal residual disease and poor prognosis. Haematologica. 2017 Jan;102(1):130-138. doi: 10.3324/haematol.2015.136366. Epub 2016 Aug 25.'}, {'pmid': '22493293', 'type': 'DERIVED', 'citation': 'Gokbuget N, Stanze D, Beck J, Diedrich H, Horst HA, Huttmann A, Kobbe G, Kreuzer KA, Leimer L, Reichle A, Schaich M, Schwartz S, Serve H, Starck M, Stelljes M, Stuhlmann R, Viardot A, Wendelin K, Freund M, Hoelzer D; German Multicenter Study Group for Adult Acute Lymphoblastic Leukemia. Outcome of relapsed adult lymphoblastic leukemia depends on response to salvage chemotherapy, prognostic factors, and performance of stem cell transplantation. Blood. 2012 Sep 6;120(10):2032-41. doi: 10.1182/blood-2011-12-399287. Epub 2012 Apr 4.'}, {'pmid': '22442346', 'type': 'DERIVED', 'citation': 'Gokbuget N, Kneba M, Raff T, Trautmann H, Bartram CR, Arnold R, Fietkau R, Freund M, Ganser A, Ludwig WD, Maschmeyer G, Rieder H, Schwartz S, Serve H, Thiel E, Bruggemann M, Hoelzer D; German Multicenter Study Group for Adult Acute Lymphoblastic Leukemia. Adult patients with acute lymphoblastic leukemia and molecular failure display a poor prognosis and are candidates for stem cell transplantation and targeted therapies. Blood. 2012 Aug 30;120(9):1868-76. doi: 10.1182/blood-2011-09-377713. Epub 2012 Mar 22.'}, {'pmid': '19144982', 'type': 'DERIVED', 'citation': 'Burmeister T, Meyer C, Schwartz S, Hofmann J, Molkentin M, Kowarz E, Schneider B, Raff T, Reinhardt R, Gokbuget N, Hoelzer D, Thiel E, Marschalek R. The MLL recombinome of adult CD10-negative B-cell precursor acute lymphoblastic leukemia: results from the GMALL study group. Blood. 2009 Apr 23;113(17):4011-5. doi: 10.1182/blood-2008-10-183483. Epub 2009 Jan 14.'}], 'seeAlsoLinks': [{'url': 'http://www.studienregister-online.de', 'label': 'German Leukemia Trial Registry'}]}, 'descriptionModule': {'briefSummary': 'The study evaluates the efficacy and tolerability of an intensified induction and consolidation therapy. Thereafter patients receive individualised treatment stratified according to relapse risk with stem cell transplantation for patients with high and very high risk of relapse. Patients with standard risk receive further consolidation and reinduction chemotherapy. In parallel minimal residual disease (MRD) is evaluated. A MRD based risk stratification and treatment decision is developed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute lymphoblastic leukemia (pro-B, common, pre-B, early T, T)\n* Age 15-65 yrs (\\*55-65 years if biologically younger according to general condition)\n\nExclusion Criteria:\n\n* Severe comorbidity\n* Cytostatic pre-treatment\n* Pregnancy\n* Missing written informed consent'}, 'identificationModule': {'nctId': 'NCT00199056', 'briefTitle': 'German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (06/99)', 'organization': {'class': 'OTHER', 'fullName': 'Goethe University'}, 'officialTitle': 'Multicenter Trial for Treatment of Acute Lymphocytic Leukemia in Adults (Pilot Study 06/99)', 'orgStudyIdInfo': {'id': 'GMALL10'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Dexamethasone / Prednisolone', 'type': 'DRUG'}, {'name': 'Cyclophosphamide', 'type': 'DRUG'}, {'name': 'Methotrexate', 'type': 'DRUG'}, {'name': 'Vincristine / Vindesine', 'type': 'DRUG'}, {'name': 'Daunorubicin', 'type': 'DRUG'}, {'name': 'Asparaginase', 'type': 'DRUG'}, {'name': 'G-CSF', 'type': 'DRUG'}, {'name': 'Cytarabine', 'type': 'DRUG'}, {'name': '6-Mercaptopurine', 'type': 'DRUG'}, {'name': 'VP16', 'type': 'DRUG'}, {'name': 'Adriamycin', 'type': 'DRUG'}, {'name': 'Thioguanine', 'type': 'DRUG'}, {'name': 'VM26', 'type': 'DRUG'}, {'name': 'Idarubicin', 'type': 'DRUG'}, {'name': 'Fludarabine', 'type': 'DRUG'}, {'name': 'Ifosfamide', 'type': 'DRUG'}, {'name': 'CNS irradiation', 'type': 'PROCEDURE'}, {'name': 'Mediastinal irradiation (if residual tumor)', 'type': 'PROCEDURE'}, {'name': 'stem cell transplantation', 'type': 'PROCEDURE'}]}, '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,PhD', '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'}}}}