Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-02-24 @ 12:58 PM
Study NCT ID:
NCT01497002
Status:
COMPLETED
Last Update Posted:
2024-01-31
First Post:
2011-12-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the OSHO Protocol to a Standard Arm Protocol of the German AML Intergroup in Patients With AML>60a
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003561', 'term': 'Cytarabine'}, {'id': 'C098672', 'term': 'TNK1 protein, human'}], 'ancestors': [{'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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-09-15', 'size': 305021, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-01-19T06:42', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1222}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2018-07-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-30', 'studyFirstSubmitDate': '2011-12-21', 'studyFirstSubmitQcDate': '2011-12-21', 'lastUpdatePostDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event free survival', 'timeFrame': 'after 5 years', 'description': 'comparison of event free survival (OSHO arm versus Standard intergroup arm)'}], 'secondaryOutcomes': [{'measure': 'OS', 'timeFrame': 'at 5 years', 'description': 'Overall survival'}, {'measure': 'LFS', 'timeFrame': 'at 5 years', 'description': 'leukemia free survival'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['AML'], 'conditions': ['Acute Myeloid Leukaemia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://osho-studiengruppe.de/studie_069', 'label': 'AML 2004 OSHO #069 (Elderly)'}]}, 'descriptionModule': {'briefSummary': 'Improvement of the treatment-results in elderly patients with acute myeloid leukemia through intensification of consolidation chemotherapy and/or allografting as consolidative immunotherapy', 'detailedDescription': 'Measuring EFS depending on induction therapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of both sexes with age \\> 60 years and newly diagnosed acute myeloid leukaemia as defined by new WHO classification\n* written informed consent\n\nExclusion Criteria:\n\n* pretreatment of leukemia\n* no informed consent\n* simultaneous inclusion in other studies\n* mental disability\n* contraindication for intensive chemotherapy\n* AML FAB M3\n* contraindication for allogeneic stem cell transplantation\n* restriction of following organ functions:\n* creatinine-clearance \\< 50 ml/min\n* cardiac ejection fraction \\< 40 %\n* severe pulmonary restriction\n* bilirubin \\> 2x ULN; SGOT and SGPT \\> 4x ULN\n* uncontrolled hypertension\n* severe uncontrolled metabolism disturbance\n* Karnofsky-performance-score \\< 70%\n* hepatitis C\n* other malignancy\n* age of unrelated donor \\>70 years and age of related donor \\>75 years'}, 'identificationModule': {'nctId': 'NCT01497002', 'acronym': 'AML2004', 'briefTitle': 'Comparison of the OSHO Protocol to a Standard Arm Protocol of the German AML Intergroup in Patients With AML>60a', 'organization': {'class': 'OTHER', 'fullName': 'University of Leipzig'}, 'officialTitle': 'Randomized Phase III Study Comparing the OSHO Arm to the Standard Intergroup Arm.', 'orgStudyIdInfo': {'id': 'OSHO#069'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'standard arm', 'description': 'standard treatment arm', 'interventionNames': ['Drug: Cytarabine']}, {'type': 'EXPERIMENTAL', 'label': 'OSHO - intensified consolidation', 'description': 'Intermediate dose AraC', 'interventionNames': ['Drug: Cytarabine']}, {'type': 'EXPERIMENTAL', 'label': 'OSHO - allografting as consolidation', 'description': 'allogeneic stem cell Transplantation versus no transplantation', 'interventionNames': ['Biological: human stem cells']}], 'interventions': [{'name': 'Cytarabine', 'type': 'DRUG', 'otherNames': ['AraC'], 'description': 'Induction chemotherapy (1 or 2 courses): AraC 100 mg/m²/day i.v. 24h-infusion day 1-7 and Daunorubicin 60 mg/m² day 3+4+5. Consolidation chemotherapy (2 courses): AraC 1 g/m² i.v. 3h-infusion a 12h day 1+3+5.', 'armGroupLabels': ['OSHO - intensified consolidation', 'standard arm']}, {'name': 'human stem cells', 'type': 'BIOLOGICAL', 'description': 'Induction chemotherapy (1 or 2 courses): AraC 1 g/m² i.v. 3h-infusion a 12h day 1+3+5+7, Mitoxantrone 10 mg/m² day 1-3 and Pegfilgrastim 6 mg s.c. day 10. Consolidation chemotherapy (1 course): AraC 500 mg/m² i.v. 1h-infusion a 12h day 1+3+5, Mitoxantrone 10 mg/m² day 1+2 and Pegfilgrastim 6 mg s.c. day 8. Allogeneic stem cell transplantation using reduced intensity conditioning: Fludarabine 30 mg/m² day -4 - -2, TBI 200 cGy day 0; GvHD prophylaxis: cyclosporine A and mofetil mycofenolate', 'armGroupLabels': ['OSHO - allografting as consolidation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04103', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'University of Leipzig, Hematology', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}], 'overallOfficials': [{'name': 'Dietger Niederwieser, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Leipzig'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Leipzig', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}