Ignite Creation Date:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2025-12-26 @ 2:41 PM
Study NCT ID:
NCT00125606
Status:
TERMINATED
Last Update Posted:
2012-12-18
First Post:
2005-07-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase 3 Trial for AML Patients in CR2 Comparing 8Gy TBI /Fludarabine to Conditioning With TBI 12Gy/Cyclophosphamide
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'whyStopped': 'insufficient patient recruitement', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-17', 'studyFirstSubmitDate': '2005-07-26', 'studyFirstSubmitQcDate': '2005-07-29', 'lastUpdatePostDateStruct': {'date': '2012-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'treatment related mortality'}], 'secondaryOutcomes': [{'measure': 'event free survival'}, {'measure': 'overall survival'}, {'measure': 'cumulative incidence of acute and chronic graft-versus-host disease (GvHD)'}, {'measure': 'activity index (ECOG)'}, {'measure': 'organ function'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['AML', 'allogeneic HSCT', 'reduced intensity conditioning', 'randomized trail'], 'conditions': ['Acute Myeloid Leukemia']}, 'descriptionModule': {'briefSummary': 'For patients with acute myeloid leukemia (AML), allogeneic hematopoetic stem cell transplantation (HSCT) is one of the most potent treatment options currently available. In order to overcome the high risk of fatal treatment-related complications, reduced intensity and nonmyeloablative conditioning regimens for allogeneic HSCT are currently being explored in various hematological malignancies including AML. At least for allogeneic HSCT in AML, the optimal dose-intensity of preparative regimens for disease control at an acceptable rate of treatment-related lethal complications has not been determined. The investigators, therefore, evaluated reduced intensity myeloablative conditioning with 8 Gy TBI and fludarabine in AML patients considered ineligible for conventional conditioning in a phase 2 trial (data published in BLOOD by Stelljes et al., 2005). The results suggest that with 8 Gy TBI/fludarabine, conditioning related and unrelated donor transplants can be performed in AML patients in first or second complete remission (CR) with a remarkably low 2-year non relapse mortality (NRM) and satisfactory disease control. Based on these data a randomized phase 3 trial for patients with AML in CR≥2 is currently being conducted by the Cooperative German Transplant Study Group comparing TBI 8 Gy/fludarabine to conventionally dosed conditioning with TBI 12 Gy/cyclophosphamide.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with AML in second complete remission\n* HLA-identical related (HLA \\* A, B, and DR) or HLA-compatible unrelated donor with maximum of one Ag mismatch\n* Ages 18-60 years\n* Written informed consent from the patient\n* Written informed consent from the donor\n* No major organ dysfunction\n\nExclusion Criteria:\n\n* Cardiac failure (New York Heart Association \\[NYHA\\] grade II-IV)\n* Renal failure (creatinine \\> 2.0 mg/dl)\n* Hepatic failure (total bilirubin \\> 3 mg/dl)\n* Severe neurological/psychiatric disorder\n* Previous allogeneic HSCT\n* Contra-indications for used drugs\n* HIV infection\n* Non-compliance to processing of personal data according to the protocol'}, 'identificationModule': {'nctId': 'NCT00125606', 'briefTitle': 'Phase 3 Trial for AML Patients in CR2 Comparing 8Gy TBI /Fludarabine to Conditioning With TBI 12Gy/Cyclophosphamide', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Muenster'}, 'officialTitle': 'Randomized Phase 3 Trial for Patients With AML in CR2 Comparing Total Body Irradiation (TBI) With 8Gy/Fludarabine to Conditioning With TBI 12Gy/Cyclophosphamide', 'orgStudyIdInfo': {'id': 'AML_CR2_allo_HSCT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'conditioning therapy with 12 Gy TBI / cyclophosphamide 120', 'interventionNames': ['Procedure: conditioning for allogeneic HSCT']}, {'type': 'EXPERIMENTAL', 'label': 'conditioning therapy with 8 Gy TBI / fludarabine 120', 'interventionNames': ['Procedure: conditioning for allogeneic HSCT']}], 'interventions': [{'name': 'conditioning for allogeneic HSCT', 'type': 'PROCEDURE', 'armGroupLabels': ['conditioning therapy with 12 Gy TBI / cyclophosphamide 120', 'conditioning therapy with 8 Gy TBI / fludarabine 120']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48149', 'city': 'Münster', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Department of Medicine/Hematology and Oncology', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}], 'overallOfficials': [{'name': 'Matthias Stelljes, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Medicine/Hematology and Oncology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Muenster', 'class': 'OTHER'}, 'collaborators': [{'name': 'Technische Universität Dresden', 'class': 'OTHER'}, {'name': 'Philipps University Marburg', 'class': 'OTHER'}, {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, {'name': 'Hannover Medical School', 'class': 'OTHER'}, {'name': 'Ludwig-Maximilians - University of Munich', 'class': 'OTHER'}, {'name': 'University Hospital, Essen', 'class': 'OTHER'}, {'name': 'Johann Wolfgang Goethe University Hospital', 'class': 'OTHER'}, {'name': 'Deutsche Klinik fuer Diagnostik', 'class': 'OTHER'}, {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}