Ignite Creation Date:
2025-12-24 @ 5:42 PM
Ignite Modification Date:
2025-12-29 @ 3:02 AM
Study NCT ID:
NCT00815568
Status:
UNKNOWN
Last Update Posted:
2008-12-30
First Post:
2008-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility and Efficacy Study of Conditioning Regimen for Allogeneic Hematopoietic Cell Transplantation (HCT) With Fludarabine, Busulfan, and Total Body Irradiation (TBI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C042382', 'term': 'fludarabine phosphate'}, {'id': 'D002066', 'term': 'Busulfan'}, {'id': 'C024352', 'term': 'fludarabine'}], 'ancestors': [{'id': 'D002072', 'term': 'Butylene Glycols'}, {'id': 'D006018', 'term': 'Glycols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D008698', 'term': 'Mesylates'}, {'id': 'D000476', 'term': 'Alkanesulfonates'}, {'id': 'D017738', 'term': 'Alkanesulfonic Acids'}, {'id': 'D000473', 'term': 'Alkanes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 114}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-12', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-12-29', 'studyFirstSubmitDate': '2008-12-29', 'studyFirstSubmitQcDate': '2008-12-29', 'lastUpdatePostDateStruct': {'date': '2008-12-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'progression free survival', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'relapse of primary disease, overall survival, and occurrence of acute/chronic GVHD', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['fludarabine', 'busulfan', 'total body irradiation', 'conditioning regimen'], 'conditions': ['AML', 'MDS', 'ALL', 'CML', 'Lymphoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the OS, RFS, and TRM after HCT with low-dose total body irradiation, fludarabine, and busulfan conditioning.', 'detailedDescription': 'Conventional allogeneic hematopoietic cell transplantation (HCT) for patients with hematological malignancies involves conditioning with high doses of systemic chemo/radiation therapy such as cyclophosphamide (CY) plus 1200 or 1000 cGy total body irradiation (TBI; CY/TBI) or busulfan (Bu) / CY (BuCy). Unfortunately, such regimens have been associated with significant toxicities, limiting their use to otherwise healthy, relatively young patients.\n\nRecently, Fludarabine plus 4 day dose of busulfan (FluBu4) containing myeloablative regimen has been introduced successfully without increasing transplant-related mortality (TRM). To improve transplant outcomes without increasing the risk of recurrence, Russell et al introduced 400cGy of TBI with antithymocyte (ATG, 4.5mg/Kg) into FluBu4 regimen with successful outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 15 years old and not more than 65 years old.\n* ECOG performance status 0-2.\n* Patients with AML or MDS with intermediate/unfavorable cytogenetics.\n* Patients with ALL and CML ineligible for Cy/TBI conditioning.\n* Patients with NHL or HD eligible to myeloablative HCT.\n* Patients receiving unrelated BMT for AML, MDS, ALL, CML, NHL or HD.\n* Consent form signed and dated prior to study specific procedures.\n* Subject able to comply with the scheduled follow-up and with the management of toxicities.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT00815568', 'briefTitle': 'Feasibility and Efficacy Study of Conditioning Regimen for Allogeneic Hematopoietic Cell Transplantation (HCT) With Fludarabine, Busulfan, and Total Body Irradiation (TBI)', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Prospective Phase II Clinical Trial of Myeloablative Conditioning Regimen With Fludarabine and Busulfan Plus 400 cGy Total Body Irradiation for Hematologic Malignancies', 'orgStudyIdInfo': {'id': '2008-07-020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Regimen', 'description': 'Conditioning regimen for AML with FLT3 mutation, AML/MDS unfavorable cytogenetic risk group, chemorefractory NHL or HD, or ALL/CML', 'interventionNames': ['Drug: fludarabine phosphate, busulfan']}], 'interventions': [{'name': 'fludarabine phosphate, busulfan', 'type': 'DRUG', 'otherNames': ['Fludarabine (Fludara®, Berlex Laboratories, Richmond, CA)'], 'description': 'Fludarabine ( 30mg/m2, iv, D-7\\~D-2) Busulfan (3.2mg/kg, iv, D-6\\~D-3) Total body irradiation (200cGy/day, D-2,-1)', 'armGroupLabels': ['Regimen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-710', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Dong Hwan Kim', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Dong Hwan Kim', 'role': 'CONTACT', 'email': 'drkiim@medimail.co.kr', 'phone': '+82-2-3410-1768'}], 'overallOfficials': [{'name': 'Dong Hwan Kim', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dong Hwan Kim', 'oldOrganization': 'Dept of Hematology/Medical Oncology, Samsung Medical Center'}}}}