Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-29 @ 5:01 PM
Study NCT ID:
NCT01622556
Status:
TERMINATED
Last Update Posted:
2014-02-11
First Post:
2012-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Conditioning Treatment With Umbilical Cord Blood Transplant for Hematologic Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2016-02-12', 'releaseDate': '2016-01-15'}, {'resetDate': '2017-01-13', 'releaseDate': '2016-11-18'}, {'resetDate': '2017-04-04', 'releaseDate': '2017-02-17'}], 'estimatedResultsFirstSubmitDate': '2016-01-15'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D006689', 'term': 'Hodgkin Disease'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D008223', 'term': 'Lymphoma'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C024352', 'term': 'fludarabine'}, {'id': 'D002066', 'term': 'Busulfan'}, {'id': 'C512542', 'term': 'thymoglobulin'}, {'id': 'D014916', 'term': 'Whole-Body Irradiation'}], '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'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2017-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-02-10', 'studyFirstSubmitDate': '2012-06-08', 'studyFirstSubmitQcDate': '2012-06-14', 'lastUpdatePostDateStruct': {'date': '2014-02-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event Free Survival', 'timeFrame': '180 days', 'description': 'Number of subjects surviving with no events at 180 days post transplantation (Day 0).'}], 'secondaryOutcomes': [{'measure': 'Transplant Engraftment', 'timeFrame': 'Day 42', 'description': 'Number of patients with successful UCB engraftment.'}, {'measure': 'Incidence of Graft-versus-host disease (GVHD)', 'timeFrame': '1 year', 'description': 'Number of patients that experience acute or chronic GVHD.'}, {'measure': 'Time course for peripheral blood chimerism.', 'timeFrame': '56 days', 'description': 'Percent of patients with \\>95% donor chimerism.'}, {'measure': 'Incidence of secondary lymphoproliferative diseases', 'timeFrame': '6 months', 'description': 'Number of patients with secondary lymphoproliferative diseases.'}, {'measure': 'Incidence of disease recurrence', 'timeFrame': 'Up to two years', 'description': 'Number of patients experience disease recurrence.'}, {'measure': 'Incidence of serious infectious complications', 'timeFrame': '1 year', 'description': 'Number of patients experiencing serious infectious complications.'}, {'measure': 'Overall Survivals', 'timeFrame': '60 months', 'description': 'Number of patient with overall event free survival and overall survival distributions.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chronic Myeloid Leukemia', 'Acute Myeloid Leukemia', 'Acute Lymphoblastic Leukemia', 'Non-Hodgkins Lymphoma', "Hodgkin's Disease", 'Myelodysplastic Syndromes', 'Myeloproliferative Disorder'], 'conditions': ['Hematologic Malignancies']}, 'descriptionModule': {'briefSummary': 'This is a phase II study to assess the day 180 event free and overall survival after administration of a specified combination of fludarabine, busulfan, Total Body Irradiation (TBI), and thymoglobulin reduced intensity conditioning and 2 unit UCB stem cell transplant in a single institution setting in patients with hematologic malignancies for whom allogeneic transplantation is indicated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nSubjects 18-70 years old. ECOG 0-2\n\nPatients must have a diagnosis of one of the following:\n\n* Chronic Myeloid Leukemia\n* Acute Myeloid Leukemia\n* Acute Lymphoblastic Leukemia\n* Hodgkin's Disease\n* Non-Hodgkins Lymphoma\n* Myelodysplastic Syndromes\n* Myeloproliferative Disorder\n\nPatients must have adequate visceral organ function\n\n* Patients must furnish written informed consent and HIPAA authorization for release of personal health information.\n* Patients must be able to understand the requirements of the study, abide by the study restrictions, and agree to return for the required assessments.\n\nExclusion Criteria:\n\n* Patients who have a histocompatible sibling-matched donor age 18 to 65 years in good health who is willing to donate stem cells are ineligible.\n* Patients who are pregnant are ineligible.\n* Patients are ineligible if they have received cumulative chemotherapy doses in excess of: carmustine (BCNU) 400 mg/m2, and/or a cumulative anthracycline exposure in excess of 550 mg/m2 doxorubicin (Adriamycin®) unless gated-pool radionuclide cardiac scan shows greater than/equal to 45% ejection fraction.\n\nPatients who are HIV or HTLV-I, -II antibody sero-positive are ineligible."}, 'identificationModule': {'nctId': 'NCT01622556', 'briefTitle': 'Conditioning Treatment With Umbilical Cord Blood Transplant for Hematologic Malignancies', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Phase II Trial of Reduced Intensity Conditioning (RIC) and Allogeneic Transplantation of Umbilical Cord Blood (UCB) From Unrelated Donors in Patients With Hematologic Malignancies', 'orgStudyIdInfo': {'id': '15954 UCB-2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Reduced Intensity Conditioning with UCB Transplant', 'interventionNames': ['Drug: Fludarabine', 'Drug: Busulfan', 'Drug: Thymoglobulin', 'Radiation: Total Body Irradiation', 'Biological: Umbilical Cord Blood']}], 'interventions': [{'name': 'Fludarabine', 'type': 'DRUG', 'description': '35 mg/m2 IV/day x 5 days', 'armGroupLabels': ['Reduced Intensity Conditioning with UCB Transplant']}, {'name': 'Busulfan', 'type': 'DRUG', 'description': '.8 mg/kg IV Q6h x 8 doses', 'armGroupLabels': ['Reduced Intensity Conditioning with UCB Transplant']}, {'name': 'Thymoglobulin', 'type': 'DRUG', 'description': '1.5 mg/kg/day x 3 days', 'armGroupLabels': ['Reduced Intensity Conditioning with UCB Transplant']}, {'name': 'Total Body Irradiation', 'type': 'RADIATION', 'description': '150 cGy for 2 days', 'armGroupLabels': ['Reduced Intensity Conditioning with UCB Transplant']}, {'name': 'Umbilical Cord Blood', 'type': 'BIOLOGICAL', 'description': 'Two partially HLA-matched UCB units. Each unit must match at a minimum of 4 of 6 at HLA-A, -B, -DRB1 loci with the recipient.', 'armGroupLabels': ['Reduced Intensity Conditioning with UCB Transplant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'overallOfficials': [{'name': 'Amer M Beitinjaneh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine, Medical Director Stem Cell Transplant Unit', 'investigatorFullName': 'Amer Beitinjaneh, MD', 'investigatorAffiliation': 'University of Virginia'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-01-15', 'type': 'RELEASE'}, {'date': '2016-02-12', 'type': 'RESET'}, {'date': '2016-11-18', 'type': 'RELEASE'}, {'date': '2017-01-13', 'type': 'RESET'}, {'date': '2017-02-17', 'type': 'RELEASE'}, {'date': '2017-04-04', 'type': 'RESET'}], 'unpostedResponsibleParty': 'University of Virginia'}}}}