Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-05-02 @ 11:45 AM
Study NCT ID:
NCT01854567
Status:
COMPLETED
Last Update Posted:
2020-06-26
First Post:
2013-05-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
P3 Study of Umbilical Cord Blood Cells Expanded With MPCs for Transplantation in Patients With Hematologic Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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': 'D007938', 'term': 'Leukemia'}, {'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2017-05-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-25', 'studyFirstSubmitDate': '2013-05-13', 'studyFirstSubmitQcDate': '2013-05-14', 'lastUpdatePostDateStruct': {'date': '2020-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-05-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence and severity of acute Graft Versus Host Disease', 'timeFrame': '100 days'}], 'primaryOutcomes': [{'measure': 'Time to Neutrophil and Platelet Engraftment', 'timeFrame': '100 days'}], 'secondaryOutcomes': [{'measure': 'Proportion of subjects with neutrophil recovery at day 26, platelet recovery at day 60 and subjects alive at day 100', 'timeFrame': '100 days'}, {'measure': 'Percentage of patients with primary graft failure', 'timeFrame': '100 days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cord Blood', 'Stem Cells', 'MPC', 'Mesoblast', 'Expanded', 'AML', 'ALL', 'NHL', 'Leukemia', 'Lymphoma'], 'conditions': ['Acute Myelogenous Leukemia', 'Acute Lymphoblastic Leukemia', "Non-Hodgkin's Lymphoma", "Hodgkin's Disease"]}, 'descriptionModule': {'briefSummary': 'The study investigates the time to engraftment of a mesenchymal expanded cord blood unit in patients with hematologic malignancies undergoing transplantation with myeloablative conditioning.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient must have one of the following:\n\n * Acute myelogenous leukemia (AML) in complete morphological remission at study screening (Complete Remission with Incomplete Platelet Recovery (CRp) acceptable).\n * Acute lymphoblastic leukemia (ALL) in complete morphological remission at study screening (Complete Remission with Incomplete Platelet Recovery (CRp) acceptable).\n * Non-Hodgkin's lymphoma (NHL): High risk subjects with responsive disease after first relapse. High risk includes those with Burkitt's Lymphoma and those with extensive marrow involvement at diagnosis-precluding autologous transplant.\n * Hodgkin's disease: High risk subjects with responsive disease after first relapse.\n* Minimum Karnofsky Scale\n* Subject must weigh at least 20 kg\n* Up to 65 years of age\n* Adequate major organ system function\n\nExclusion Criteria:\n\n* Pregnancy and/or lactating\n* Suitable, 6/6 HLA matched related sibling donor available\n* Previous participation in a stem cell study within last 30 days"}, 'identificationModule': {'nctId': 'NCT01854567', 'briefTitle': 'P3 Study of Umbilical Cord Blood Cells Expanded With MPCs for Transplantation in Patients With Hematologic Malignancies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mesoblast, Ltd.'}, 'officialTitle': 'A 1-Year, Multicenter, Randomized, Open-Label Controlled Study to Evaluate the Efficacy and Safety of Cord Blood Cells Expanded With MPCs for Hematopoetic Recovery in Patients With Hematologic Malignancies After Myeloablative Treatment', 'orgStudyIdInfo': {'id': 'CB-AB006'}, 'secondaryIdInfos': [{'id': '2012-0166', 'type': 'OTHER', 'domain': 'UT MDACC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active', 'description': 'Infusion of one MPC expanded cord unit and one unexpanded cord unit.', 'interventionNames': ['Biological: Infusion of one MPC expanded cord unit and one unexpanded cord unit']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Infusion of two unexpanded cord blood units.', 'interventionNames': ['Biological: Infusion of two unexpanded cord blood units.']}], 'interventions': [{'name': 'Infusion of one MPC expanded cord unit and one unexpanded cord unit', 'type': 'BIOLOGICAL', 'description': 'Infusion of one MPC expanded cord unit and one unexpanded cord unit.', 'armGroupLabels': ['Active']}, {'name': 'Infusion of two unexpanded cord blood units.', 'type': 'BIOLOGICAL', 'description': 'Umbilical Cord Blood.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami Health System Sylvester Comprehensive Cancer Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell-New York Presbyterian Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10595', 'city': 'Valhalla', 'state': 'New York', 'country': 'United States', 'facility': 'Westchester Medical Center', 'geoPoint': {'lat': 41.07482, 'lon': -73.77513}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Case Western', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Transplant Center at Methodist Healthcare System', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Donna Skerrett, MD, MS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mesoblast, Ltd.'}, {'name': 'Elizabeth J. Shpall, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mesoblast, Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}