Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2025-12-30 @ 5:22 AM
Study NCT ID:
NCT01613066
Status:
UNKNOWN
Last Update Posted:
2012-06-06
First Post:
2012-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intra-bone Cord Blood Transplantation in Patients With Haematological Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2013-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-06-05', 'studyFirstSubmitDate': '2012-06-04', 'studyFirstSubmitQcDate': '2012-06-05', 'lastUpdatePostDateStruct': {'date': '2012-06-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to neutrophil recovery', 'timeFrame': '28 days after transplantation'}], 'secondaryOutcomes': [{'measure': 'Incidence of platelet engraftment', 'timeFrame': '100 days after transplantation'}, {'measure': 'Acute graft versus host disease', 'timeFrame': '100 days after transplantation'}, {'measure': 'Chronic Graft Versus Host Disease', 'timeFrame': 'One year after transplantation'}, {'measure': 'Overall Survival', 'timeFrame': 'One year after transplantation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Haematological malignancies', 'Allogeneic Cord Blood transplantation', 'Intrabone'], 'conditions': ['High Risk Haematological Malignancies', 'Advanced Haematological Malignancies']}, 'referencesModule': {'references': [{'pmid': '18693069', 'type': 'BACKGROUND', 'citation': 'Frassoni F, Gualandi F, Podesta M, Raiola AM, Ibatici A, Piaggio G, Sessarego M, Sessarego N, Gobbi M, Sacchi N, Labopin M, Bacigalupo A. Direct intrabone transplant of unrelated cord-blood cells in acute leukaemia: a phase I/II study. Lancet Oncol. 2008 Sep;9(9):831-9. doi: 10.1016/S1470-2045(08)70180-3. Epub 2008 Aug 8.'}, {'pmid': '21277377', 'type': 'BACKGROUND', 'citation': 'Page KM, Zhang L, Mendizabal A, Wease S, Carter S, Gentry T, Balber AE, Kurtzberg J. Total colony-forming units are a strong, independent predictor of neutrophil and platelet engraftment after unrelated umbilical cord blood transplantation: a single-center analysis of 435 cord blood transplants. Biol Blood Marrow Transplant. 2011 Sep;17(9):1362-74. doi: 10.1016/j.bbmt.2011.01.011. Epub 2011 Jan 28.'}]}, 'descriptionModule': {'briefSummary': 'Cord blood (CB) from an unrelated donor is increasingly used an alternative source of hematopoietic stem cells for adults with hematologic malignancies who lack an HLA-matched donor. However, the utilization of single-unit CB for transplantation of adult patients has been impeded by the low number of nucleated cells available from individual CB units. Direct intrabone CB injection (IBCBi) has been recently investigated as a solution to cell dose problem in adults, with the aims of minimizing non-specific loss of progenitors. We set up a phase I-II study to assess the safety and efficacy of CB transplantation by IBCBi in adult patients with advanced or high-risk hematological malignancies'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Advanced or High Risk Haematological Malignancies\n* Age 18-65 years\n* no suitable unrelated HLA-matched donors identified in a clinically useful time-frame\n* Informed consent\n\nExclusion Criteria:\n\n* Active infectious disease at inclusion\n* HIV- positivity or active hepatitis infection\n* Impaired liver function (Bilirubin \\> upper normal limit; Transaminases \\> 3.0 x upper normal limit) at inclusion\n* Impaired renal function (Creatinine-clearance \\<60 ml/min; Serum Creatinine \\>1.5 x upper normal limit) at inclusion\n* Psychiatric diseases or conditions that might impair the ability to give informed consent'}, 'identificationModule': {'nctId': 'NCT01613066', 'briefTitle': 'Intra-bone Cord Blood Transplantation in Patients With Haematological Malignancies', 'organization': {'class': 'OTHER', 'fullName': 'Ospedale Santa Croce-Carle Cuneo'}, 'officialTitle': 'Intra-bone Cord Blood Transplantation in Patients With Haematological Malignancies', 'orgStudyIdInfo': {'id': 'Emato68'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Patients with high risk haematological malignancies', 'interventionNames': ['Procedure: Intrabone Allogeneic Transplant']}], 'interventions': [{'name': 'Intrabone Allogeneic Transplant', 'type': 'PROCEDURE', 'description': 'Unrelated single unit intrabone cord blood transplantation', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12100', 'city': 'Cuneo', 'state': 'Cuneo', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Daniele Mattei, MD', 'role': 'CONTACT', 'email': 'mattei.d@ospedale.cuneo.it', 'phone': '+390171642229'}, {'name': 'Roberto Sorasio, MD', 'role': 'CONTACT', 'email': 'rsorasio@inwind.it', 'phone': '+390171642229'}, {'name': 'Daniele Mattei, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Azienda Ospedaliera S Croce e Carle', 'geoPoint': {'lat': 44.39071, 'lon': 7.54828}}], 'centralContacts': [{'name': 'Roberto Sorasio, Head, MD', 'role': 'CONTACT', 'email': 'rsorasio@inwind.it', 'phone': '+390171642229'}, {'name': 'Daniele Mattei, MD', 'role': 'CONTACT', 'email': 'mattei.d@ospedale.cuneo.it', 'phone': '+390171642229'}], 'overallOfficials': [{'name': 'Daniele Mattei, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ASO S Croce e Carle'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ospedale Santa Croce-Carle Cuneo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Roberto Sorasio', 'investigatorAffiliation': 'Ospedale Santa Croce-Carle Cuneo'}}}}