Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:28 PM
Study NCT ID:
NCT00858793
Status:
TERMINATED
Last Update Posted:
2022-09-08
First Post:
2009-03-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
High-dose Chemotherapy With Transplantation of Gene-modified Haematopoietic Stem Cells for HIV-positive Patients With Malignant Diseases Indicating an HSCT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016483', 'term': 'Lymphoma, AIDS-Related'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'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'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005796', 'term': 'Genes'}], 'ancestors': [{'id': 'D040481', 'term': 'Genome Components'}, {'id': 'D016678', 'term': 'Genome'}, {'id': 'D040342', 'term': 'Genetic Structures'}, {'id': 'D055614', 'term': 'Genetic Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'A leukaemia case was reported in patient treated with a similar vector. For safety risk we stopped recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-11-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2016-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-04', 'studyFirstSubmitDate': '2009-03-09', 'studyFirstSubmitQcDate': '2009-03-09', 'lastUpdatePostDateStruct': {'date': '2022-09-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events, ECOG performance status and laboratory safety tests', 'timeFrame': 'five years after transplantation'}], 'secondaryOutcomes': [{'measure': 'Remission status (CR or PR)', 'timeFrame': 'five years after transplantation'}, {'measure': 'Any relapse of ARL', 'timeFrame': 'five years after transplantation'}, {'measure': 'level and kinetics of engraftment and level of gene marking', 'timeFrame': 'five years after transplantation'}, {'measure': 'Viral load', 'timeFrame': 'five years after transplantation'}, {'measure': 'CD4 counts', 'timeFrame': 'five years after transplantation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['AIDS', 'HIV', 'Lymphoma', 'Stem Cell Transplantation', 'gene-modified Stem Cells', 'treatment experienced'], 'conditions': ['AIDS-related Lymphoma', 'HIV Infections']}, 'referencesModule': {'references': [{'pmid': '21289631', 'type': 'RESULT', 'citation': 'Yla-Herttuala S. Gene therapy moves forward in 2010. Mol Ther. 2011 Feb;19(2):219-20. doi: 10.1038/mt.2010.307. No abstract available.'}], 'seeAlsoLinks': [{'url': 'https://www.esgct.eu/home/Previous%20Congresses/2010_Milan/Milan_2010_abstracts.pdf', 'label': 'page 1435; abstract 109'}]}, 'descriptionModule': {'briefSummary': 'Patient stem cells will be mobilized with induction chemotherapy (R)-ICE and G-CSF. If sufficient cells can be mobilized, patients will be treated with high-dose chemotherapy and a transplant of autologous CD34+ cells transduced with an antiviral vector (M87o). If autologous CD34+ yield is insufficient, allogeneic gene-modified cells will be given, if a compatible donor is available. To minimize risk of transplant failure, a second unmodified CD34+ cell transplant will be given one week after the first transplant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients of any ethnic group aged between 18 and 65 years\n* HIV-positive patients with malignant diseases of the blood (NHL, Hodgkin disease, plasmocytoma, acute and chronic leukaemia) who failed to achieve complete remission (CR) after standard-dose first-line chemotherapy or had a chemosensitive relapse after an initial CR\n* Patients must receive HAART\n\nExclusion Criteria:\n\n* Any of the following conditions:\n\n * congestive heart failure (NYHA \\> II)\n * documented EBV, HBV or HCV infection (only for allogeneic PBSCT)\n * creatinine clearance \\< 60 ml/min\n * left ventricular ejection fraction \\< 40%\n * bilirubin \\> 2 mg/dl\n* Severe opportunistic infection\n* More than 10% of bone marrow involved with lymphoma\n* Between 2 and 5 10\\^6 autologous CD34+ cells/kg BW obtained after leukapheresis and CD34 enrichment\n* Women of child.bearing potential not under adequate contraceptive protection\n* Women who are pregnant or breast feeding\n* Known history of drug-, medication- or alcohol abuse within the last 12 months preceding the study\n* Participation in another study with an investigational product within less than one month prior to this study\n* Simultaneous participation in a study with an investigational drug\n* Presence of any disease likely to require procedures altering the schedule of the protocol\n* Patients with a history of seizures, central nervous system disorders or psychiatric disability thought to be clinically significant in the opinion of the investigator\n* Patients with limited mental capacity to the extent that he/she cannot provide informed consent or information regarding adverse events of the study medication\n* Patients with any clinically meaningful renal, hepatic, respiratory or cardiovascular disease\n* Patients who have previously been admitted to this study\n* Patients who will not accept transfusions of blood products'}, 'identificationModule': {'nctId': 'NCT00858793', 'briefTitle': 'High-dose Chemotherapy With Transplantation of Gene-modified Haematopoietic Stem Cells for HIV-positive Patients With Malignant Diseases Indicating an HSCT', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': 'High-dose Chemotherapy With Transplantation of Gene-modified Haematopoietic Stem Cells for HIV-positive Patients With Malignant Diseases Indicating an HSCT', 'orgStudyIdInfo': {'id': 'ARL-GT 2005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'interventionNames': ['Procedure: PBSC-M87o, Gene (M87o)-modified, CD34+ peripheral blood progenitor cells (PBSC)']}], 'interventions': [{'name': 'PBSC-M87o, Gene (M87o)-modified, CD34+ peripheral blood progenitor cells (PBSC)', 'type': 'PROCEDURE', 'description': 'Patient stem cells will be mobilized with induction chemotherapy (R)-ICE and G-CSF. If sufficient cells can be mobilized, patients will be treated with high-dose chemotherapy and a transplant of autologous CD34+ cells transduced with an antiviral vector (M87o). If autologous CD34+ yield is insufficient, allogeneic gene-modified cells will be given, if a compatible donor is available. To minimize risk of transplant failure, a second unmodified CD34+ cell transplant will be given one week after the first transplant.', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'University Medical Center Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'overallOfficials': [{'name': 'Nicolaus Kroeger', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Hamburg-Eppendorf, Department for Stem Cell Transplantation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}