Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2025-12-26 @ 3:26 PM
Study NCT ID:
NCT00718250
Status:
UNKNOWN
Last Update Posted:
2008-07-18
First Post:
2008-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lentivirus Transduced Acute Myeloid Leukaemia Blasts Expressing B7.1 (CD80) and IL-2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-07', 'completionDateStruct': {'date': '2012-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-07-16', 'studyFirstSubmitDate': '2008-06-06', 'studyFirstSubmitQcDate': '2008-07-16', 'lastUpdatePostDateStruct': {'date': '2008-07-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Toxicity and safety of the 'AML Cell Vaccine'", 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'relapse, leukaemia free survival and overall survival', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Acute myeloid leukaemia', 'Cancer vaccines', 'Immunotherapy'], 'conditions': ['Leukemia, Myeloid, Acute']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to assess the safety and tolerability of an 'AML Cell Vaccine' in patients with poor prognosis acute myeloid leukaemia (AML)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of AML defined according to the WHO classification\n* Age ≥ 18 years\n* New presentation or relapsed AML\n* Patients must be able to give written informed consent\n* Failure to enter complete morphological remission (\\>5% bone marrow AML cells) or persistence of cytogenetic abnormality following intensive combination chemotherapy At day+100 post-transplant\n* HIV negative\n* No GvHD\n* No continuing use of immunosuppressive drugs\n* Absence of active systemic fungal or viral infection including HTLV-1, hepatitis B or C.\n* Adequate renal and liver function confirmed by: creatinine clearance \\>30mls/min; bilirubin \\<3.0 x upper limit of normal; AST \\<3.0 x upper limit of normal; prothrombin time \\<2.0 x upper limit of normal.\n\nPerformance status of 1 or less by ECOG criteria or \\>80% by the Karnovsky score\n\n* Patient must provide written informed consent and be willing to comply for the duration of the study.\n* Life expectancy \\>36 weeks\n* Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 10 - 14 days and again within 24 hours of starting the study. In addition, sexually active WCBP must agree continued abstinence from heterosexual intercourse or to use adequate contraceptive methods starting 4 weeks prior to the initiation of therapy (see appendix G for pregnancy testing and birth control guidelines while on study). WCBP must agree to have pregnancy tests every 3 weeks while on study drug (every 14 days for women with irregular cycles) and 4 weeks after the last dose of study drug. Men must also agree to use a condom if their partner is of child bearing potential, even if they have had a successful vasectomy.\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* Patients not fit for intensive chemotherapy\n* Complete morphological and cytogenetic remission following intensive combination chemotherapy\n* Absence of HLA compatible donor\n* HIV positive\n* Evidence of graft versus host disease at day+100 post transplant\n* Evidence of relapse of leukaemia (≥5% bone marrow blasts)\n* Concurrent use of other forms of anti-leukaemic therapy\n* Other malignancy with the exception of carcinoma in situ.\n* Significant history of heart disease (unstable angina, myocardial within the past six months, congestive cardiac failure requiring daily treatment)\n* Evidence of active lung disease determined by chest x-ray and absence of chronic lung disease (FEV1\\<60% predicted, Vital capacity \\<60%, Tlco\\<50%)'}, 'identificationModule': {'nctId': 'NCT00718250', 'acronym': 'RFUSIN2-AML1', 'briefTitle': 'Lentivirus Transduced Acute Myeloid Leukaemia Blasts Expressing B7.1 (CD80) and IL-2', 'organization': {'class': 'OTHER', 'fullName': "King's College Hospital NHS Trust"}, 'officialTitle': 'A Phase I Study of Lentivirus Transduced Acute Myeloid Leukaemic Cells (AML) Expressing B7.1 (CD80) and IL-2 for the Potential Enhancement of Graft Versus Leukaemia(GvL) Effect in Poor Prognosis AML', 'orgStudyIdInfo': {'id': 'O5CC14'}, 'secondaryIdInfos': [{'id': 'EudraCT 2005-000806-29'}, {'id': 'GTAC GTAC098'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cohort 1', 'description': 'AML Cell Vaccine alone', 'interventionNames': ['Biological: RFUSIN2-AML1']}, {'type': 'EXPERIMENTAL', 'label': 'cohort 2', 'description': 'Donor leukocytes alone', 'interventionNames': ['Biological: Donor leukocyte infusion (DLI)']}, {'type': 'EXPERIMENTAL', 'label': 'cohort 3', 'description': 'AML cell vaccine and Donor Leukocyte Infusion (1x107/kg)', 'interventionNames': ['Biological: RFUSIN2-AML1 and donor leukocyte infusion']}, {'type': 'EXPERIMENTAL', 'label': 'cohort 4', 'description': 'AML cell vaccine and Donor Leukocyte Infusion (1x108/kg)', 'interventionNames': ['Biological: RFUSIN2-AML1 and donor leukocyte infusion']}], 'interventions': [{'name': 'RFUSIN2-AML1', 'type': 'BIOLOGICAL', 'description': 'AML cell vaccine alone. x4 doses 3 weeks apart', 'armGroupLabels': ['cohort 1']}, {'name': 'Donor leukocyte infusion (DLI)', 'type': 'BIOLOGICAL', 'otherNames': ['RFUSIN2-AML1'], 'description': '1 dose 1x107/kg', 'armGroupLabels': ['cohort 2']}, {'name': 'RFUSIN2-AML1 and donor leukocyte infusion', 'type': 'BIOLOGICAL', 'otherNames': ['RFUSIN2-AML1'], 'description': 'AML cell vaccine x 4 doses 3 weeks apart Donor leukocyte infusion 1x107/kg x 1 dose', 'armGroupLabels': ['cohort 3']}, {'name': 'RFUSIN2-AML1 and donor leukocyte infusion', 'type': 'BIOLOGICAL', 'otherNames': ['RFUSIN2-AML1'], 'description': 'AML cell vaccine x4 doses 3 weeks apart Donor leukocyte infusion 1x108/kg x1 dose', 'armGroupLabels': ['cohort 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE5 9RS', 'city': 'London', 'state': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': "King's College Hospital NHS Foundation Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Ghulam J Mufti', 'role': 'CONTACT', 'email': 'ghulam.mufti@kcl.ac.uk', 'phone': '+44 2032999000', 'phoneExt': '3080'}, {'name': 'Wendy Ingram', 'role': 'CONTACT', 'email': 'wendy.ingram@kch.nhs.uk', 'phone': '+44 2032999000', 'phoneExt': '4642'}], 'overallOfficials': [{'name': 'Ghulam J Mufti', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "King's College London, London, United Kingdom"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "King's College Hospital NHS Trust", 'class': 'OTHER'}, 'collaborators': [{'name': 'Department of Health', 'class': 'AMBIG'}, {'name': 'Leukemia Research Fund', 'class': 'OTHER'}, {'name': 'Elimination of Leukaemia Fund', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Dr Lorraine Catt, Research and Development Manager', 'oldOrganization': "King's College Hospital NHS Foundation Trust, London, United Kingdom"}}}}