Ignite Creation Date:
2025-12-24 @ 3:41 PM
Ignite Modification Date:
2026-02-28 @ 6:49 PM
Study NCT ID:
NCT06845592
Status:
RECRUITING
Last Update Posted:
2025-03-04
First Post:
2025-02-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safely Delivered Targeted High-dose Irradiation Followed by Adoptive Immunotherapy with Regulatory and Conventional T Cells to Increase Potency of Hematopoietic Stem Cell Transplantation in High-risk Acute Leukemia
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': 'D012008', 'term': 'Recurrence'}], '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'}, {'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': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015182', 'term': 'Lymphatic Irradiation'}], 'ancestors': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': "A Simon's Minimax two-stage design has been chosen for predicting number of patients and duration of the study. Such design allows the investigator to early stop patient enrollment in case of unexpected futility."}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 51}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2031-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-01', 'studyFirstSubmitDate': '2025-02-14', 'studyFirstSubmitQcDate': '2025-02-19', 'lastUpdatePostDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants free from disease 2 years after HSCT', 'timeFrame': '2 years', 'description': 'The primary objective of the study is to reduce the incidence of disease relapse after irradiation-based conditioning regimen and Treg/Tcon adoptive immunotherapy-based allogeneic transplantation from HLA-matched or haploidentical donors in high-risk acute leukemia patients.'}], 'secondaryOutcomes': [{'measure': 'Number of participants that have reached engraftment 45 days after HSCT', 'timeFrame': '45 days', 'description': 'The study will also evaluate the impact of the allogeneic transplantation from HLA-matched or haploidentical donors with irradiation-based conditioning regimen and Treg/Tcon adoptive immunotherapy on major transplantation outcomes in high-risk acute leukemia patients such as full donor type engraftment.'}, {'measure': 'Number of participants that developed grade ≥ 2 acute GvHD', 'timeFrame': '2 years', 'description': 'The study will also evaluate the impact of the allogeneic transplantation from HLA-matched or haploidentical donors with irradiation-based conditioning regimen and Treg/Tcon adoptive immunotherapy on major transplantation outcomes in high-risk acute leukemia patients such as grade ≥ 2 acute GvHD.'}, {'measure': 'Number of participants free from chronic GvHD 2 years after HSCT', 'timeFrame': '2 years', 'description': 'The study will also evaluate the impact of the allogeneic transplantation from HLA-matched or haploidentical donors with irradiation-based conditioning regimen and Treg/Tcon adoptive immunotherapy on major transplantation outcomes in high-risk acute leukemia patients such as chronic GvHD.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['AML', 'ALL', 'SHARP', 'Total marrow/lymphoid irradiation', 'Treg', 'Tcon', 'Relapse'], 'conditions': ['Acute Myeloid Leukaemia (AML)', 'Acute Lymphoblastic Leukemia ALL', 'High Risk Leukaemia', 'Leukaemia Relapse']}, 'referencesModule': {'references': [{'pmid': '30744963', 'type': 'BACKGROUND', 'citation': 'Cordonnier C, Einarsdottir S, Cesaro S, Di Blasi R, Mikulska M, Rieger C, de Lavallade H, Gallo G, Lehrnbecher T, Engelhard D, Ljungman P; European Conference on Infections in Leukaemia group. 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N Engl J Med. 1998 Oct 22;339(17):1186-93. doi: 10.1056/NEJM199810223391702.'}]}, 'descriptionModule': {'briefSummary': 'The study is a monocentric, interventional study that evaluates the efficacy of allogeneic HLA-matched or haploidentical transplantation consisting of an irradiation-based conditioning regimen coupled with donor Treg/Tcon adoptive immunotherapy for high-risk acute leukemia patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* AML patients\n\n * Diagnosis of AML with indication to allogeneic hematopoietic cell transplantation.\n * Diagnosis of adverse genetic risk leukemia or presence of MRD or active disease (bone marrow infiltration 5-30%) at the time of the transplant procedure.\n * Availability of a hematopoietic stem cell donor (family or unrelated HLA-matched or HLA-haploidentical with the patient) suitable to be treated with G-CSF (10 mcg/kg/die) for a maximum of 7 days and able to tolerate 2 or more leukaphereses.\n * Age ≥ 18 and ≤ 65 years\n * ECOG ≤ 2\n * HCT-CI ≤ 4 (51,52)\n * Absence of relevant psychiatric diseases\n * Signature of the informed consent\n\nALL patients\n\n* Diagnosis of ALL, either T or B (Philadelphia negative) or mixed phenotype with indication to allogeneic transplant\n* Presence of MRD or active disease (bone marrow infiltration 5-30%) or patient with ≥ 2nd complete hematologic remission at the time of the transplant procedure.\n* Availability of a hematopoietic stem cell family donor (family or unrelated HLA-matched or HLA-haploidentical with the patient) suitable to be treated with G-CSF (10 mcg/kg/die) for a maximum of 7 days and able to tolerate 2 or more leukaphereses.\n* Age ≥ 18 and ≤ 65 years\n* ECOG ≤ 2\n* HCT-CI ≤ 4\n* Absence of relevant psychiatric diseases\n* Signature of the informed consent\n\nExclusion Criteria:\n\n* AML patients\n\n * AML in CR MRD-\n * AML with \\> 5% peripheral blasts or bone marrow infiltration ≥ 30%\n * Age \\< 18 years or \\> 65 years\n * ECOG \\> 2\n * Unacceptable lung, liver, kidney, and/or heart function and presence of relevant psychiatric diseases according to clinical judgment\n * Pregnancy\n * No signature of the informed consent\n* ALL patients\n\n * ALL with \\> 5% peripheral blasts or bone marrow infiltration ≥30%\n * Philadelphia positive ALL\n * Age \\< 18 years or \\> 65 years\n * ECOG \\> 2\n * Unacceptable lung, liver, kidney, and/or heart function and presence of relevant psychiatric diseases according to clinical judgment\n * Pregnancy\n * No signature of the informed consent'}, 'identificationModule': {'nctId': 'NCT06845592', 'acronym': 'SHARP', 'briefTitle': 'Safely Delivered Targeted High-dose Irradiation Followed by Adoptive Immunotherapy with Regulatory and Conventional T Cells to Increase Potency of Hematopoietic Stem Cell Transplantation in High-risk Acute Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'University Of Perugia'}, 'officialTitle': 'SHARP - Safely Delivered Targeted High-dose Irradiation Followed by Adoptive Immunotherapy with Regulatory and Conventional T Cells to Increase Potency of Hematopoietic Stem Cell Transplantation in High-risk Acute Leukemia', 'orgStudyIdInfo': {'id': 'SHARP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TMLI based contioning and Treg/Tcon adoptive immunotherapy in allogeneic cell transplantation', 'description': 'All enrolled patients will receive a 20Gy-TMLI based conditioning regimen followed by the infusion of donor graft and Treg/Tcon adoptive immunotherapy', 'interventionNames': ['Radiation: total marrow/lymphoid irradiation']}], 'interventions': [{'name': 'total marrow/lymphoid irradiation', 'type': 'RADIATION', 'description': 'Combination of 20 Gy TMLI with Treg/Tcon adoptive immunotherapy in allogeneic cell transplantation', 'armGroupLabels': ['TMLI based contioning and Treg/Tcon adoptive immunotherapy in allogeneic cell transplantation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06100', 'city': 'Perugia', 'state': 'PG', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Antonio Pierini, MD, PhD', 'role': 'CONTACT', 'email': 'antonio.pierini@unipg.it', 'phone': '3355477611'}], 'facility': 'Università degli Studi di Perugia', 'geoPoint': {'lat': 43.1122, 'lon': 12.38878}}], 'centralContacts': [{'name': 'Antonio Pierini', 'role': 'CONTACT', 'email': 'antonio.pierini@unipg.it', 'phone': '+393355477611', 'phoneExt': '+39'}, {'name': 'Loredana Ruggeri', 'role': 'CONTACT', 'email': 'loredana.ruggeri@ospedale.perugia.it', 'phone': '+393388953982', 'phoneExt': '+39'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Of Perugia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Antonio Pierini', 'investigatorAffiliation': 'University Of Perugia'}}}}