Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2025-12-25 @ 11:54 PM
Study NCT ID:
NCT06600568
Status:
RECRUITING
Last Update Posted:
2025-12-08
First Post:
2024-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Novel Therapeutic Approach for Human T-cell Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054218', 'term': 'Precursor T-Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'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': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2024-09-11', 'studyFirstSubmitQcDate': '2024-09-16', 'lastUpdatePostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary outcome', 'timeFrame': 'Through study completion, an average of 2 years', 'description': 'Response of leukemic cells to treatments that remodulate redox state and apoptosis from a molecular point of view, ex vivo,through the development of a multidimensional approach aimed at reducing the chemoresistance of T neoplasms'}], 'secondaryOutcomes': [{'measure': 'Secondary outcome', 'timeFrame': 'Through study completion, an average of 2 years', 'description': 'Development of drug combinations that can selectively eliminate T-cell leukemia/lymphoma cells'}, {'measure': 'Secondary outcome', 'timeFrame': 'Through study completion, an average of 2 years', 'description': 'Analysis of DNA, RNA, protein, and circulating markers of alterations present at baseline in patient samples; profiles obtained will be correlated with response to drug treatments in order to identify biomarkers predictive of response to treatment.'}, {'measure': 'Secondary outcome', 'timeFrame': 'Through study completion, an average of 2 years', 'description': 'Analysis of the efficacy of new drug combinations in vivo through the generation of PDX-based experimental mouse models derived from patients with T-cell malignancies.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['T-cell lymphoblastic leukemias (T-ALL)', "T-cell non-Hodgkin's lymphomas (T-NHL)", 'NK cell neoplasia', 'ROS', 'apoptosis'], 'conditions': ['T-Cell Leukemia/Lymphoma, Adult']}, 'descriptionModule': {'briefSummary': 'This multicenter translational study, with prospective and retrospective samples, aims to identify new strategies to selectively eliminate neoplastic T cells by modulating intracellular ROS levels.\n\nInteractions between drugs capable of activating the apoptotic process (e.g., Venetoclax) and drugs capable of altering ROS homeostasis (e.g., inhibitors of the enzyme glucose-6-phosphate dehydrogenase) will be examined.\n\nThe most promising compounds will be selected based on results obtained in vitro on cell lines and PDX already available in the laboratory, and then will be assayed ex vivo in cells obtained from patients with resistant/refractory T-cell neoplasms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Up to a maximum of 120 patients (both retrospective and prospective) are expected to be enrolled during the study period. Specifically, a maximum of 40 patients will be enrolled for each of the following diseases: T-cell lymphoblastic leukemias (T-ALL); T-cell non-Hodgkin lymphomas (T-NHL); NK-cell neoplasms. For retrospective peripheral blood samples, bone marrow aspirates, and lymph node biopsies, which are available at the centers involved in the study, patients will be contacted again to ask for consent regarding this project.\n\nNo additional clinical procedures are specifically required by participation in the present study. In fact, samples will be obtained from the material left over from samples taken for clinical procedures.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with pre- and post-thymic T-cell leukemia/lymphoma\n* Patients of both sexes\n* Age of patients older than 18 years\n* Patient is willing to provide written and signed informed consent for participation in the study\n\nExclusion Criteria:\n\n-Serious illness or medical condition that does not allow the patient to be managed according to standard treatment protocols, including uncontrolled active infection.'}, 'identificationModule': {'nctId': 'NCT06600568', 'briefTitle': 'Novel Therapeutic Approach for Human T-cell Malignancies', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Oncologico Veneto IRCCS'}, 'officialTitle': 'Identification of Targetable Vulnerabilities in Redox Homeostasis Pathways as a Novel Therapeutic Approach for Human T-cell Malignancies', 'orgStudyIdInfo': {'id': 'ROSinTALL'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Translation analysis', 'type': 'OTHER', 'description': 'Novel strategies to selectively eliminate neoplastic T cells by modulating intracellular ROS levels.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80100', 'city': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Antonio Pinto, MD', 'role': 'CONTACT', 'email': 'a.pinto@istitutotumori.na.it', 'phone': '081/1777-0368'}], 'facility': 'Istituto Nazionale Tumori Fondazione G.Pascale', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '35128', 'city': 'Padua', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Michele Gottardi, MD', 'role': 'CONTACT', 'email': 'michele.gottardi@iov.veneto.it', 'phone': '+39 0423-732336'}], 'facility': 'Istituto Oncologico Veneto', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}], 'centralContacts': [{'name': 'Michele Gottardi, MD', 'role': 'CONTACT', 'email': 'michele.gottardi@iov.veneto.it', 'phone': '+39 0423732336'}, {'name': 'GianLuca De Salvo, MD', 'role': 'CONTACT', 'email': 'gianluca.desalvo@iov.veneto.it', 'phone': '+390498215704'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Oncologico Veneto IRCCS', 'class': 'OTHER'}, 'collaborators': [{'name': 'Istituto Nazionale Tumori IRCSS-Fondazione G.Pascale', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}