Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-02-13 @ 5:26 AM
Study NCT ID:
NCT06626893
Status:
RECRUITING
Last Update Posted:
2024-10-04
First Post:
2024-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Integrative "Omics" Approaches for Leukemia Target Identification and Matched Therapeutic Intervention
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'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-02', 'studyFirstSubmitDate': '2024-03-21', 'studyFirstSubmitQcDate': '2024-10-02', 'lastUpdatePostDateStruct': {'date': '2024-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Functional and chemogenomic profiling', 'timeFrame': '24 months', 'description': 'Dose-response curves for each drug tested, genetic profile for NGS analyses, description of vesicles contents'}], 'primaryOutcomes': [{'measure': 'Frequencies of alternative therapies identified for AL patients', 'timeFrame': '12 months', 'description': 'Number of patients treated with alternative therapies'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myeloid Leukemia, Acute', 'Leukemia, Acute Lymphoblastic']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to use multiple "omics" sciences to more thoroughly investigate Acute Recurrent/Refractory Leukemias (LA R/R) after conventional therapy in order to identify new targets and/or therapeutic approaches, in patients with a diagnosis of Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia/ Lymphoblastic Lymphoma B(ALL-B), Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma T (ALL-T), Acute Biphenotypic Leukemia/II as defined by WHO( World Health Organization) 2016, relapsed or refractory after at least one line of therapy. The main question that the trial aims to answer is: "Can molecules with known biological activity be active and represent possible new therapeutic strategies in relapsed/refractory Acute Leukemias on the basis of response profiles identified through the integration of next-generation chemogenomic and functional analyses? " It is expected that a minimum of 100 patients, male and female, aged 18 years and older, will be included. To participate in the study, the patient must consent to the performance on biological specimen (peripheral blood and bone marrow) of genetic/molecular and/or "omics" investigations performed with modern sequencing techniques, such as Next Generation Sequencing, Single Cell RNA Seq (scRNAseq), RT-qPCR(Quantitative reverse transcription polymerase chain reaction). These investigations will aim to improve the understanding of the genetic and molecular alterations of her disease. In addition, your cells will be used in the laboratory to perform in vitro sensitivity studies (drug response profiling - DRP) that aim to simultaneously test a set of hundreds of drugs to assess sensitivity or resistance profiles of your disease cells with the aim of identifying specific new therapies that target specific cellular mechanisms. In addition, part of the biological sample will be used for investigations of the bone marrow microenvironment and the "secretome", i.e., cell signaling molecules and methods. In order to accomplish this study, samples from peripheral or bone marrow blood taken during routine investigations performed during follow-up and re-evaluation visits for the patient\'s disease as per normal clinical practice will be used. Among the investigations that will be performed on the blood sample will be the genetic/molecular and/or omics and preclinical investigations described above.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients to be enrolled in the study must have a diagnosis of AML, B ALL/LBL, T ALL/LBL, MPAL/AUL as described by WHO 2016 classification and must complained relapsed or refractory disease after at least one line of therapy\n* Ages Eligible for Study: over 18years\n* Patients must have greater than 5% blasts in the bone marrow with or without extramedullary disease\n* Patients with must have recurrent disease, documented by clinical or radiographic criteria, as well as histologic verification of the malignancy at original diagnosis\n* Patients may be enrolled on study regardless of the timing of prior I therapy\n* Patients must be capable of understanding the investigational nature and the objectives of the study. All patients must sign a written informed consent.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06626893', 'acronym': 'AL-TOMICA', 'briefTitle': 'Integrative "Omics" Approaches for Leukemia Target Identification and Matched Therapeutic Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliero-Universitaria di Parma'}, 'officialTitle': 'Integrative "Omics" Approaches for Leukemia Target Identification and Matched Therapeutic Intervention', 'orgStudyIdInfo': {'id': '3070'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Relapsed Refractory Acute Leukemias', 'description': 'Functional and genomics analyses will be performed on primary sample from each enrolled patient (biological preclinical study)', 'interventionNames': ['Biological: Functional tests', 'Genetic: Next Generation Sequencing analysis', 'Biological: Microvesicles analysis']}], 'interventions': [{'name': 'Functional tests', 'type': 'BIOLOGICAL', 'description': 'Functional analyses will be performed on primary sample from each enrolled patient. Isolated blast cells are cultered and incubated with a specific library of drugs (175 drugs) at four different concentrations for 72 hours.', 'armGroupLabels': ['Relapsed Refractory Acute Leukemias']}, {'name': 'Next Generation Sequencing analysis', 'type': 'GENETIC', 'description': 'For each patient, sequencing analyses will be performed on blast cells (for somatic mutations) and on epithelial cells from buccal swab (for germline mutations)', 'armGroupLabels': ['Relapsed Refractory Acute Leukemias']}, {'name': 'Microvesicles analysis', 'type': 'BIOLOGICAL', 'description': 'Analyses on microvesicles isolated from both Bone Marrow samples and Peripheral Blood Samples will be performed to investigate the microenvironment of the disease.', 'armGroupLabels': ['Relapsed Refractory Acute Leukemias']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47014', 'city': 'Meldola', 'state': 'Forlì-Cesena', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giovanni Martinelli, MD', 'role': 'CONTACT', 'phone': '0543 1931094'}], 'facility': 'IRST-IRCCS Meldola', 'geoPoint': {'lat': 44.12775, 'lon': 12.0626}}, {'zip': '40138', 'city': 'Bologna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Antonio Curti, MD', 'role': 'CONTACT', 'phone': '051 2143680'}], 'facility': 'A.O.U. Bologna', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '44124', 'city': 'Ferrara', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Antonio Cuneo, MD', 'role': 'CONTACT', 'phone': '0532 236978'}], 'facility': 'A.O.U. Ferrara', 'geoPoint': {'lat': 44.83804, 'lon': 11.62057}}, {'zip': '43126', 'city': 'Parma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Benedetta Cambò, PHD', 'role': 'CONTACT', 'email': 'bcambo@ao.pr.it', 'phone': '0521 704446'}], 'facility': 'AOU Parma', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}, {'zip': '29121', 'city': 'Piacenza', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Daniele Vallisa, MD', 'role': 'CONTACT', 'phone': '0523 302242'}], 'facility': 'Piacenza Hospital - AUSL Piacenza', 'geoPoint': {'lat': 45.05242, 'lon': 9.69342}}, {'zip': '48121', 'city': 'Ravenna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Francesco Lanza, MD', 'role': 'CONTACT', 'phone': '0833 773899'}], 'facility': 'Ravenna Hospital - AUSL Romagna', 'geoPoint': {'lat': 44.41344, 'lon': 12.20121}}, {'zip': '42100', 'city': 'Reggio Emilia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alessia Tieghi, MD', 'role': 'CONTACT', 'phone': '0522 296673'}], 'facility': 'A.O. Reggio Emilia', 'geoPoint': {'lat': 44.69825, 'lon': 10.63125}}, {'zip': '47923', 'city': 'Rimini', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Patrizia Tosi, MD', 'role': 'CONTACT', 'phone': '0541 705111'}], 'facility': 'Rimini Hospital-AUSL Romagna', 'geoPoint': {'lat': 44.05755, 'lon': 12.56528}}], 'centralContacts': [{'name': 'Benedetta Cambò, MD', 'role': 'CONTACT', 'email': 'bcambo@ao.pr.it', 'phone': '0521 704446'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliero-Universitaria di Parma', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Benedetta Cambò', 'investigatorAffiliation': 'Azienda Ospedaliero-Universitaria di Parma'}}}}