Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-28 @ 2:05 PM
Study NCT ID:
NCT05450367
Status:
COMPLETED
Last Update Posted:
2025-09-12
First Post:
2022-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictive Markers of Response and Toxicity in Patients With a Haematological Malignancy Treated With Immunotherapy.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 249}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-05', 'studyFirstSubmitDate': '2022-06-27', 'studyFirstSubmitQcDate': '2022-07-05', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of complete response', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Treatment response : Explore the proportion of complete response'}, {'measure': 'Proportion of partial response', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Treatment response : Explore the proportion of partial response'}, {'measure': 'Proportion of stable disease', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Treatment response : Explore the proportion of stable disease'}, {'measure': 'Proportion of progress disease', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Treatment response : Explore the proportion of progress disease'}], 'secondaryOutcomes': [{'measure': 'Incidence of grade III adverse events', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Toxicity : Explore the cumulative incidence of grade III and IV adverse events'}, {'measure': 'Incidence of grade IV adverse events', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Toxicity : Explore the cumulative incidence of grade III and IV adverse events'}, {'measure': 'Interruption rates of immunotherapy', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Toxicity : Explore the interruption and discontinuation rates of immunotherapy'}, {'measure': 'Discontinuation rates of immunotherapy', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Toxicity : Explore the interruption and discontinuation rates of immunotherapy'}, {'measure': 'Time interval between the date of initiation treatment and the date of first progression', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Progression free survival'}, {'measure': 'Time interval between the date of initiation treatment and the date of death from any cause', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Overall survival'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Haematologic malignancies', 'Immunotherapy', 'Response predictor', 'Immune-related adverse event'], 'conditions': ['Blood Cancer']}, 'referencesModule': {'references': [{'pmid': '37627056', 'type': 'BACKGROUND', 'citation': 'Detroit M, Collier M, Beeker N, Willems L, Decroocq J, Deau-Fischer B, Vignon M, Birsen R, Moufle F, Leclaire C, Balladur E, Deschamps P, Chauchet A, Batista R, Limat S, Treluyer JM, Ricard L, Stocker N, Hermine O, Choquet S, Morel V, Metz C, Bouscary D, Kroemer M, Zerbit J. Predictive Factors of Response to Immunotherapy in Lymphomas: A Multicentre Clinical Data Warehouse Study (PRONOSTIM). Cancers (Basel). 2023 Aug 9;15(16):4028. doi: 10.3390/cancers15164028.'}]}, 'descriptionModule': {'briefSummary': "Immunotherapies have substantially improved the prognosis of patients with haematological malignancies. While clinical trial data suggest durable complete response rates, markers associated with non-response to treatment are still poorly described. The identification of predictive markers using demographic, physiologic, biologic, immunologic data as well as patients' treatment history, might enable the optimization of therapeutic sequences and the reduction of treatment toxicity.\n\nThis study aim to assess markers of toxicity and response following an immunotherapy in patients with a haematological malignancy using real life data.\n\nIt will allow the development of clinical and therapeutic benchmarks to guide medical decisions in relation to the therapeutic strategies to be implemented for patients benefiting from real-life conditions, in addition to the results obtained in randomized studies."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients diagnosed with a haematological malignancy and treated with immunotherapy', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria :\n\n* adult \\>or= 18 years old,\n* Suffering from one of the following pathologies: Hodgkin's lymphoma, Diffuse large B-cell lymphoma, Mantle B-cell lymphoma, Acute myeloid leukemia, Acute lymphoid leukemia, Peripheral T-cell lymphoma,\n* Patients treated wuth any of the following immunotherapy : nivolumab, pembrolizumab, brentuximab vedotin, axicabtagene ciloleucel, tisagenlecleucel, brexucabtagene autoleucel, gentuzumab ozogamicine, polatuzumab vedotin and blinatumomab,\n\nExclusion Criteria :\n\n\\- Patients opposed to the collection of their personnal data"}, 'identificationModule': {'nctId': 'NCT05450367', 'acronym': 'PRONOSTIM', 'briefTitle': 'Predictive Markers of Response and Toxicity in Patients With a Haematological Malignancy Treated With Immunotherapy.', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Predictive Markers of Response and Toxicity in Patients With a Haematological Malignancy Treated With Immunotherapy.', 'orgStudyIdInfo': {'id': 'APHP220632'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with a haematological malignancy treated with immunotherapy', 'interventionNames': ['Other: Data collection']}], 'interventions': [{'name': 'Data collection', 'type': 'OTHER', 'description': 'Data collection', 'armGroupLabels': ['patients with a haematological malignancy treated with immunotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Assistance Publique - Hôpitaux de Paris (AP-HP) - Cochin Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Jeremie Zerbit, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'URC-CIC Paris Descartes Necker Cochin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}