Ignite Creation Date:
2025-12-24 @ 1:02 PM
Ignite Modification Date:
2025-12-29 @ 3:04 PM
Study NCT ID:
NCT05532761
Status:
UNKNOWN
Last Update Posted:
2022-09-08
First Post:
2022-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multidimensional Assessment of Quality of Life, Social and Professional Life and Care Utilization in Patients With Diffuse Large Cell B-cell Lymphoma Treated With CAR-T Cells
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}], 'ancestors': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-05', 'studyFirstSubmitDate': '2022-09-05', 'studyFirstSubmitQcDate': '2022-09-05', 'lastUpdatePostDateStruct': {'date': '2022-09-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of mean score of FACT-Lym (Functional Assessment of Cancer Therapy - Lymphoma) quality of life', 'timeFrame': 'Baseline (day before chemotherapy of lymphodepletion), Month1, 3, 6, 9, 12 and 18 after injection of CAR-T cells'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diffuse large B-cell lymphoma (DLBCL)', 'CAR-T cells', 'Quality of life', 'Real-life'], 'conditions': ['Diffuse Large B-cell Lymphoma (DLBCL)', 'CAR-T Cells Treatment']}, 'descriptionModule': {'briefSummary': "Immunotherapy became in recent years a major innovation in the care of cancer patients, with unprecedented improvement in complete response and survival, particularly in hematological cancers. Since 2018, patients with relapsed or refractory lymphoma can benefit from immunotherapy based on CAR-T cells (Chimeric Antigenic Receptor - T cells), drugs derived from gene therapy and products from the patient's own T cells. The efficacy of these drugs, their development in more and more indications and in continuous earlier lines of treatment, their unprecedented adverse effects and their very high cost justify the search for predictive factors of efficacy and tolerance in order to optimize their use and benefit the greatest number of eligible patients. A better understanding of quality of life and its determinants in patients who received CAR-T cells could play a major role in predicting efficacy and tolerance. Quality of life data have indeed been deemed insufficient in phase 1-2 trials which have demonstrated the benefit of CAR-T cells in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in 3rd line of treatment or more and led to obtaining their marketing authorization. It is therefore necessary to assess the quality of life of patients treated in routine care with CAR-T cells. The European Qualitop project aims, from self-questionnaires, to explore the quality of life during the 2 years following the initiation of immunotherapy with a multidimensional approach integrating genetic factors, lifestyle habits and psychosocial determinants of patients. In this context, the Qualitop CAR-T study is a prospective non-comparative real-life study aimed at describing the multidimensional quality of life, its psychosocial determinants and drug consumption in patients with relapsed or refractory DLBCL treated with CAR -T cells."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with diffuse large cell B-cell lymphoma followed in the hematology department of Pr GUESQUIERES (Pierre-Bénite, France) whose treatment with CAR-T cells is planned will be offered participation in the QUALITOP CAR-T study.\n\nThe number of patients with DLBCL benefiting annually from treatment with CAR-T cells in hematologic department is around 55.\n\nThe number of subjects to be included, estimated at 30 patients over one year, is therefore compatible with the recruitment', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* over 18 years old\n* eligible for treatment with CAR-Tcells (outside a clinical trial) in an indication of diffuse large B-cell lymphoma for which treatment with CAR-Tcells is scheduled\n* follow-up in the Hematology department of the Hospices Civils de Lyon (Pr. Hervé Ghesquières)\n* having given their non-objection to participate in the study.\n\nExclusion Criteria:\n\n* Adults subject to a measure of legal protection (curatorship, guardianship)\n* Persons deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care and persons admitted to a health or social establishment\n* People with a major psychiatric disorder likely to hinder the conduct of the study, in the opinion of the investigator\n* Not fluent in French-\n* simultaneous participation in another research involving the human person, except if it is a study falling within category 3 of the Jardé Law which does not call into question the follow-up of patients in the present study.'}, 'identificationModule': {'nctId': 'NCT05532761', 'acronym': 'QUALITOP CAR-T', 'briefTitle': 'Multidimensional Assessment of Quality of Life, Social and Professional Life and Care Utilization in Patients With Diffuse Large Cell B-cell Lymphoma Treated With CAR-T Cells', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Multidimensional Assessment of Quality of Life, Social and Professional Life and Care Utilization in Patients With Diffuse Large Cell B-cell Lymphoma Treated With CAR-T Cells', 'orgStudyIdInfo': {'id': '69HCL22_0430'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'diffuse lare B cells lymphoma', 'description': 'Diffuse large B cells lymphoma patients eligibles for CAR-T cells therapy', 'interventionNames': ['Other: self-administered questionnaires']}], 'interventions': [{'name': 'self-administered questionnaires', 'type': 'OTHER', 'description': 'In order to describe the experience of CAR-T cell therapy of DLBCL patients, a pharmaceutical follow-up is carried out the day before the injection (baseline) and at 1, 3, 6, 9, 12 and 18 months. These follow-ups consist of interviews with the patient and the delivery of self-administered questionnaires. The interviews will investigate drug consumption, the use of self-medication and complementary alternative therapies and the adverse effects of interest. The self-questionnaires will focus on exploring multidimensional quality of life, social and professional life, anxiety-depression or uncertainty tolerance through internationally validated questionnaires.\n\nNo supplementary visits will be needed : interviews with the research team will occur at the end of hematologic consultations.', 'armGroupLabels': ['diffuse lare B cells lymphoma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69495', 'city': 'Pierre-Bénite', 'country': 'France', 'contacts': [{'name': 'Magali MAIRE, Ph D', 'role': 'CONTACT', 'email': 'magali.maire@chu-lyon.fr', 'phone': '(0)478864334', 'phoneExt': '+33'}, {'name': 'Catherine RIOUFOL, Pharm D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Service pharmaceutique, Hospices Civils de Lyon - Groupement Hospitalier Sud', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}], 'centralContacts': [{'name': 'Catherine RIOUFOL, Pharm D', 'role': 'CONTACT', 'email': 'catherine.rioufol@chu-lyon.fr', 'phone': '(0)478864368', 'phoneExt': '+33'}, {'name': 'Magali MAIRE, Ph D', 'role': 'CONTACT', 'email': 'magali.maire@chu-lyon.fr', 'phone': '(0)478864334', 'phoneExt': '+33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}