Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-04-05 @ 11:52 PM
Study NCT ID:
NCT07476105
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-17
First Post:
2026-02-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Geriatric-guided Care Versus Conventional Care in Elderly Unfit/Frail Patients With Diffuse Large B-cell Lymphoma in First Line Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'non-randomized cluster controlled'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 170}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2029-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-11', 'studyFirstSubmitDate': '2026-02-26', 'studyFirstSubmitQcDate': '2026-03-11', 'lastUpdatePostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate whether a geriatric-guided approach improves health-related quality of life (HRQL) in elderly patients with DLBCL eligible for first-line chemoimmunotherapy, compared to a conventional approach.', 'timeFrame': 'From the beginning of the study up to 6 months after last enrolled patient (up 30 months from study beginning)', 'description': 'Change in the Global Health Status/QoL score of the EORTC Quality of Life Core 30 From baseline to end of treatment (6 months after enrollment). EORTC QLQ-C30 questionnaire: ranking from 1 ("not at all") to 4 ("very much").'}], 'secondaryOutcomes': [{'measure': 'To assess changes in the functioning scales and symptom scales of the EORTC QLQ-C30 performed at baseline, 3, 6, and 12 months in both study groups (geriatric-guided vs conventional approach)', 'timeFrame': 'From the beginning up to the end of study (up to 36 months)', 'description': 'Change from baseline in the functioning scales (physical, role, emotional, cognitive, social) and symptom scales (e.g., fatigue, pain, nausea/vomiting) of the EORTC QLQ-C30 at 3, 6, and 12 months. EORTC QLQ-C30 questionnaire: ranking from 1 ("not at all") to 4 ("very much").'}, {'measure': 'To assess changes in simplified Geriatric Assessment (sGA) performed at baseline, 3, 6, and 12 months in both study groups (geriatric-guided vs conventional approach)', 'timeFrame': 'From the beginning up to the end of study (up to 36 months)', 'description': 'Change in simplified Geriatric Assessment (sGA) classes assessed at baseline, 3, 6, and 12 months. sGA scale: fit, unfit, frail'}, {'measure': 'To compare eventual dose reductions of therapeutic treatments between groups.', 'timeFrame': 'From the beginning of the study up to 6 months after last enrolled patient (up 30 months from study beginning)', 'description': 'Chemoimmunotherapy dose reductions rate stratified according to therapeutic choices and delivered dose intensity'}, {'measure': 'To evaluate the prognostic impact of sGA on overall survival (OS)', 'timeFrame': 'From the beginning up to the end of study (up to 36 months)', 'description': 'Overall survival evaluation stratified according to sGA'}, {'measure': 'To compare the treatment completion rate between groups', 'timeFrame': 'From the beginning of the study up to 6 months after last enrolled patient (up 30 months from study beginning)', 'description': 'Rate of Treatment completion, defined as the proportion of patients who complete the planned chemoimmunotherapy without premature discontinuation.'}, {'measure': 'To assess early mortality rate (within 90 days) in the two groups.', 'timeFrame': 'From the beginning of the study up to 90 days after last enrolled patient (up 27 months from study beginning)', 'description': 'Early mortality proportion, defined as death from any cause within 90 days of enrollment.'}, {'measure': 'To compare overall response rate (ORR) and complete response rate (CRR) between groups.', 'timeFrame': 'From the beginning of the study up to 6 months after last enrolled patient (up 30 months from study beginning)', 'description': 'Overall Response Rate (ORR) and Complete Response Rate (CRR), assessed according to Lugano classification at end of treatment,'}, {'measure': 'To evaluate progression-free survival (PFS) and overall survival (OS) in the two groups.', 'timeFrame': 'From the beginning up to the end of study (up to 36 months)', 'description': 'Progression-Free Survival (PFS) and Overall Survival (OS), defined according to standard criteria, with time measured from date of enrollment.'}, {'measure': 'To compare hospitalization rates between groups.', 'timeFrame': 'From the beginning up to the end of study (up to 36 months)', 'description': 'Healthcare resource utilization: Incidence of hospital admissions'}, {'measure': 'To assess caregiver quality of life and caregiver-related outcomes measured by the CareGiver Oncology Quality of life questionnaire (CarGOQoL) at baseline, 3, 6, and 12 months in both groups.', 'timeFrame': 'From the beginning up to the end of study (up to 36 months)', 'description': 'Caregiver-reported outcomes, including caregiver Quality of Life and burden, assessed at baseline, 3, 6, and 12 months using The CareGiver Oncology Quality of life questionnaire (CarGOQoL). CarGOQoL: rank from 0 ("never/not at all") to 5 ("always/enormously")'}, {'measure': 'To evaluate modifications in the Fried frailty index assessed only in the geriatric-guided arm (performed at baseline, 3, 6, and 12 months) and if there is a concordance between sGA and Fried score.', 'timeFrame': 'From the beginning up to the end of study (up to 36 months)', 'description': 'Change in the Fried frailty index assessed in the geriatric-guided arm, performed at baseline, 3, 6, and 12 months. Assessment if a dynamic change of fitness class is present and if it differs significantly from sGA (performed in both arms). Fried score and sGA: fit (robust), unfit (pre-frail), frail (frail).'}, {'measure': 'To compare median hospital stay between groups.', 'timeFrame': 'From the beginning up to the end of study (up to 36 months)', 'description': 'Healthcare resource utilization: Mean duration of hospital stay (in days)'}, {'measure': 'To compare emergency department access rate between groups.', 'timeFrame': 'From the beginning up to the end of study (up to 36 months)', 'description': 'Healthcare resource utilization: Incidence of emergency department accesses'}, {'measure': 'To compare hospice admission rate between groups.', 'timeFrame': 'From the beginning up to the end of study (up to 36 months)', 'description': 'Healthcare resource utilization: Incidence of patients admitted to hospice during follow-up'}, {'measure': 'To compare eventual dose delays of therapeutic treatments between groups.', 'timeFrame': 'From the beginning of the study up to 6 months after last enrolled patient (up 30 months from study beginning)', 'description': 'Chemoimmunotherapy dose delays rate stratified according to therapeutic choices and delivered dose intensity'}, {'measure': 'To evaluate the prognostic impact of Body Mass Index (BMI) on overall survival (OS).', 'timeFrame': 'From the beginning up to the end of study (up to 36 months)', 'description': 'Overall survival evaluation stratified according to BMI value'}, {'measure': 'To evaluate the prognostic impact of serum albumin on overall survival (OS).', 'timeFrame': 'From the beginning up to the end of study (up to 36 months)', 'description': 'Overall survival evaluation stratified according to serum albumine value'}, {'measure': 'To evaluate the prognostic impact of caregiver availability on overall survival (OS).', 'timeFrame': 'From the beginning up to the end of study (up to 36 months)', 'description': 'Overall survival evaluation stratified according to caregiver availability'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diffuse Large B Cell Lymphoma', 'Follicular Lymphoma Grade 3B', 'unfit', 'frail', 'cluster', 'R-CHOP', 'geriatric', 'sGA', 'elderly', 'caregiver'], 'conditions': ['Diffuse Large B Cell Lymphoma', 'Follicular Lymphoma Grade 3B']}, 'descriptionModule': {'briefSummary': 'The aim of this multicenter, non-randomized, cluster controlled trial study is to evaluate the impact of a geriatric-guided approach with a pro-active rehabilitative/nutritional plan for elderly unfit/frail DLBCL patients eligible for receiving chemoimmunotherapy according to the sGA, versus a conventional approach with onco-hematological treatment alone.\n\nA key innovation element of this project is to use a geriatric-guided approach to improve the global management of all frailty aspects (nutritional, functional, cognitive, social), chasing a better tolerance and completion rate of treatment, tailoring safety and efficacy of therapies in unfit/frail DLBCL patients.\n\nThis study may lead to a personalized approach for elderly DLBCL patients, taking into account a multidisciplinary and fully-integrated program, with the primary aim of improving the quality of life of patients and their families.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of DLBCL or Follicular Lymphoma (FL) grade IIIB.\n2. Age ≥ 70 years.\n3. UNFIT or FRAIL status according to sGA evaluated by the onco-hematologist at baseline.\n4. Patients eligible to a curative intent standard first line chemoimmunotherapy.\n5. Ability to understand and willingness to comply with study procedures.\n6. Signature of a written informed consent.\n\nExclusion Criteria:\n\n1. Patients not meeting at least one of the inclusion criteria listed above.\n2. Refuse to sign a written informed consent.'}, 'identificationModule': {'nctId': 'NCT07476105', 'briefTitle': 'Geriatric-guided Care Versus Conventional Care in Elderly Unfit/Frail Patients With Diffuse Large B-cell Lymphoma in First Line Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Italiana Linfomi - ETS'}, 'officialTitle': 'Geriatric-guided Care Versus Conventional Care in Elderly Unfit/Frail Patients With Diffuse Large B-cell Lymphoma in First Line Treatment. The Elderly Project 2.0: Non-randomized Cluster Controlled Trial', 'orgStudyIdInfo': {'id': 'FIL_Elderly Project 2.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Geriatric-guided supportive care', 'description': 'Patients will be treated for lymphoma according to standard clinical practice. Patients will receive a geriatric-guided supportive care with structured geriatric consultation, along with a nutritional and physiotherapy evaluation, before treatment initiation and with subsequent follow-up assessments aimed at optimizing comorbidity management, nutritional and functional status, along with treatment tolerance.', 'interventionNames': ['Other: Geriatric-guided supportive care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional supportive care', 'description': 'Patients will be treated for lymphoma according to standard clinical practice. Patients will receive supportive care according to standard clinical practice without systematic geriatric input.', 'interventionNames': ['Other: Conventional supportive care']}], 'interventions': [{'name': 'Geriatric-guided supportive care', 'type': 'OTHER', 'description': 'Structured geriatric consultation, along with a nutritional and physiotherapy evaluation, before treatment initiation and with subsequent follow-up assessments aimed at optimizing comorbidity management, nutritional and functional status, along with treatment tolerance.', 'armGroupLabels': ['Geriatric-guided supportive care']}, {'name': 'Conventional supportive care', 'type': 'OTHER', 'description': 'Supportive care will be delivered according to local clinical practice', 'armGroupLabels': ['Conventional supportive care']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Italiana Linfomi - ETS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}