Geriatric-guided Care Versus Conventional Care in Elderly Unfit/Frail Patients With Diffuse Large B-cell Lymphoma in First Line Treatment

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. A 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. This 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.

NCT Number	NCT07476105
Lead Sponsor	Fondazione Italiana Linfomi - ETS
Conditions	Diffuse Large B Cell Lymphoma, Follicular Lymphoma Grade 3B
Enrollment	170 participants
Start Date	2026-05
Primary Completion	2028-11 (estimated)
Study Completion	2029-05 (estimated)
Updated on ClinicalTrials.gov	2026-04-15