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Geriatric-guided Care Versus Conventional Care in Elderly Unfit/Frail Patients With Diffuse Large B-cell Lymphoma in First Line Treatment
Sponsor: Fondazione Italiana Linfomi - ETS
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
70 Years - Any
Study Type
INTERVENTIONAL
Enrollment
170
Start Date
2026-05
Completion Date
2029-05
Last Updated
2026-04-15
Healthy Volunteers
No
Interventions
Geriatric-guided supportive care
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.
Conventional supportive care
Supportive care will be delivered according to local clinical practice
Locations (24)
Azienda Ospedaliero Universitaria delle Marche - S.O.D. Clinica Ematologica
Ancona, Italy
A.O.R.N. S. Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico
Avellino, Italy
I.R.C.C.S. Centro di Riferimento Oncologico - S.O.C. Oncologia medica e dei tumori immuno-correlati
Aviano, Italy
I.R.C.C.S. Istituto Tumori Giovanni Paolo II - U.O.C. Ematologia
Bari, Italy
A.S.S.T. Spedali Civili - S.C. Ematologia
Brescia, Italy
A.R.N.A.S. "Brotzu" P.O. Businco - S.C. Ematologia e TMO
Cagliari, Italy
A.O.U. Careggi - S.O.D. Ematologia
Florence, Italy
A.S.S.T. Grande Ospedale Metropolitano Niguarda - S.C. Ematologia
Milan, Italy
I.R.C.C.S. Fondazione Cà Granda Ospedale Maggiore Policlinico - S.C. Ematologia
Milan, Italy
I.R.C.C.S. Fondazione San Gerardo dei Tintori - S.C. Ematologia
Monza, Italy
I.R.C.C.S. Istituto Oncologico Veneto - U.O.C. Oncologia 1
Padova, Italy
A.O.U. Policlinico "Paolo Giaccone" - U.O.C. Ematologia
Palermo, Italy
Azienda Ospedaliero Universitaria di Parma - S.C. Ematologia e C.T.M.O.
Parma, Italy
A.U.S.L. di Piacenza Osp. Guglielmo da Saliceto - U.O.C. Ematologia e Centro Trapianti
Piacenza, Italy
Azienda USL Toscana Centro - SOS Oncoematologia
Prato, Italy
A.U.S.L. di Ravenna Osp. S. Maria delle Croci - U.O.C. Ematologia
Ravenna, Italy
A.U.S.L. I.R.C.C.S. Arcispedale S. Maria Nuova - S.C. Ematologia
Reggio Emilia, Italy
Fondazione Policlinico Campus Bio-Medico - U.O.C. Ematologia e trapianto di cellule staminali
Roma, Italy
A.O.U. Senese - U.O.C. Ematologia
Siena, Italy
A.S.L. Teramo Osp. "Giuseppe Mazzini" - U.O.S. Ematologia
Teramo, Italy
A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia U
Torino, Italy
A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia
Torino, Italy
A.S.U. Friuli Centrale - Clinica Ematologica
Udine, Italy
A.O.U.I. di Verona - U.O.C. Ematologia
Verona, Italy