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

Starting soon · Not applicable

Conditions studied: Diffuse Large B Cell Lymphoma, Follicular Lymphoma Grade 3B

In brief

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.

Key facts

Study ID: NCT07476105
Run by: Fondazione Italiana Linfomi - ETS
People needed: 170
Starts: 2026-05-01
Expected to finish: 2029-05-01
Last updated by the study team: 2026-04-15

Who can join

Age: 70 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Diagnosis of DLBCL or Follicular Lymphoma (FL) grade IIIB.
Age ≥ 70 years.
UNFIT or FRAIL status according to sGA evaluated by the onco-hematologist at baseline.
Patients eligible to a curative intent standard first line chemoimmunotherapy.
Ability to understand and willingness to comply with study procedures.
Signature of a written informed consent.

You may not qualify if…

Patients not meeting at least one of the inclusion criteria listed above.
Refuse to sign a written informed consent.

Where it is running

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

Full record on ClinicalTrials.gov

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