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NCT07476105Not yet recruiting

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

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

Source: ClinicalTrials.gov · Last updated 15 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
170 (estimated)
First submitted
26 Feb 2026
Start date
May 2026
Primary completion date
Nov 2028
Lead sponsor
Fondazione Italiana Linfomi - ETS
NCT number
NCT07476105

What you commit to

  • Study type: Interventional
  • Planned participants: 170
  • From May 2026 to the primary completion date, Nov 2028
  • 24 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

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

Who the study is looking for

  • 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.

Age in the registry: 70 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (24)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Azienda Ospedaliero Universitaria delle Marche - S.O.D. Clinica Ematologica
Coordinator of this site? Confirm its status
AnconaItalyUnknown status
A.O.R.N. S. Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico
Coordinator of this site? Confirm its status
AvellinoItalyUnknown status
I.R.C.C.S. Centro di Riferimento Oncologico - S.O.C. Oncologia medica e dei tumori immuno-correlati
Coordinator of this site? Confirm its status
AvianoItalyUnknown status
I.R.C.C.S. Istituto Tumori Giovanni Paolo II - U.O.C. Ematologia
Coordinator of this site? Confirm its status
BariItalyUnknown status
A.S.S.T. Spedali Civili - S.C. Ematologia
Coordinator of this site? Confirm its status
BresciaItalyUnknown status
A.R.N.A.S. "Brotzu" P.O. Businco - S.C. Ematologia e TMO
Coordinator of this site? Confirm its status
CagliariItalyUnknown status
A.O.U. Careggi - S.O.D. Ematologia
Coordinator of this site? Confirm its status
FlorenceItalyUnknown status
A.S.S.T. Grande Ospedale Metropolitano Niguarda - S.C. Ematologia
Coordinator of this site? Confirm its status
MilanItalyUnknown status
I.R.C.C.S. Fondazione Cà Granda Ospedale Maggiore Policlinico - S.C. Ematologia
Coordinator of this site? Confirm its status
MilanItalyUnknown status
I.R.C.C.S. Fondazione San Gerardo dei Tintori - S.C. Ematologia
Coordinator of this site? Confirm its status
MonzaItalyUnknown status
I.R.C.C.S. Istituto Oncologico Veneto - U.O.C. Oncologia 1
Coordinator of this site? Confirm its status
PadovaItalyUnknown status
A.O.U. Policlinico "Paolo Giaccone" - U.O.C. Ematologia
Coordinator of this site? Confirm its status
PalermoItalyUnknown status
Azienda Ospedaliero Universitaria di Parma - S.C. Ematologia e C.T.M.O.
Coordinator of this site? Confirm its status
ParmaItalyUnknown status
A.U.S.L. di Piacenza Osp. Guglielmo da Saliceto - U.O.C. Ematologia e Centro Trapianti
Coordinator of this site? Confirm its status
PiacenzaItalyUnknown status
Azienda USL Toscana Centro - SOS Oncoematologia
Coordinator of this site? Confirm its status
PratoItalyUnknown status
A.U.S.L. di Ravenna Osp. S. Maria delle Croci - U.O.C. Ematologia
Coordinator of this site? Confirm its status
RavennaItalyUnknown status
A.U.S.L. I.R.C.C.S. Arcispedale S. Maria Nuova - S.C. Ematologia
Coordinator of this site? Confirm its status
Reggio EmiliaItalyUnknown status
Fondazione Policlinico Campus Bio-Medico - U.O.C. Ematologia e trapianto di cellule staminali
Coordinator of this site? Confirm its status
RomaItalyUnknown status
A.O.U. Senese - U.O.C. Ematologia
Coordinator of this site? Confirm its status
SienaItalyUnknown status
A.S.L. Teramo Osp. "Giuseppe Mazzini" - U.O.S. Ematologia
Coordinator of this site? Confirm its status
TeramoItalyUnknown status
A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia
Coordinator of this site? Confirm its status
TorinoItalyUnknown status
A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia U
Coordinator of this site? Confirm its status
TorinoItalyUnknown status
A.S.U. Friuli Centrale - Clinica Ematologica
Coordinator of this site? Confirm its status
UdineItalyUnknown status
A.O.U.I. di Verona - U.O.C. Ematologia
Coordinator of this site? Confirm its status
VeronaItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.