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
Sites (24)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Azienda Ospedaliero Universitaria delle Marche - S.O.D. Clinica Ematologica Coordinator of this site? Confirm its status | Ancona | Italy | Unknown status |
| A.O.R.N. S. Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico Coordinator of this site? Confirm its status | Avellino | Italy | Unknown 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 | Aviano | Italy | Unknown status |
| I.R.C.C.S. Istituto Tumori Giovanni Paolo II - U.O.C. Ematologia Coordinator of this site? Confirm its status | Bari | Italy | Unknown status |
| A.S.S.T. Spedali Civili - S.C. Ematologia Coordinator of this site? Confirm its status | Brescia | Italy | Unknown status |
| A.R.N.A.S. "Brotzu" P.O. Businco - S.C. Ematologia e TMO Coordinator of this site? Confirm its status | Cagliari | Italy | Unknown status |
| A.O.U. Careggi - S.O.D. Ematologia Coordinator of this site? Confirm its status | Florence | Italy | Unknown status |
| A.S.S.T. Grande Ospedale Metropolitano Niguarda - S.C. Ematologia Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| I.R.C.C.S. Fondazione Cà Granda Ospedale Maggiore Policlinico - S.C. Ematologia Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| I.R.C.C.S. Fondazione San Gerardo dei Tintori - S.C. Ematologia Coordinator of this site? Confirm its status | Monza | Italy | Unknown status |
| I.R.C.C.S. Istituto Oncologico Veneto - U.O.C. Oncologia 1 Coordinator of this site? Confirm its status | Padova | Italy | Unknown status |
| A.O.U. Policlinico "Paolo Giaccone" - U.O.C. Ematologia Coordinator of this site? Confirm its status | Palermo | Italy | Unknown status |
| Azienda Ospedaliero Universitaria di Parma - S.C. Ematologia e C.T.M.O. Coordinator of this site? Confirm its status | Parma | Italy | Unknown 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 | Piacenza | Italy | Unknown status |
| Azienda USL Toscana Centro - SOS Oncoematologia Coordinator of this site? Confirm its status | Prato | Italy | Unknown status |
| A.U.S.L. di Ravenna Osp. S. Maria delle Croci - U.O.C. Ematologia Coordinator of this site? Confirm its status | Ravenna | Italy | Unknown 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 Emilia | Italy | Unknown status |
| Fondazione Policlinico Campus Bio-Medico - U.O.C. Ematologia e trapianto di cellule staminali Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| A.O.U. Senese - U.O.C. Ematologia Coordinator of this site? Confirm its status | Siena | Italy | Unknown status |
| A.S.L. Teramo Osp. "Giuseppe Mazzini" - U.O.S. Ematologia Coordinator of this site? Confirm its status | Teramo | Italy | Unknown status |
| A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia Coordinator of this site? Confirm its status | Torino | Italy | Unknown status |
| A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia U Coordinator of this site? Confirm its status | Torino | Italy | Unknown status |
| A.S.U. Friuli Centrale - Clinica Ematologica Coordinator of this site? Confirm its status | Udine | Italy | Unknown status |
| A.O.U.I. di Verona - U.O.C. Ematologia Coordinator of this site? Confirm its status | Verona | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.