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

April 14, 2026 updated by: Fondazione Italiana Linfomi - ETS

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Ancona, Italy
        • Azienda Ospedaliero Universitaria delle Marche - S.O.D. Clinica Ematologica
        • Principal Investigator:
          • Guido Gini, MD
        • Contact:
      • Avellino, Italy
        • A.O.R.N. S. Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico
        • Contact:
        • Principal Investigator:
          • Sonya De Lorenzo, MD
      • Aviano, Italy
        • I.R.C.C.S. Centro di Riferimento Oncologico - S.O.C. Oncologia medica e dei tumori immuno-correlati
        • Contact:
        • Principal Investigator:
          • Michele Spina, MD
      • Bari, Italy
        • I.R.C.C.S. Istituto Tumori Giovanni Paolo II - U.O.C. Ematologia
        • Principal Investigator:
          • Carla Minoia, MD
        • Contact:
      • Brescia, Italy
      • Cagliari, Italy
        • A.R.N.A.S. "Brotzu" P.O. Businco - S.C. Ematologia e TMO
        • Contact:
        • Principal Investigator:
          • Sara Veronica Usai, MD
      • Florence, Italy
        • A.O.U. Careggi - S.O.D. Ematologia
        • Contact:
        • Principal Investigator:
          • Benedetta Sordi, MD
      • Milan, Italy
      • Milan, Italy
        • I.R.C.C.S. Fondazione Cà Granda Ospedale Maggiore Policlinico - S.C. Ematologia
        • Contact:
        • Principal Investigator:
          • Francesca Gaia Rossi Dardanoni, MD
      • Monza, Italy
        • I.R.C.C.S. Fondazione San Gerardo dei Tintori - S.C. Ematologia
        • Contact:
        • Principal Investigator:
          • Federica Cocito, MD
      • Padova, Italy
        • I.R.C.C.S. Istituto Oncologico Veneto - U.O.C. Oncologia 1
        • Contact:
        • Principal Investigator:
          • Dario Marino, MD
      • Palermo, Italy
        • A.O.U. Policlinico "Paolo Giaccone" - U.O.C. Ematologia
        • Contact:
        • Principal Investigator:
          • Salvatrice Mancuso, MD
      • Parma, Italy
        • Azienda Ospedaliero Universitaria di Parma - S.C. Ematologia e C.T.M.O.
        • Contact:
        • Principal Investigator:
          • Luca Pagliaro, MD
      • Piacenza, Italy
        • A.U.S.L. di Piacenza Osp. Guglielmo da Saliceto - U.O.C. Ematologia e Centro Trapianti
        • Contact:
        • Principal Investigator:
          • Annalisa Arcari, MD
      • Prato, Italy
      • Ravenna, Italy
        • A.U.S.L. di Ravenna Osp. S. Maria delle Croci - U.O.C. Ematologia
        • Contact:
        • Principal Investigator:
          • Monica Tani, MD
      • Reggio Emilia, Italy
        • A.U.S.L. I.R.C.C.S. Arcispedale S. Maria Nuova - S.C. Ematologia
        • Contact:
        • Principal Investigator:
          • Stefano Luminari, MD
      • Roma, Italy
        • Fondazione Policlinico Campus Bio-Medico - U.O.C. Ematologia e trapianto di cellule staminali
        • Principal Investigator:
          • Ombretta Annibali, MD
        • Contact:
      • Siena, Italy
        • A.O.U. Senese - U.O.C. Ematologia
        • Contact:
        • Principal Investigator:
          • Alberto Fabbri, MD
      • Teramo, Italy
        • A.S.L. Teramo Osp. "Giuseppe Mazzini" - U.O.S. Ematologia
        • Principal Investigator:
          • Angelo Fama, MD
        • Contact:
      • Torino, Italy
        • A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia
        • Principal Investigator:
          • Barbara Botto, MD
        • Contact:
      • Torino, Italy
        • A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia U
        • Contact:
        • Principal Investigator:
          • Michele Clerico, MD
      • Udine, Italy
      • Verona, Italy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Geriatric-guided supportive care
Patients will be treated for lymphoma according to standard clinical practice. Patients will receive a geriatric-guided supportive care with 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.
Other: 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.
Active Comparator: Conventional supportive care
Patients will be treated for lymphoma according to standard clinical practice. Patients will receive supportive care according to standard clinical practice without systematic geriatric input.
Other: Conventional supportive care
Supportive care will be delivered according to local clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate whether a geriatric-guided approach improves health-related quality of life (HRQL) in elderly patients with DLBCL eligible for first-line chemoimmunotherapy, compared to a conventional approach.
Time Frame: From the beginning of the study up to 6 months after last enrolled patient (up 30 months from study beginning)
Change in the Global Health Status/QoL score of the EORTC Quality of Life Core 30 From baseline to end of treatment (6 months after enrollment). EORTC QLQ-C30 questionnaire: ranking from 1 ("not at all") to 4 ("very much").
From the beginning of the study up to 6 months after last enrolled patient (up 30 months from study beginning)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess changes in the functioning scales and symptom scales of the EORTC QLQ-C30 performed at baseline, 3, 6, and 12 months in both study groups (geriatric-guided vs conventional approach)
Time Frame: From the beginning up to the end of study (up to 36 months)
Change from baseline in the functioning scales (physical, role, emotional, cognitive, social) and symptom scales (e.g., fatigue, pain, nausea/vomiting) of the EORTC QLQ-C30 at 3, 6, and 12 months. EORTC QLQ-C30 questionnaire: ranking from 1 ("not at all") to 4 ("very much").
From the beginning up to the end of study (up to 36 months)
To assess changes in simplified Geriatric Assessment (sGA) performed at baseline, 3, 6, and 12 months in both study groups (geriatric-guided vs conventional approach)
Time Frame: From the beginning up to the end of study (up to 36 months)
Change in simplified Geriatric Assessment (sGA) classes assessed at baseline, 3, 6, and 12 months. sGA scale: fit, unfit, frail
From the beginning up to the end of study (up to 36 months)
To compare eventual dose reductions of therapeutic treatments between groups.
Time Frame: From the beginning of the study up to 6 months after last enrolled patient (up 30 months from study beginning)
Chemoimmunotherapy dose reductions rate stratified according to therapeutic choices and delivered dose intensity
From the beginning of the study up to 6 months after last enrolled patient (up 30 months from study beginning)
To evaluate the prognostic impact of sGA on overall survival (OS)
Time Frame: From the beginning up to the end of study (up to 36 months)
Overall survival evaluation stratified according to sGA
From the beginning up to the end of study (up to 36 months)
To compare the treatment completion rate between groups
Time Frame: From the beginning of the study up to 6 months after last enrolled patient (up 30 months from study beginning)
Rate of Treatment completion, defined as the proportion of patients who complete the planned chemoimmunotherapy without premature discontinuation.
From the beginning of the study up to 6 months after last enrolled patient (up 30 months from study beginning)
To assess early mortality rate (within 90 days) in the two groups.
Time Frame: From the beginning of the study up to 90 days after last enrolled patient (up 27 months from study beginning)
Early mortality proportion, defined as death from any cause within 90 days of enrollment.
From the beginning of the study up to 90 days after last enrolled patient (up 27 months from study beginning)
To compare overall response rate (ORR) and complete response rate (CRR) between groups.
Time Frame: From the beginning of the study up to 6 months after last enrolled patient (up 30 months from study beginning)
Overall Response Rate (ORR) and Complete Response Rate (CRR), assessed according to Lugano classification at end of treatment,
From the beginning of the study up to 6 months after last enrolled patient (up 30 months from study beginning)
To evaluate progression-free survival (PFS) and overall survival (OS) in the two groups.
Time Frame: From the beginning up to the end of study (up to 36 months)
Progression-Free Survival (PFS) and Overall Survival (OS), defined according to standard criteria, with time measured from date of enrollment.
From the beginning up to the end of study (up to 36 months)
To compare hospitalization rates between groups.
Time Frame: From the beginning up to the end of study (up to 36 months)
Healthcare resource utilization: Incidence of hospital admissions
From the beginning up to the end of study (up to 36 months)
To assess caregiver quality of life and caregiver-related outcomes measured by the CareGiver Oncology Quality of life questionnaire (CarGOQoL) at baseline, 3, 6, and 12 months in both groups.
Time Frame: From the beginning up to the end of study (up to 36 months)
Caregiver-reported outcomes, including caregiver Quality of Life and burden, assessed at baseline, 3, 6, and 12 months using The CareGiver Oncology Quality of life questionnaire (CarGOQoL). CarGOQoL: rank from 0 ("never/not at all") to 5 ("always/enormously")
From the beginning up to the end of study (up to 36 months)
To evaluate modifications in the Fried frailty index assessed only in the geriatric-guided arm (performed at baseline, 3, 6, and 12 months) and if there is a concordance between sGA and Fried score.
Time Frame: From the beginning up to the end of study (up to 36 months)
Change in the Fried frailty index assessed in the geriatric-guided arm, performed at baseline, 3, 6, and 12 months. Assessment if a dynamic change of fitness class is present and if it differs significantly from sGA (performed in both arms). Fried score and sGA: fit (robust), unfit (pre-frail), frail (frail).
From the beginning up to the end of study (up to 36 months)
To compare median hospital stay between groups.
Time Frame: From the beginning up to the end of study (up to 36 months)
Healthcare resource utilization: Mean duration of hospital stay (in days)
From the beginning up to the end of study (up to 36 months)
To compare emergency department access rate between groups.
Time Frame: From the beginning up to the end of study (up to 36 months)
Healthcare resource utilization: Incidence of emergency department accesses
From the beginning up to the end of study (up to 36 months)
To compare hospice admission rate between groups.
Time Frame: From the beginning up to the end of study (up to 36 months)
Healthcare resource utilization: Incidence of patients admitted to hospice during follow-up
From the beginning up to the end of study (up to 36 months)
To compare eventual dose delays of therapeutic treatments between groups.
Time Frame: From the beginning of the study up to 6 months after last enrolled patient (up 30 months from study beginning)
Chemoimmunotherapy dose delays rate stratified according to therapeutic choices and delivered dose intensity
From the beginning of the study up to 6 months after last enrolled patient (up 30 months from study beginning)
To evaluate the prognostic impact of Body Mass Index (BMI) on overall survival (OS).
Time Frame: From the beginning up to the end of study (up to 36 months)
Overall survival evaluation stratified according to BMI value
From the beginning up to the end of study (up to 36 months)
To evaluate the prognostic impact of serum albumin on overall survival (OS).
Time Frame: From the beginning up to the end of study (up to 36 months)
Overall survival evaluation stratified according to serum albumine value
From the beginning up to the end of study (up to 36 months)
To evaluate the prognostic impact of caregiver availability on overall survival (OS).
Time Frame: From the beginning up to the end of study (up to 36 months)
Overall survival evaluation stratified according to caregiver availability
From the beginning up to the end of study (up to 36 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Italiana Linfomi - ETS

Investigators

  • Principal Investigator: Benedetta Sordi, MD, A.O.U. Careggi di Firenze - S.O.D. Ematologia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

May 1, 2029

Study Registration Dates

First Submitted

February 26, 2026

First Submitted That Met QC Criteria

March 11, 2026

First Posted (Actual)

March 17, 2026

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIL_Elderly Project 2.0

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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