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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
170

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fondazione Italiana Linfomi - ETS

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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