Diffuse Large B Cell LymphomaNCT07476105
Geriatric-guided Care Versus Conventional Care in Elderly Unfit/Frail Patients With Diffuse Large B-cell Lymphoma in First Line Treatment
A study testing Geriatric-guided supportive care and Conventional supportive care in people with Diffuse Large B Cell Lymphoma and Follicular Lymphoma Grade 3B, run by Fondazione Italiana Linfomi - ETS at 24 sites in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Diffuse Large B Cell Lymphoma, Follicular Lymphoma Grade 3B
- What is being tested?
- Geriatric-guided supportive care and Conventional supportive care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 24 sitesItaly
- Study dates
- May 2026to May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- Patients not meeting at least one of the inclusion criteria listed above.
- Refuse to sign a written informed consent.
Trial locations and contacts
24 sites in 1 country. Contact the study team or a site near you to ask about taking part.
24 sites in 1 country
Italy24 sites
Azienda Ospedaliero Universitaria delle Marche - S.O.D. Clinica Ematologica
Ancona
Guido Gini, MD, guido.gini@ospedaliriuniti.marche.it
Guido Gini, MD
A.O.R.N. S. Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico
Avellino
Sonya De Lorenzo, MD, sonya.delorenzo@tin.it
Sonya De Lorenzo, MD
I.R.C.C.S. Centro di Riferimento Oncologico - S.O.C. Oncologia medica e dei tumori immuno-correlati
Aviano
Michele Spina, MD, mspina@cro.it
Michele Spina, MD
I.R.C.C.S. Istituto Tumori Giovanni Paolo II - U.O.C. Ematologia
Bari
Carla Minoia, MD, carla.minoia1@gmail.com
Carla Minoia, MD
A.S.S.T. Spedali Civili - S.C. Ematologia
Brescia
Alessandra Tucci, MD, alessandra.tucci@asst-spedalicivili.it
Alessandra Tucci, MD
A.R.N.A.S. "Brotzu" P.O. Businco - S.C. Ematologia e TMO
Cagliari
Sara Veronica Usai, MD, sara.v.usai@aob.it
Sara Veronica Usai, MD
A.O.U. Careggi - S.O.D. Ematologia
Florence
Benedetta Sordi, MD, benedetta.sordi@unifi.it
Benedetta Sordi, MD
A.S.S.T. Grande Ospedale Metropolitano Niguarda - S.C. Ematologia
Milan
Vittorio Ruggero Zilioli, MD, vittorioruggero.zilioli@ospedaleniguarda.it
Vittorio Ruggero Zilioli, MD
I.R.C.C.S. Fondazione Cà Granda Ospedale Maggiore Policlinico - S.C. Ematologia
Milan
Francesca Gaia Rossi Dardanoni, MD, francescagaia.rossi@policlinico.mi.it
Francesca Gaia Rossi Dardanoni, MD
I.R.C.C.S. Fondazione San Gerardo dei Tintori - S.C. Ematologia
Monza
Federica Cocito, MD, cocitofederica@gmail.com
Federica Cocito, MD
I.R.C.C.S. Istituto Oncologico Veneto - U.O.C. Oncologia 1
Padova
Dario Marino, MD, dario.marino@iov.veneto.it
Dario Marino, MD
A.O.U. Policlinico "Paolo Giaccone" - U.O.C. Ematologia
Palermo
Salvatrice Mancuso, MD, salvatrice.mancuso@unipa.it
Salvatrice Mancuso, MD
Azienda Ospedaliero Universitaria di Parma - S.C. Ematologia e C.T.M.O.
Parma
Luca Pagliaro, MD, luca.pagliaro@unipr.it
Luca Pagliaro, MD
A.U.S.L. di Piacenza Osp. Guglielmo da Saliceto - U.O.C. Ematologia e Centro Trapianti
Piacenza
Annalisa Arcari, MD, a.arcari@ausl.pc.it
Annalisa Arcari, MD
Azienda USL Toscana Centro - SOS Oncoematologia
Prato
Lara Mannelli, MD, lara.mannelli@uslcentro.toscana.it
Lara Mannelli, MD
A.U.S.L. di Ravenna Osp. S. Maria delle Croci - U.O.C. Ematologia
Ravenna
Monica Tani, MD, monica.tani@auslromagna.it
Monica Tani, MD
A.U.S.L. I.R.C.C.S. Arcispedale S. Maria Nuova - S.C. Ematologia
Reggio Emilia
Stefano Luminari, MD, stefano.luminari@ausl.re.it
Stefano Luminari, MD
Fondazione Policlinico Campus Bio-Medico - U.O.C. Ematologia e trapianto di cellule staminali
Roma
Ombretta Annibali, MD, o.annibali@policlinicocampus.it
Ombretta Annibali, MD
A.O.U. Senese - U.O.C. Ematologia
Siena
Alberto Fabbri, MD, fabbri7@unisi.it
Alberto Fabbri, MD
A.S.L. Teramo Osp. "Giuseppe Mazzini" - U.O.S. Ematologia
Teramo
Angelo Fama, MD, angelo.fama@aslteramo.it
Angelo Fama, MD
A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia U
Torino
Michele Clerico, MD, mclerico@cittadellasalute.to.it
Michele Clerico, MD
A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia
Torino
Barbara Botto, MD, bbotto@cittadellasalute.to.it
Barbara Botto, MD
A.S.U. Friuli Centrale - Clinica Ematologica
Udine
Jacopo Olivieri, MD, jacopo.olivieri@asufc.sanita.fvg.it
Jacopo Olivieri, MD
A.O.U.I. di Verona - U.O.C. Ematologia
Verona
Francesca Maria Quaglia, MD, francescamaria.quaglia@aovr.veneto.it
Francesca Maria Quaglia, MD
About this study
Official title: 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.
- Being tested
- Geriatric-guided supportive care, Conventional supportive care
- Keywords
- Diffuse Large B Cell Lymphoma, Follicular Lymphoma Grade 3B, unfit, frail, cluster, R-CHOP, geriatric, sGA, elderly, caregiver
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geriatric-guided supportive careOther
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.
Conventional supportive careOther
Supportive care will be delivered according to local clinical practice
| Study group | Role | What they receive |
|---|---|---|
| Geriatric-guided supportive care | Experimental | 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. Receives: Other: Geriatric-guided supportive care |
| Conventional supportive care | Active comparator | 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. Receives: Other: Conventional supportive care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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").
Measured: From the beginning of the study up to 6 months after last enrolled patient (up 30 months from study beginning)
Secondary outcomes (18)
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)
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").
Measured: 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)
Change in simplified Geriatric Assessment (sGA) classes assessed at baseline, 3, 6, and 12 months. sGA scale: fit, unfit, frail
Measured: From the beginning up to the end of study (up to 36 months)
To compare eventual dose reductions of therapeutic treatments between groups.
Chemoimmunotherapy dose reductions rate stratified according to therapeutic choices and delivered dose intensity
Measured: 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)
Overall survival evaluation stratified according to sGA
Measured: From the beginning up to the end of study (up to 36 months)
To compare the treatment completion rate between groups
Rate of Treatment completion, defined as the proportion of patients who complete the planned chemoimmunotherapy without premature discontinuation.
Measured: 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.
Early mortality proportion, defined as death from any cause within 90 days of enrollment.
Measured: 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.
Overall Response Rate (ORR) and Complete Response Rate (CRR), assessed according to Lugano classification at end of treatment,
Measured: 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.
Progression-Free Survival (PFS) and Overall Survival (OS), defined according to standard criteria, with time measured from date of enrollment.
Measured: From the beginning up to the end of study (up to 36 months)
To compare hospitalization rates between groups.
Healthcare resource utilization: Incidence of hospital admissions
Measured: 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.
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")
Measured: 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.
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).
Measured: From the beginning up to the end of study (up to 36 months)
To compare median hospital stay between groups.
Healthcare resource utilization: Mean duration of hospital stay (in days)
Measured: From the beginning up to the end of study (up to 36 months)
To compare emergency department access rate between groups.
Healthcare resource utilization: Incidence of emergency department accesses
Measured: From the beginning up to the end of study (up to 36 months)
To compare hospice admission rate between groups.
Healthcare resource utilization: Incidence of patients admitted to hospice during follow-up
Measured: From the beginning up to the end of study (up to 36 months)
To compare eventual dose delays of therapeutic treatments between groups.
Chemoimmunotherapy dose delays rate stratified according to therapeutic choices and delivered dose intensity
Measured: 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).
Overall survival evaluation stratified according to BMI value
Measured: 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).
Overall survival evaluation stratified according to serum albumine value
Measured: 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).
Overall survival evaluation stratified according to caregiver availability
Measured: From the beginning up to the end of study (up to 36 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study startMay 2026 (estimated)
- Primary completionNov 2028 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- non-randomized cluster controlled
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Italiana Linfomi - ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benedetta Sordi, MD, Principal investigator, A.O.U. Careggi di Firenze - S.O.D. Ematologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07476105
- Sponsor's protocol ID
- FIL_Elderly Project 2.0
- Status last verified
- Apr 2026
- First submitted
- 26 Feb 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07476105
- Acronym / sponsor ID
- FIL_Elderly Project 2.0
- Keywords
- Diffuse Large B Cell Lymphoma, Follicular Lymphoma Grade 3B, unfit, frail, cluster, R-CHOP, geriatric, sGA
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Fondazione Italiana Linfomi - ETSUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- non-randomized cluster controlled
| Arm | Type | Receives |
|---|---|---|
| Geriatric-guided supportive care | Experimental | Other: Geriatric-guided supportive carePatients 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. |
| Conventional supportive care | Active comparator | Other: Conventional supportive carePatients will be treated for lymphoma according to standard clinical practice. Patients will receive supportive care according to standard clinical practice without systematic geriatric input. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients not meeting at least one of the inclusion criteria listed above.
- Refuse to sign a written informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Geriatric-guided supportive careStructured 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 |
| Conventional supportive careSupportive care will be delivered according to local clinical practice | Other | Conventional supportive care |
Primary outcome
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").
18 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
To compare hospitalization rates between groups.
Time frame: 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)
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)
To compare median hospital stay between groups.
Time frame: 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)
To compare hospice admission rate between groups.
Time frame: 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)
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)
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Benedetta Sordi, MD principal investigator
A.O.U. Careggi di Firenze - S.O.D. Ematologia
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Geriatric-guided supportive care and Conventional supportive care in people with Diffuse Large B Cell Lymphoma and Follicular Lymphoma Grade 3B, run by Fondazione Italiana Linfomi - ETS at 24 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Uffici Studi FIL (+390131033153, startup@filinf.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.