Geriatric-guided Care Versus Conventional Care in Elderly Unfit/Frail Patients With Diffuse Large B-cell Lymphoma in First Line Treatment
1 other identifier
interventional
170
1 country
24
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2026
Typical duration for not_applicable
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2026
CompletedFirst Posted
Study publicly available on registry
March 17, 2026
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2029
April 15, 2026
April 1, 2026
2.5 years
February 26, 2026
April 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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").
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)
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)
From the beginning up to the end of study (up to 36 months)
To compare eventual dose reductions of therapeutic treatments between groups.
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)
From the beginning up to the end of study (up to 36 months)
To compare the treatment completion rate between groups
From the beginning of the study up to 6 months after last enrolled patient (up 30 months from study beginning)
- +13 more secondary outcomes
Study Arms (2)
Geriatric-guided supportive care
EXPERIMENTALPatients 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 COMPARATORPatients will be treated for lymphoma according to standard clinical practice. Patients will receive supportive care according to standard clinical practice without systematic geriatric input.
Interventions
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.
Supportive care will be delivered according to local clinical practice
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Refuse to sign a written informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Azienda Ospedaliero Universitaria delle Marche - S.O.D. Clinica Ematologica
Ancona, Italy
A.O.R.N. S. Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico
Avellino, Italy
I.R.C.C.S. Centro di Riferimento Oncologico - S.O.C. Oncologia medica e dei tumori immuno-correlati
Aviano, Italy
I.R.C.C.S. Istituto Tumori Giovanni Paolo II - U.O.C. Ematologia
Bari, Italy
A.S.S.T. Spedali Civili - S.C. Ematologia
Brescia, Italy
A.R.N.A.S. "Brotzu" P.O. Businco - S.C. Ematologia e TMO
Cagliari, Italy
A.O.U. Careggi - S.O.D. Ematologia
Florence, Italy
A.S.S.T. Grande Ospedale Metropolitano Niguarda - S.C. Ematologia
Milan, Italy
I.R.C.C.S. Fondazione Cà Granda Ospedale Maggiore Policlinico - S.C. Ematologia
Milan, Italy
I.R.C.C.S. Fondazione San Gerardo dei Tintori - S.C. Ematologia
Monza, Italy
I.R.C.C.S. Istituto Oncologico Veneto - U.O.C. Oncologia 1
Padova, Italy
A.O.U. Policlinico "Paolo Giaccone" - U.O.C. Ematologia
Palermo, Italy
Azienda Ospedaliero Universitaria di Parma - S.C. Ematologia e C.T.M.O.
Parma, Italy
A.U.S.L. di Piacenza Osp. Guglielmo da Saliceto - U.O.C. Ematologia e Centro Trapianti
Piacenza, Italy
Azienda USL Toscana Centro - SOS Oncoematologia
Prato, Italy
A.U.S.L. di Ravenna Osp. S. Maria delle Croci - U.O.C. Ematologia
Ravenna, Italy
A.U.S.L. I.R.C.C.S. Arcispedale S. Maria Nuova - S.C. Ematologia
Reggio Emilia, Italy
Fondazione Policlinico Campus Bio-Medico - U.O.C. Ematologia e trapianto di cellule staminali
Roma, Italy
A.O.U. Senese - U.O.C. Ematologia
Siena, Italy
A.S.L. Teramo Osp. "Giuseppe Mazzini" - U.O.S. Ematologia
Teramo, Italy
A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia U
Torino, Italy
A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia
Torino, Italy
A.S.U. Friuli Centrale - Clinica Ematologica
Udine, Italy
A.O.U.I. di Verona - U.O.C. Ematologia
Verona, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Benedetta Sordi, MD
A.O.U. Careggi di Firenze - S.O.D. Ematologia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2026
First Posted
March 17, 2026
Study Start
May 1, 2026
Primary Completion (Estimated)
November 1, 2028
Study Completion (Estimated)
May 1, 2029
Last Updated
April 15, 2026
Record last verified: 2026-04