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

Sponsor
Fondazione Italiana Linfomi - ETS
Study ID
NCT07476105
Status
Not Yet Recruiting

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Conditions

  • Diffuse Large B Cell Lymphoma
  • Follicular Lymphoma Grade 3B

Eligibility Criteria

Sex
ALL
Age
70 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Geriatric-guided supportive care — OTHER
    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 — OTHER
    Supportive care will be delivered according to local clinical practice

Study Details

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.

Key Dates

First listed
Mar 17, 2026
Start date
May 31, 2026
Status verified
Apr 2026
Primary completion
Nov 30, 2028
Completion
May 31, 2029

Study Design

Enrollment
170 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.
  • 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.

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) ]

Central Contacts

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