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ClinicalTrials.gov ID

NCT07476105

Lead Sponsor

Fondazione Italiana Linfomi - ETSOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

170Estimated

Last Update Posted

Apr 15, 2026Actual

Start Date

May 2026Estimated

Primary Completion Date

Nov 2028Estimated

Completion Date

May 2029Estimated

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

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.

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

• Geriatric-guided supportive care
• Conventional supportive care

Ages Eligible for Study

Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Primary Purpose

Supportive Care

Allocation

Non-Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Fondazione Italiana Linfomi - ETSOTHER

alessandra.tucci@asst-spedalicivili.it

benedetta.sordi@unifi.it

lara.mannelli@uslcentro.toscana.it

fabbri7@unisi.it

jacopo.olivieri@asufc.sanita.fvg.it

francescamaria.quaglia@aovr.veneto.it