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

Fondazione Italiana Linfomi - ETS

Status: Begins enrollment this month

Conditions: Diffuse Large B Cell Lymphoma; Follicular Lymphoma Grade 3B

Treatments: Other: Conventional supportive care; Other: Geriatric-guided supportive care

Study type: Interventional

Funder types: Other

Identifiers

NCT07476105

FIL_Elderly Project 2.0

Details and patient eligibility

About

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.

Enrollment: 170 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

170 participants in 2 patient groups

Geriatric-guided supportive care

Experimental group

Description:

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.

Treatment:

Other: Geriatric-guided supportive care

Conventional supportive care

Active Comparator group

Description:

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.

Treatment:

Other: Conventional supportive care