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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age70+
SponsorFondazione Italiana Linfomi - ETS

About this 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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

Patients not meeting at least one of the inclusion criteria listed above.

Refuse to sign a written informed consent.

Trial design

Treatments tested in this trial

  • Geriatric-guided supportive care
  • Conventional supportive care

Treatment groups

170 Participants
are divided into 2 treatment groups