Not yet recruiting NCT07476105

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

No phase Interventional Diffuse Large B Cell Lymphoma Follicular Lymphoma Grade 3B

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Geriatric-guided supportive care, Conventional supportive care.
Who it may be relevant to: Registry conditions: Diffuse Large B Cell Lymphoma, Follicular Lymphoma Grade 3B. Basic parameters: from 70 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Italy
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

Other Geriatric-guided supportive care
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.
Other Conventional supportive care
Supportive care will be delivered according to local clinical practice

Primary outcome measures

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)]

Secondary outcome measures (12)

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) [Time frame: 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) [Time frame: From the beginning up to the end of study (up to 36 months)]
To compare eventual dose reductions of therapeutic treatments between groups. [Time frame: 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) [Time frame: From the beginning up to the end of study (up to 36 months)]
To compare the treatment completion rate between groups [Time frame: From the beginning of the study up to 6 months after last enrolled patient (up 30 months from study beginning)]
To assess early mortality rate (within 90 days) in the two groups. [Time frame: From the beginning of the study up to 90 days after last enrolled patient (up 27 months from study beginning)]
To compare overall response rate (ORR) and complete response rate (CRR) between groups. [Time frame: From the beginning of the study up to 6 months after last enrolled patient (up 30 months from study beginning)]
To evaluate progression-free survival (PFS) and overall survival (OS) in the two groups. [Time frame: From the beginning up to the end of study (up to 36 months)]
To compare hospitalization rates between groups. [Time frame: From the beginning up to the end of study (up to 36 months)]
To assess caregiver quality of life and caregiver-related outcomes measured by the CareGiver Oncology Quality of life questionnaire (CarGOQoL) at baseline, 3, 6, and 12 months in both groups. [Time frame: From the beginning up to the end of study (up to 36 months)]
To evaluate modifications in the Fried frailty index assessed only in the geriatric-guided arm (performed at baseline, 3, 6, and 12 months) and if there is a concordance between sGA and Fried score. [Time frame: From the beginning up to the end of study (up to 36 months)]
To compare median hospital stay between groups. [Time frame: From the beginning up to the end of study (up to 36 months)]

Eligibility criteria

Inclusion criteria

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.

Exclusion criteria

Patients not meeting at least one of the inclusion criteria listed above.
Refuse to sign a written informed consent.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Non-randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Supportive care

Study locations

Italy · 24 centers

Azienda Ospedaliero Universitaria delle Marche - S.O.D. Clinica Ematologica — Ancona
A.O.R.N. S. Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico — Avellino
I.R.C.C.S. Centro di Riferimento Oncologico - S.O.C. Oncologia medica e dei tumori immuno- — Aviano
I.R.C.C.S. Istituto Tumori Giovanni Paolo II - U.O.C. Ematologia — Bari
A.S.S.T. Spedali Civili - S.C. Ematologia — Brescia
A.R.N.A.S. "Brotzu" P.O. Businco - S.C. Ematologia e TMO — Cagliari
A.O.U. Careggi - S.O.D. Ematologia — Florence
A.S.S.T. Grande Ospedale Metropolitano Niguarda - S.C. Ematologia — Milan
… and 16 more centers

Identifiers

NCT: NCT07476105 · FIL_Elderly Project 2.0

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗