Diffuse Large B Cell Lymphoma, Follicular Lymphoma Grade 3B
Conditions
Keywords
Diffuse Large B Cell Lymphoma, Follicular Lymphoma Grade 3B, unfit, frail, cluster, R-CHOP, geriatric, sGA, elderly, caregiver
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.
Interventions
OTHERGeriatric-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.
OTHERConventional supportive care
Supportive care will be delivered according to local clinical practice
Sponsors
Fondazione Italiana Linfomi - ETS
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
non-randomized cluster controlled
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | From the beginning of the study up to 6 months after last enrolled patient (up 30 months from study beginning) | Change in the Global Health Status/QoL score of the EORTC Quality of Life Core 30 From baseline to end of treatment (6 months after enrollment). EORTC QLQ-C30 questionnaire: ranking from 1 ("not at all") to 4 ("very much"). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | From the beginning up to the end of study (up to 36 months) | Change from baseline in the functioning scales (physical, role, emotional, cognitive, social) and symptom scales (e.g., fatigue, pain, nausea/vomiting) of the EORTC QLQ-C30 at 3, 6, and 12 months. EORTC QLQ-C30 questionnaire: ranking from 1 ("not at all") to 4 ("very much"). |
| 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) | From the beginning up to the end of study (up to 36 months) | Change in simplified Geriatric Assessment (sGA) classes assessed at baseline, 3, 6, and 12 months. sGA scale: fit, unfit, frail |
| To compare eventual dose reductions of therapeutic treatments between groups. | From the beginning of the study up to 6 months after last enrolled patient (up 30 months from study beginning) | Chemoimmunotherapy dose reductions rate stratified according to therapeutic choices and delivered dose intensity |
| To evaluate the prognostic impact of sGA on overall survival (OS) | From the beginning up to the end of study (up to 36 months) | Overall survival evaluation stratified according to sGA |
| To compare the treatment completion rate between groups | From the beginning of the study up to 6 months after last enrolled patient (up 30 months from study beginning) | Rate of Treatment completion, defined as the proportion of patients who complete the planned chemoimmunotherapy without premature discontinuation. |
| To assess early mortality rate (within 90 days) in the two groups. | From the beginning of the study up to 90 days after last enrolled patient (up 27 months from study beginning) | Early mortality proportion, defined as death from any cause within 90 days of enrollment. |
| To compare overall response rate (ORR) and complete response rate (CRR) between groups. | From the beginning of the study up to 6 months after last enrolled patient (up 30 months from study beginning) | Overall Response Rate (ORR) and Complete Response Rate (CRR), assessed according to Lugano classification at end of treatment, |
| To evaluate progression-free survival (PFS) and overall survival (OS) in the two groups. | From the beginning up to the end of study (up to 36 months) | Progression-Free Survival (PFS) and Overall Survival (OS), defined according to standard criteria, with time measured from date of enrollment. |
| To compare hospitalization rates between groups. | From the beginning up to the end of study (up to 36 months) | Healthcare resource utilization: Incidence of hospital admissions |
| 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. | From the beginning up to the end of study (up to 36 months) | Caregiver-reported outcomes, including caregiver Quality of Life and burden, assessed at baseline, 3, 6, and 12 months using The CareGiver Oncology Quality of life questionnaire (CarGOQoL). CarGOQoL: rank from 0 ("never/not at all") to 5 ("always/enormously") |
| 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. | From the beginning up to the end of study (up to 36 months) | Change in the Fried frailty index assessed in the geriatric-guided arm, performed at baseline, 3, 6, and 12 months. Assessment if a dynamic change of fitness class is present and if it differs significantly from sGA (performed in both arms). Fried score and sGA: fit (robust), unfit (pre-frail), frail (frail). |
| To compare median hospital stay between groups. | From the beginning up to the end of study (up to 36 months) | Healthcare resource utilization: Mean duration of hospital stay (in days) |
| To compare emergency department access rate between groups. | From the beginning up to the end of study (up to 36 months) | Healthcare resource utilization: Incidence of emergency department accesses |
| To compare hospice admission rate between groups. | From the beginning up to the end of study (up to 36 months) | Healthcare resource utilization: Incidence of patients admitted to hospice during follow-up |
| To compare eventual dose delays of therapeutic treatments between groups. | From the beginning of the study up to 6 months after last enrolled patient (up 30 months from study beginning) | Chemoimmunotherapy dose delays rate stratified according to therapeutic choices and delivered dose intensity |
| To evaluate the prognostic impact of Body Mass Index (BMI) on overall survival (OS). | From the beginning up to the end of study (up to 36 months) | Overall survival evaluation stratified according to BMI value |
| To evaluate the prognostic impact of serum albumin on overall survival (OS). | From the beginning up to the end of study (up to 36 months) | Overall survival evaluation stratified according to serum albumine value |
| To evaluate the prognostic impact of caregiver availability on overall survival (OS). | From the beginning up to the end of study (up to 36 months) | Overall survival evaluation stratified according to caregiver availability |
Countries
Italy
Contacts
CONTACTUffici Studi FIL
PRINCIPAL_INVESTIGATORBenedetta Sordi, MD
A.O.U. Careggi di Firenze - S.O.D. Ematologia
Outcome results
None listed