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

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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.
• Другое Conventional supportive care
  Supportive care will be delivered according to local clinical practice

Первичные конечные точки

• 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. [Срок оценки: From the beginning of the study up to 6 months after last enrolled patient (up 30 months from study beginning)]

Вторичные конечные точки (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) [Срок оценки: 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) [Срок оценки: From the beginning up to the end of study (up to 36 months)]
• To compare eventual dose reductions of therapeutic treatments between groups. [Срок оценки: 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) [Срок оценки: From the beginning up to the end of study (up to 36 months)]
• To compare the treatment completion rate between groups [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: From the beginning up to the end of study (up to 36 months)]
• To compare hospitalization rates between groups. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: From the beginning up to the end of study (up to 36 months)]
• To compare median hospital stay between groups. [Срок оценки: From the beginning up to the end of study (up to 36 months)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Италия · 24 центра

• 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
• … и ещё 16 центров

Идентификаторы

NCT: NCT07476105 · FIL_Elderly Project 2.0

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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