Impact of Chemotherapeutic Treatments in Patients Aged 75 Years and Over Treated for Lymphoid Hematological Malignancy — LYMPHOLD  

Lymphoma Clinical Trial

Official title: Impact of Chemotherapeutic Treatments on Functional Autonomy and Quality of Life in Patients Aged 75 Years and Over Treated for Lymphoid Hematological Malignancy

Status Recruiting

Clinical Trial Summary

The aim of the study is to assess the prevalence of functional decline in elderly patients treated with chemotherapy or immunochemotherapy for lymphoid hematologic malignancies. For this purpose, each patient benefits at inclusion (D0) of a standardized gerontological evaluation, and 3 and 6 months post-inclusion.

Clinical Trial Description

The aim of this study is to contribute to the improvement of the hematological management of elderly patients. Indeed, the majority of hematological malignancies are diagnosed in subjects aged 65 years and over. Hematologists are therefore increasingly confronted with the complexity of managing elderly patients. The high prevalence of comorbidities and/or geriatric syndromes (cognitive disorders, malnutrition, loss of functional autonomy, etc.) contributes to the great heterogeneity of this population and to the complexity of therapeutic decisions.

The comprehensive geriatric assessment (CGA), recommended by the International Society of of Onco-Geriatrics (SIOG), allows to better understand this heterogeneity and to define an individualized management. Numerous studies have demonstrated the value of the CGA in predicting the risk of treatment toxicity and morbidity in geriatric hematology. However, beyond life expectancy, the maintenance of quality of life and/or functional autonomy represent major parameters to be integrated into the therapeutic decision. These two parameters are not sufficiently taken into account in hematology clinical trials. In the vast majority of these studies, the criteria of interest remain purely hematological (overall survival, toxicity, relapse-free survival, etc.). This approach may even be responsible for an increased risk of toxicity when the chemotherapy protocols proposed to elderly patients are based on the same objectives as those for younger subjects. It therefore seems essential to change the paradigm by integrating major geriatric criteria into the methodology of clinical trials of hematological malignancies in elderly patients.

The main objective of our study is therefore to evaluate the prevalence of functional decline in a population of elderly patients treated with chemotherapy or immuno-chemotherapy for lymphoid hemopathies. For this purpose, each patient benefits at inclusion (D0) of a standardized gerontological evaluation, and 3 and 6 months post-inclusion. ;

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Lymphoma
• Multiple Myeloma
• Neoplasm, Plasma Cell
• Neoplasms, Plasma Cell

• NCT number: NCT05101759
• Study type: Interventional
• Source: University Hospital, Toulouse
• Contact: Laurent BALARDY, MD
• Phone: 05 61 77 64 95
• Email: balardy.l@chu-toulouse.fr
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Completion date: December 31, 2024