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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	75 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Male or female 75 years of age or older, - Lymphoid hemopathies (diffuse large cell B-cell lymphoma (DLBCL), follicular lymphoma, marginal zone lymphoma, Hodgkin's lymphoma and T-cell lymphoma, chronic lymphocytic leukemia (CLL)) or plasma cell and/or lymphoplasmacytic hemopathies (multiple myeloma or Waldenström disease).

- World Health Organization (WHO) performance index 0-3, - Patients requiring first or second line chemotherapy and/or immunotherapy associated or not to targeted therapy, - Patients with a life expectancy of more than 3 months, - Persons affiliated or benefiting from a social insurance, - Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).

Exclusion Criteria:

- Myeloid hemopathies, - Patient included in a clinical trial that potentially interferes with the purpose of the study (geriatric interventional study, early drug study), - Patient under court protection, guardianship or curator

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05101759
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University Hospital, Toulouse
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Laurent BALARDY, MD
Principal Investigator Affiliation	University Hospital, Toulouse
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Neoplasm, Plasma Cell, Lymphoma

Additional Details

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.

Arms & Interventions

Arms

Other: Geriatric Follow-up (Comprehensive Geriatric Assessment)

A systematic reassessment of geriatric parameters

Interventions

Procedure: - Comprehensive Geriatric Assessment

A systematic reassessment of geriatric parameters will be performed at 3 and 6 months post-inclusion.

Contact a Trial Team

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International Sites

University Hospital Toulouse, Toulouse, France

Status

Recruiting

Address

University Hospital Toulouse

Toulouse, , 31059

Site Contact

Laurent BALARDY

balardy.l@chu-toulouse.fr

05 61 77 64 95 #+33

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