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

Lymphoma Clinical Trial

— LYMPHOLD  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05101759
• Other study ID #: RC31/20/0490
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: University Hospital, Toulouse
• Contact: Laurent BALARDY, MD
• Phone: 05 61 77 64 95
• Email: balardy.l[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Comprehensive Geriatric Assessment
A systematic reassessment of geriatric parameters will be performed at 3 and 6 months post-inclusion.

Locations

Country	Name	City	State
France	University Hospital Toulouse	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Toulouse	Institut Claudius Regaud

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Decline	Rate of patients with functional decline at 6 months. Functional decline was defined as a loss of 0.5 points or more on the Activities Daily Living scale (ADL) at 6 months compared with inclusion.	6 months
Secondary	Functional performance	A loss of at least 1 point in the Short Physical Performance Battery (SPPB) score	6 months
Secondary	Toxicity assessed according to NCI-CTCAE v5	Events of Toxicity will be assessed according to NCI-CTCAE v5	6 months
Secondary	Institutionalization	Ratio of institutionalized patients to total patients	6 months
Secondary	Early death	Ratio of the number of patients who died early	6 months