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

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

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.

Study Overview

• Status: Completed
• Conditions: Lymphoma; Neoplasm, Plasma Cell
• Intervention / Treatment: Procedure: Comprehensive Geriatric Assessment

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31059
    • University Hospital Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Geriatric Follow-up (Comprehensive Geriatric Assessment); A systematic reassessment of geriatric parameters	Procedure: Comprehensive Geriatric Assessment; A systematic reassessment of geriatric parameters will be performed at 3 and 6 months post-inclusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Toxicity assessed according to NCI-CTCAE v5	Events of Toxicity will be assessed according to NCI-CTCAE v5	6 months
Institutionalization	Ratio of institutionalized patients to total patients	6 months
Early death	Ratio of the number of patients who died early	6 months
Functional performance	A loss of at least 1 point in the Short Physical Performance Battery (SPPB) score	6 months

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Collaborators: Institut Claudius Regaud
• Investigators: Principal Investigator: Laurent BALARDY, MD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2022
• Primary Completion (Actual): September 16, 2024
• Study Completion (Actual): September 16, 2024

Study Registration Dates

• First Submitted: October 20, 2021
• First Submitted That Met QC Criteria: October 20, 2021
• First Posted (Actual): November 1, 2021

Study Record Updates

• Last Update Posted (Actual): September 25, 2024
• Last Update Submitted That Met QC Criteria: September 23, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: lymphoma; chemotherapy; immunochemotherapy; elderly patients; quality of life (QoL); autonomy; comprehensive geriatric assessment (CGA)
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms by Site; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hematologic Neoplasms; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: RC31/20/0490

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No