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

Sponsor

University Hospital, Toulouse (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05101759

Collaborator

Institut Claudius Regaud (Other)

100

Enrollment

Location

Arm

12.9

Anticipated Duration (Months)

7.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Neoplasm, Plasma Cell Lymphoma	Procedure: Comprehensive Geriatric Assessment	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

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

Anticipated Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Functionnal Decline [6 months]
Rate of patients with functional decline at 6 months. Functional decline was defined as a loss of 0.5 points or more on the ADL at 6 months compared with inclusion.

Secondary Outcome Measures

Functional performance [6 months]
A loss of at least 1 point in the SPPB score
Toxicity assessed according to NCI-CTCAE v5 [6 months]
Events of Toxicity will be assessed according to NCI-CTCAE v5
Institutionalization [6 months]
Ratio of institutionalized patients to total patients
Early death [6 months]
Ratio of the number of patients who died early

Eligibility Criteria

Criteria

Ages Eligible for Study:

75 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).
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 curatorship