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

Primary Purpose

Neoplasm, Plasma Cell, Lymphoma

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Comprehensive Geriatric Assessment
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Neoplasm, Plasma Cell focused on measuring comprehensive geriatric assessment (CGA), quality of life (QoL), autonomy, elderly patients, chemotherapy, immunochemotherapy, lymphoma

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Hospital ToulouseRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Geriatric Follow-up (Comprehensive Geriatric Assessment)

Arm Description

A systematic reassessment of geriatric parameters

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
October 20, 2021
Last Updated
March 8, 2023
Sponsor
University Hospital, Toulouse
Collaborators
Institut Claudius Regaud
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1. Study Identification

Unique Protocol Identification Number
NCT05101759
Brief Title
Impact of Chemotherapeutic Treatments in Patients Aged 75 Years and Over Treated for Lymphoid Hematological Malignancy
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
Collaborators
Institut Claudius Regaud

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasm, Plasma Cell, Lymphoma
Keywords
comprehensive geriatric assessment (CGA), quality of life (QoL), autonomy, elderly patients, chemotherapy, immunochemotherapy, lymphoma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Geriatric Follow-up (Comprehensive Geriatric Assessment)
Arm Type
Other
Arm Description
A systematic reassessment of geriatric parameters
Intervention Type
Procedure
Intervention Name(s)
Comprehensive Geriatric Assessment
Intervention Description
A systematic reassessment of geriatric parameters will be performed at 3 and 6 months post-inclusion.
Primary Outcome Measure Information:
Title
Functional Decline
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Functional performance
Description
A loss of at least 1 point in the Short Physical Performance Battery (SPPB) score
Time Frame
6 months
Title
Toxicity assessed according to NCI-CTCAE v5
Description
Events of Toxicity will be assessed according to NCI-CTCAE v5
Time Frame
6 months
Title
Institutionalization
Description
Ratio of institutionalized patients to total patients
Time Frame
6 months
Title
Early death
Description
Ratio of the number of patients who died early
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laurent BALARDY, MD
Phone
05 61 77 64 95
Ext
+33
Email
balardy.l@chu-toulouse.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Sabine LE FLOCH
Email
lefloch.s@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurent BALARDY, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent BALARDY
Phone
05 61 77 64 95
Ext
+33
Email
balardy.l@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Laurent BALARDY
First Name & Middle Initial & Last Name & Degree
Stéphanie LOZANO
First Name & Middle Initial & Last Name & Degree
Loïc YSEBAERT
First Name & Middle Initial & Last Name & Degree
Aurore PERROT

12. IPD Sharing Statement

Plan to Share IPD
No

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

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