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

NCT05101759 | Completed

• 1 other identifier: RC31/20/0490
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasm, Plasma Cell; Lymphoma

Keywords

comprehensive geriatric assessment (CGA); quality of life (QoL); autonomy; elderly patients; chemotherapy; immunochemotherapy; lymphoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Functional performance

  6 months

• Toxicity assessed according to NCI-CTCAE v5

  6 months

• Institutionalization

  6 months

• Early death

  6 months

Study Arms (1)

Geriatric Follow-up (Comprehensive Geriatric Assessment)

OTHER

A systematic reassessment of geriatric parameters

Procedure: Comprehensive Geriatric Assessment

Interventions

Comprehensive Geriatric Assessment PROCEDURE

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

Geriatric Follow-up (Comprehensive Geriatric Assessment)

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead
• Institut Claudius Regaud: collaborator

Study Sites (1)

University Hospital Toulouse

Toulouse, France, 31059, France

Location

MeSH Terms

Conditions

Neoplasms, Plasma Cell; Lymphoma

Interventions

Geriatric Assessment

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Status; Demography; Population Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Laurent BALARDY, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: November 1, 2021
• Study Start: October 11, 2022
• Primary Completion: September 16, 2024
• Study Completion: September 16, 2024
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)