Neoplasm, Plasma CellLYMPHOLDNCT05101759
Impact of Chemotherapeutic Treatments in Patients Aged 75 Years and Over Treated for Lymphoid Hematological Malignancy
A study testing Comprehensive Geriatric Assessment in people with Neoplasm, Plasma Cell and Lymphoma, run by University Hospital, Toulouse at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Neoplasm, Plasma Cell, Lymphoma
- What is being tested?
- Comprehensive Geriatric Assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 11 Oct 2022to 16 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Neoplasm, Plasma Cell, Lymphoma
- Being tested
- Comprehensive Geriatric Assessment
- Keywords
- comprehensive geriatric assessment (CGA), quality of life (QoL), autonomy, elderly patients, chemotherapy, immunochemotherapy, lymphoma
- Medical subject headings
- Neoplasms, Plasma Cell, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Geriatric AssessmentProcedure or surgery
A systematic reassessment of geriatric parameters will be performed at 3 and 6 months post-inclusion.
| Study group | Role | What they receive |
|---|---|---|
| Geriatric Follow-up (Comprehensive Geriatric Assessment) | Other | A systematic reassessment of geriatric parameters Receives: Procedure: Comprehensive Geriatric Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (4)
Functional performance
A loss of at least 1 point in the Short Physical Performance Battery (SPPB) score
Measured: 6 months
Toxicity assessed according to NCI-CTCAE v5
Events of Toxicity will be assessed according to NCI-CTCAE v5
Measured: 6 months
Institutionalization
Ratio of institutionalized patients to total patients
Measured: 6 months
Early death
Ratio of the number of patients who died early
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study start11 Oct 2022
- Primary completion16 Sep 2024
- Study completion16 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasm, Plasma CellStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Claudius Regaud
- Responsible party
- Sponsor
- Investigators
- Laurent BALARDY, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05101759
- Sponsor's protocol ID
- RC31/20/0490
- Acronym
- LYMPHOLD
- Status last verified
- Sep 2024
- First submitted
- 20 Oct 2021
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05101759
- Acronym / sponsor ID
- LYMPHOLD / RC31/20/0490
- Conditions
- Neoplasm, Plasma Cell, Lymphoma
- Keywords
- comprehensive geriatric assessment (CGA), quality of life (QoL), autonomy, elderly patients, chemotherapy, immunochemotherapy, lymphoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Institut Claudius Regaud
- Study start
- 11 Oct 2022 (actual)
- Primary completion
- 16 Sep 2024 (actual)
- Study completion
- 16 Sep 2024 (actual)
- First posted
- 1 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Geriatric Follow-up (Comprehensive Geriatric Assessment) | Other | Procedure: Comprehensive Geriatric AssessmentA systematic reassessment of geriatric parameters |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive Geriatric AssessmentA systematic reassessment of geriatric parameters will be performed at 3 and 6 months post-inclusion. | Procedure or surgery | Geriatric Follow-up (Comprehensive Geriatric Assessment) |
Primary outcome
Functional Decline
Time frame: 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 Activities Daily Living scale (ADL) at 6 months compared with inclusion.
4 secondary outcomes
Functional performance
Time frame: 6 months
Toxicity assessed according to NCI-CTCAE v5
Time frame: 6 months
Institutionalization
Time frame: 6 months
Early death
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent BALARDY, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive Geriatric Assessment in people with Neoplasm, Plasma Cell and Lymphoma, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Decline (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.