Patients With Diffuse Large B-cell Lymphoma Treated With CART-cellsQOLD CAR-TNCT04914091
Quality Of Life and Drug Use in Patients With CAR-T Cells
An observational study of Patients With Diffuse Large B-cell Lymphoma Treated With CART-cells, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
CAR-T cells are a major therapeutic innovation in the management of patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) in 3rd line or more. Kymriah® and Yescarta® are the first CAR-T with Marketing Authorization and coverage by the French Health Insurance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Diffuse Large B-cell Lymphoma Treated With CART-cells
- What is being tested?
- Semi-structured interviews and self-administered questionnaires
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 31 Mar 2021to 31 Jan 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with diffuse large B-cell lymphoma treated with CART-cells in the center during the inclusion period.
Who may be able to join
- Over 18 years old
- Eligible for treatment with CAR-T cells (outside any clinical trial) in an indication of DLBCL and for which treatment is scheduled
- Follow-up in the Hematology department of the Hospices Civils de Lyon
- Without major psychiatric disorder likely to interfere with the conduct of the study, in the opinion of the investigator
- Having given his non-opposition to participate in the study.
Who cannot join
- In an institution
- Under legal protection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hospices Civils de Lyon -Groupement Hospitalier Sud Service pharmaceutique, Unité de Pharmacie Clinique Oncologique
Pierre-Bénite, 69495
Catherine RIOUFOL, Pharm. D, 04 78 86 43 70 ext. +33, catherine.rioufol@chu-lyon.fr
Catherine RIOUFOL, Pharm. D
About this study
Official title: Pilot Study for Quality Of Life and Drug Use Assessment in Patients With CAR-T Cells
CAR-T cells are a major therapeutic innovation in the management of patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) in 3rd line or more. Kymriah® and Yescarta® are the first CAR-T with Marketing Authorization and coverage by the French Health Insurance. Their clinical interest has been demonstrated in non-comparative phase 1-2 trials.
The non-comparative design of the pivotal trials, the lack of data on patients' quality of life and drug consumption, as well as the very high cost of CAR-T (about € 320,000 for one treatment) warrant further studies.
This prospective non-comparative study aims to describe in real life the quality of life of patients treated with CAR-T cells, real world drug use and patients' experience feedback.
- Being tested
- Semi-structured interviews and self-administered questionnaires
- Keywords
- CAR-T cells, Quality of life, drug use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-structured interviews and self-administered questionnairesOther
Interviews and questionnaires will be performed before administration of CAR-T cells, 3 month after and 6 month after, and will last 60 minutes each time. Semi-structured interview using pre-established questionnaires will be completed with a hospital pharmacist, concerning the patient's perception of his family, socio-professional environment, his knowledge of his illness and his treatment, the consumption of prescribed drugs outside the hospital, self-medication, complementary alternative therapies including herbal medicine. Seven self-administered questionnaires will be completed, concerning quality of life, Assessment of Cancer Treatment-Lymphoma, Beliefs about Medicines, Brief Illness Perception, satisfaction with medication, perceived social support scale, and on Health Literacy.
| Study group | Role | What they receive |
|---|---|---|
| Patients with diffuse large B-cell lymphoma treated with CART-cells | Not described Receives: Other: Semi-structured interviews and self-administered questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Mean quality of life score using the EORTC-QLQ C30 questionnaire
Self-administered questionnaire EORTC-QLQ C30 (European Organisation for Research and Treatment of Cancer), developed to assess the quality of life of cancer patients, with 30 items. Score ranges from 0 (the worse) to 100 (the best).
Measured: Inclusion (the day before lymphodepletion chemotherapy), Month 3 and Month 6 after the administration of CART-T cells
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start31 Mar 2021
- Primary completion31 Jan 2033 (estimated)
- Study completion31 Jan 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Diffuse Large B-cell Lymphoma Treated With CART-cellsStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04914091
- Sponsor's protocol ID
- 69HCL20_1182
- Acronym
- QOLD CAR-T
- Status last verified
- Jan 2026
- First submitted
- 31 May 2021
- Last updated
- 28 Jan 2026
- 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 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for Quality Of Life and Drug Use Assessment in Patients With CAR-T Cells
- ClinicalTrials.gov ID
- NCT04914091
- Acronym / sponsor ID
- QOLD CAR-T / 69HCL20_1182
- Keywords
- CAR-T cells, Quality of life, drug use
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 31 Mar 2021 (actual)
- Primary completion
- 31 Jan 2033 (estimated)
- Study completion
- 31 Jan 2033 (estimated)
- First posted
- 4 Jun 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.
CAR-T cells are a major therapeutic innovation in the management of patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) in 3rd line or more. Kymriah® and Yescarta® are the first CAR-T with Marketing Authorization and coverage by the French Health Insurance. Their clinical interest has been demonstrated in non-comparative phase 1-2 trials.
The non-comparative design of the pivotal trials, the lack of data on patients' quality of life and drug consumption, as well as the very high cost of CAR-T (about € 320,000 for one treatment) warrant further studies.
This prospective non-comparative study aims to describe in real life the quality of life of patients treated with CAR-T cells, real world drug use and patients' experience feedback.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with diffuse large B-cell lymphoma treated with CART-cells | – | Other: Semi-structured interviews and self-administered questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diffuse large B-cell lymphoma treated with CART-cells in the center during the inclusion period.
Key inclusion criteria (5 listed)
- Over 18 years old
- Eligible for treatment with CAR-T cells (outside any clinical trial) in an indication of DLBCL and for which treatment is scheduled
- Follow-up in the Hematology department of the Hospices Civils de Lyon
- Without major psychiatric disorder likely to interfere with the conduct of the study, in the opinion of the investigator
- Having given his non-opposition to participate in the study.
Key exclusion criteria (2 listed)
- In an institution
- Under legal protection
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 |
|---|---|---|
| Semi-structured interviews and self-administered questionnairesInterviews and questionnaires will be performed before administration of CAR-T cells, 3 month after and 6 month after, and will last 60 minutes each time. Semi-structured interview using pre-established questionnaires will be completed with a hospital pharmacist, concerning the patient's perception of his family, socio-professional environment, his knowledge of his illness and his treatment, the consumption of prescribed drugs outside the hospital, self-medication, complementary alternative therapies including herbal medicine. Seven self-administered questionnaires will be completed, concerning quality of life, Assessment of Cancer Treatment-Lymphoma, Beliefs about Medicines, Brief Illness Perception, satisfaction with medication, perceived social support scale, and on Health Literacy. | Other | Patients with diffuse large B-cell lymphoma treated with CART-cells |
Primary outcome
Change of Mean quality of life score using the EORTC-QLQ C30 questionnaire
Time frame: Inclusion (the day before lymphodepletion chemotherapy), Month 3 and Month 6 after the administration of CART-T cells
Self-administered questionnaire EORTC-QLQ C30 (European Organisation for Research and Treatment of Cancer), developed to assess the quality of life of cancer patients, with 30 items. Score ranges from 0 (the worse) to 100 (the best).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients With Diffuse Large B-cell Lymphoma Treated With CART-cells, run by Hospices Civils de Lyon 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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 28 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Catherine RIOUFOL, Pharm. D (04 78 86 43 70 ext. +33, catherine.rioufol@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Mean quality of life score using the EORTC-QLQ C30 questionnaire (time frame: Inclusion (the day before lymphodepletion chemotherapy), Month 3 and Month 6 after the administration of CART-T cells). 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 28 Jan 2026.