Diffuse Large B-cell Lymphoma (DLBCL)QUALITOP CAR-TNCT05532761
Multidimensional Assessment of Quality of Life, Social and Professional Life and Care Utilization in Patients With Diffuse Large Cell B-cell Lymphoma Treated With CAR-T Cells
An observational study of Diffuse Large B-cell Lymphoma (DLBCL) and CAR-T Cells Treatment, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Immunotherapy became in recent years a major innovation in the care of cancer patients, with unprecedented improvement in complete response and survival, particularly in hematological cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B-cell Lymphoma (DLBCL), CAR-T Cells Treatment
- What is being tested?
- self-administered questionnaires
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2022to Mar 2025
- Phase
- Observational
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with diffuse large cell B-cell lymphoma followed in the hematology department of Pr GUESQUIERES (Pierre-Bénite, France) whose treatment with CAR-T cells is planned will be offered participation in the QUALITOP CAR-T study. The number of patients with DLBCL benefiting annually from treatment with CAR-T cells in hematologic department is around 55. The number of subjects to be included, estimated at 30 patients over one year, is therefore compatible with the recruitment
Who may be able to join
- over 18 years old
- eligible for treatment with CAR-Tcells (outside a clinical trial) in an indication of diffuse large B-cell lymphoma for which treatment with CAR-Tcells is scheduled
- follow-up in the Hematology department of the Hospices Civils de Lyon (Pr. Hervé Ghesquières)
- having given their non-objection to participate in the study.
Who cannot join
- Adults subject to a measure of legal protection (curatorship, guardianship)
- Persons deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care and persons admitted to a health or social establishment
- People with a major psychiatric disorder likely to hinder the conduct of the study, in the opinion of the investigator
- Not fluent in French-
- simultaneous participation in another research involving the human person, except if it is a study falling within category 3 of the Jardé Law which does not call into question the follow-up of patients in the present study.
Trial locations and contacts
1 site in 1 country.
France1 site
Service pharmaceutique, Hospices Civils de Lyon - Groupement Hospitalier Sud
Pierre-Bénite, 69495
Magali MAIRE, Ph D, (0)478864334 ext. +33, magali.maire@chu-lyon.fr
Catherine RIOUFOL, Pharm D
About this study
Immunotherapy became in recent years a major innovation in the care of cancer patients, with unprecedented improvement in complete response and survival, particularly in hematological cancers. Since 2018, patients with relapsed or refractory lymphoma can benefit from immunotherapy based on CAR-T cells (Chimeric Antigenic Receptor - T cells), drugs derived from gene therapy and products from the patient's own T cells. The efficacy of these drugs, their development in more and more indications and in continuous earlier lines of treatment, their unprecedented adverse effects and their very high cost justify the search for predictive factors of efficacy and tolerance in order to optimize their use and benefit the greatest number of eligible patients. A better understanding of quality of life and its determinants in patients who received CAR-T cells could play a major role in predicting efficacy and tolerance. Quality of life data have indeed been deemed insufficient in phase 1-2 trials which have demonstrated the benefit of CAR-T cells in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in 3rd line of treatment or more and led to obtaining their marketing authorization. It is therefore necessary to assess the quality of life of patients treated in routine care with CAR-T cells. The European Qualitop project aims, from self-questionnaires, to explore the quality of life during the 2 years following the initiation of immunotherapy with a multidimensional approach integrating genetic factors, lifestyle habits and psychosocial determinants of patients. In this context, the Qualitop CAR-T study is a prospective non-comparative real-life study aimed at describing the multidimensional quality of life, its psychosocial determinants and drug consumption in patients with relapsed or refractory DLBCL treated with CAR -T cells.
- Being tested
- self-administered questionnaires
- Keywords
- Diffuse large B-cell lymphoma (DLBCL), CAR-T cells, Quality of life, Real-life
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-administered questionnairesOther
In order to describe the experience of CAR-T cell therapy of DLBCL patients, a pharmaceutical follow-up is carried out the day before the injection (baseline) and at 1, 3, 6, 9, 12 and 18 months. These follow-ups consist of interviews with the patient and the delivery of self-administered questionnaires. The interviews will investigate drug consumption, the use of self-medication and complementary alternative therapies and the adverse effects of interest. The self-questionnaires will focus on exploring multidimensional quality of life, social and professional life, anxiety-depression or uncertainty tolerance through internationally validated questionnaires.
No supplementary visits will be needed : interviews with the research team will occur at the end of hematologic consultations.
| Study group | Role | What they receive |
|---|---|---|
| diffuse lare B cells lymphoma | Diffuse large B cells lymphoma patients eligibles for CAR-T cells therapy Receives: Other: self-administered questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of mean score of FACT-Lym (Functional Assessment of Cancer Therapy - Lymphoma) quality of life
Measured: Baseline (day before chemotherapy of lymphodepletion), Month1, 3, 6, 9, 12 and 18 after injection of CAR-T cells
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study startSep 2022 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-cell Lymphoma (DLBCL)Studies 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
- 30 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
- NCT05532761
- Sponsor's protocol ID
- 69HCL22_0430
- Acronym
- QUALITOP CAR-T
- Status last verified
- Sep 2022
- First submitted
- 5 Sep 2022
- Last updated
- 8 Sep 2022
- 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 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidimensional Assessment of Quality of Life, Social and Professional Life and Care Utilization in Patients With Diffuse Large Cell B-cell Lymphoma Treated With CAR-T Cells
- ClinicalTrials.gov ID
- NCT05532761
- Acronym / sponsor ID
- QUALITOP CAR-T / 69HCL22_0430
- Keywords
- Diffuse large B-cell lymphoma (DLBCL), CAR-T cells, Quality of life, Real-life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 8 Sep 2022 (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.
Immunotherapy became in recent years a major innovation in the care of cancer patients, with unprecedented improvement in complete response and survival, particularly in hematological cancers. Since 2018, patients with relapsed or refractory lymphoma can benefit from immunotherapy based on CAR-T cells (Chimeric Antigenic Receptor - T cells), drugs derived from gene therapy and products from the patient's own T cells. The efficacy of these drugs, their development in more and more indications and in continuous earlier lines of treatment, their unprecedented adverse effects and their very high cost justify the search for predictive factors of efficacy and tolerance in order to optimize their use and benefit the greatest number of eligible patients. A better understanding of quality of life and its determinants in patients who received CAR-T cells could play a major role in predicting efficacy and tolerance. Quality of life data have indeed been deemed insufficient in phase 1-2 trials which have demonstrated the benefit of CAR-T cells in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in 3rd line of treatment or more and led to obtaining their marketing authorization. It is therefore necessary to assess the quality of life of patients treated in routine care with CAR-T cells. The European Qualitop project aims, from self-questionnaires, to explore the quality of life during the 2 years following the initiation of immunotherapy with a multidimensional approach integrating genetic factors, lifestyle habits and psychosocial determinants of patients. In this context, the Qualitop CAR-T study is a prospective non-comparative real-life study aimed at describing the multidimensional quality of life, its psychosocial determinants and drug consumption in patients with relapsed or refractory DLBCL treated with CAR -T cells.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| diffuse lare B cells lymphoma | – | Other: self-administered questionnairesDiffuse large B cells lymphoma patients eligibles for CAR-T cells therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with diffuse large cell B-cell lymphoma followed in the hematology department of Pr GUESQUIERES (Pierre-Bénite, France) whose treatment with CAR-T cells is planned will be offered participation in the QUALITOP CAR-T study. The number of patients with DLBCL benefiting annually from treatment with CAR-T cells in hematologic department is around 55. The number of subjects to be included, estimated at 30 patients over one year, is therefore compatible with the recruitment
Key inclusion criteria (4 listed)
- over 18 years old
- eligible for treatment with CAR-Tcells (outside a clinical trial) in an indication of diffuse large B-cell lymphoma for which treatment with CAR-Tcells is scheduled
- follow-up in the Hematology department of the Hospices Civils de Lyon (Pr. Hervé Ghesquières)
- having given their non-objection to participate in the study.
Key exclusion criteria (5 listed)
- Adults subject to a measure of legal protection (curatorship, guardianship)
- Persons deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care and persons admitted to a health or social establishment
- People with a major psychiatric disorder likely to hinder the conduct of the study, in the opinion of the investigator
- Not fluent in French-
- simultaneous participation in another research involving the human person, except if it is a study falling within category 3 of the Jardé Law which does not call into question the follow-up of patients in the present study.
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 |
|---|---|---|
| self-administered questionnairesIn order to describe the experience of CAR-T cell therapy of DLBCL patients, a pharmaceutical follow-up is carried out the day before the injection (baseline) and at 1, 3, 6, 9, 12 and 18 months. These follow-ups consist of interviews with the patient and the delivery of self-administered questionnaires. The interviews will investigate drug consumption, the use of self-medication and complementary alternative therapies and the adverse effects of interest. The self-questionnaires will focus on exploring multidimensional quality of life, social and professional life, anxiety-depression or uncertainty tolerance through internationally validated questionnaires. No supplementary visits will be needed : interviews with the research team will occur at the end of hematologic consultations. | Other | diffuse lare B cells lymphoma |
Primary outcome
Change of mean score of FACT-Lym (Functional Assessment of Cancer Therapy - Lymphoma) quality of life
Time frame: Baseline (day before chemotherapy of lymphodepletion), Month1, 3, 6, 9, 12 and 18 after injection of CAR-T cells
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
- 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.
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 Diffuse Large B-cell Lymphoma (DLBCL) and CAR-T Cells Treatment, 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 8 Sep 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Catherine RIOUFOL, Pharm D ((0)478864368 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 score of FACT-Lym (Functional Assessment of Cancer Therapy - Lymphoma) quality of life (time frame: Baseline (day before chemotherapy of lymphodepletion), Month1, 3, 6, 9, 12 and 18 after injection of CAR-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 8 Sep 2022.