Diffuse Large B-cell LymphomaNCT06392763
Care Pathway and Associated Costs of Patients Treated With CAR T-cells Based on SNDS Data
An observational study of Diffuse Large B-cell Lymphoma and Acute Lymphoblastic Leukemia (ALL), run by Novartis Pharmaceuticals at 1 site in France.
Trial summary
This retrospective cohort study, based on the French medico-administrative database (SNDS), evaluated the care pathway, the effectiveness of management and the costs associated with patients treated with chimeric antigen receptor (CAR) T cells (CART-cells) (KYMRIAH or YESCARTA): paediatric and young adult patients (up… Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Diffuse Large B-cell Lymphoma, Acute Lymphoblastic Leukemia (ALL)
- How many people
- 602 participants
- Where
- 1 siteFrance
- Study dates
- 3 Aug 2021to 28 Apr 2023
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This was a retrospective, noninterventional cohort study
Who may be able to join
- DLBCL population:
- Patients with hospitalisation for CAR T-cell administration from 2017 to 2020 AND
- Diagnosed with DLBCL (International Classification of Diseases [ICD-10 C833]) when receiving CAR-T AND
- Being 18 years of age or older.
- ALL population:
- Patients with hospitalisation for CAR T-cell administration from 2017 to 2020 AND
- Diagnosed with ALL (ICD-10 C910) when receiving CAR-T AND
- Being 25 years of age or younger.
Who cannot join
- DLBCL population:
- Patients hospitalised with a diagnosis other than DLBCL during the historical period or during the index stay.
- ALL population:
- Patients hospitalised with a diagnosis other than ALL during the historical period or during the index stay.
Trial locations and contacts
1 site in 1 country.
About this study
This retrospective cohort study, based on the French medico-administrative database (SNDS), evaluated the care pathway, the effectiveness of management and the costs associated with patients treated with chimeric antigen receptor (CAR) T cells (CART-cells) (KYMRIAH or YESCARTA): paediatric and young adult patients (up to and including 25 years of age) with acute lymphoblastic leukaemia (ALL); and adult patients (18 years of age or older) with DLBCL.
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| KYMRIAH DLBCL | Not described | |
| YESCARTA DLBCL | Not described | |
| CAR-T DLBCL | Not described | |
| KYMRIAH ALL | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of medicine, surgery, obstetrics and odontology (MCO) stays per patient
Measured: Up to 36 months
Number of outpatient visit (ACE) stays per patient
Measured: Up to 36 months
Number of emergency room visits not followed by hospitalisation per patient
Measured: Up to 36 months
Number of aftercare and rehabilitation (SSR) stays per patient
Measured: Up to 36 months
Number of homecare (HAD) stays per patient
Measured: Up to 36 months
Number of consultations per type of healthcare professional
Measured: Up to 36 months
Number of consultations per patient (all consultations combined)
Measured: Up to 36 months
Number of patients who died
Measured: Up to 36 months
Cost of MCO hospitalisation
Measured: Up to 36 months
Cost of CAR-T on the supplementary list
Measured: Up to 36 months
Cost of medicines on the supplementary list (excluding CAR-T)
Measured: Up to 36 months
Hospitalisation cost
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start3 Aug 2021
- Primary completion28 Apr 2023
- Study completion28 Apr 2023
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 LymphomaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Retrospective
- Enrolment
- 602 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06392763
- Sponsor's protocol ID
- CCTL019A0FR03
- Status last verified
- Apr 2024
- First submitted
- 26 Apr 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Care Pathway and Associated Costs of Patients Treated With CAR T-cells Based on SNDS Data
- ClinicalTrials.gov ID
- NCT06392763
- Acronym / sponsor ID
- CCTL019A0FR03
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 602 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 3 Aug 2021 (actual)
- Primary completion
- 28 Apr 2023 (actual)
- Study completion
- 28 Apr 2023 (actual)
- First posted
- 30 Apr 2024 (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.
This retrospective cohort study, based on the French medico-administrative database (SNDS), evaluated the care pathway, the effectiveness of management and the costs associated with patients treated with chimeric antigen receptor (CAR) T cells (CART-cells) (KYMRIAH or YESCARTA): paediatric and young adult patients (up to and including 25 years of age) with acute lymphoblastic leukaemia (ALL); and adult patients (18 years of age or older) with DLBCL.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| KYMRIAH DLBCL | – | – |
| YESCARTA DLBCL | – | – |
| CAR-T DLBCL | – | – |
| KYMRIAH ALL | – | – |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This was a retrospective, noninterventional cohort study
Key inclusion criteria (8 listed)
- Patients with hospitalisation for CAR T-cell administration from 2017 to 2020 AND
- Diagnosed with DLBCL (International Classification of Diseases [ICD-10 C833]) when receiving CAR-T AND
- Being 18 years of age or older.
- Patients with hospitalisation for CAR T-cell administration from 2017 to 2020 AND
- Diagnosed with ALL (ICD-10 C910) when receiving CAR-T AND
Key exclusion criteria (4 listed)
- Patients hospitalised with a diagnosis other than DLBCL during the historical period or during the index stay.
- Patients hospitalised with a diagnosis other than ALL during the historical period or during the index stay.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of medicine, surgery, obstetrics and odontology (MCO) stays per patient
Time frame: Up to 36 months
Number of outpatient visit (ACE) stays per patient
Time frame: Up to 36 months
Number of emergency room visits not followed by hospitalisation per patient
Time frame: Up to 36 months
Number of aftercare and rehabilitation (SSR) stays per patient
Time frame: Up to 36 months
Number of homecare (HAD) stays per patient
Time frame: Up to 36 months
Number of consultations per type of healthcare professional
Time frame: Up to 36 months
Number of consultations per patient (all consultations combined)
Time frame: Up to 36 months
Number of patients who died
Time frame: Up to 36 months
Cost of MCO hospitalisation
Time frame: Up to 36 months
Cost of CAR-T on the supplementary list
Time frame: Up to 36 months
Cost of medicines on the supplementary list (excluding CAR-T)
Time frame: Up to 36 months
Hospitalisation cost
Time frame: Up to 36 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 30 Apr 2024.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
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 and Acute Lymphoblastic Leukemia (ALL), run by Novartis Pharmaceuticals 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 8 inclusion and 4 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 30 Apr 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?
Number of medicine, surgery, obstetrics and odontology (MCO) stays per patient (time frame: Up to 36 months). The study lists 12 primary outcomes in all. 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 30 Apr 2024.