Diffuse Large B-Cell Lymphoma (DLBCL)NCT05349201
CAR T Cells Real World Evidence Study Based on the French Hospital Claims Data Source (PMSI)
An observational study of Diffuse Large B-Cell Lymphoma (DLBCL) and Acute Lymphoblastic Leukemia (ALL), run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
This was a Retrospective cohort study based on the PMSI data source Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Diffuse Large B-Cell Lymphoma (DLBCL), Acute Lymphoblastic Leukemia (ALL)
- What is being tested?
- KYMRIAH and YESCARTA
- How many people
- 273 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2020to 28 May 2021
- 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 to 30 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients ( ≥18 years of age) with (relapsed/refractory diffuse large B cell lymphoma [R/R DLBCL]), currently being treated in third line or more with * KYMRIAH * YESCARTA Pediatric and young adult patients (≤25 years of age) with B cell acute lymphoblastic leukemia ( refractory, in relapse post transplant or in second or later relapse, currently being treated in third line or higher with • KYMRIAH
Who may be able to join
- Patients treated with CAR-T cells from 2017 to 2019 and informed as such in the PMSI And
- Patients diagnosed with ALL or DLBCL when administering CAR-T cells and
- up to 25 years for patients with ALL
Who cannot join
- All patients treated outside the two types of indications presented in the inclusion criteria will be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Investigative Site
East Hanover, New Jersey, 07936-1080
About this study
Official title: CAR-T Cells - Real Life Study Of Care Pathway And Total Cost Of Care For Patients Under Car T-Cell Treatment Based On The PMSI French Database
This was a Retrospective cohort study based on the PMSI data source
Read the detailed description
A retrospective database analysis was performed using the French national hospital claims database (Medicalized Information System Program - PMSI, 2015-2019), which includes discharge summaries for all hospital admissions in France (~99% of French residents).
The patients were identified based on the CAR-T administration hospital stay, between 2017 and 2019. Based on the exhaustivity of the database, all patients treated with CAR-T (since 2018) were identified.
The study design included multiple periods of analysis based on the CAR-T process. Three main periods were defined: the historical period, the CAR-T period, and the post CAR-T period. The CAR-T period was divided in 2 sub-periods: pre CAR-T (including the apheresis procedure and 15 days before this procedure) and per CAR-T (including the lymphodepletion and CAR-T cell injection hospital stay until the end at the discharge date related to CAR-T cell injection hospital stay). The follow-up period started at the end of CAR-T hospital stay.
CAR-T populations:
KYMRIAH® DLBCL cohort:
- Adult patients (≥18 years of age) with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.
- Patient with a CAR-T administration hospital stay of Kymriah between 2017 and 2019
YESCARTA®DLBCL cohort:
- Adult patients (≥18 years of age) with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy:
- Patient with a CAR-T administration hospital stay of Yescarta between 2017 and 2019
KYMRIAH® ALL cohort:
- Pediatric and young adult patients (≤ 25 years of age) with B-cell acute lymphoblastic leukemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse:
- Patient with a CAR-T administration hospital stay of Kymriah between 2017 and 2019
- Being tested
- KYMRIAH, YESCARTA
- 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.
KYMRIAHOther
Patients (≥18 years of age) with (relapsed/refractory diffuse large B cell lymphoma [R/R DLBCL]) or Pediatric and young adult patients (≤25 years of age) with B cell acute lymphoblastic leukemia (ALL) refractory, in relapse post transplant or in second or later relapse
YESCARTAOther
Patients (≥18 years of age) with (relapsed/refractory diffuse large B cell lymphoma [R/R DLBCL])
| Study group | Role | What they receive |
|---|---|---|
| Adult R/R DLBCL cohort: KYMRIAH | Patients (≥18 years of age) with (relapsed/refractory diffuse large B cell lymphoma [R/R DLBCL]) Receives: Other: KYMRIAH | |
| Adult R/R DLBCL cohort: YESCARTA | Patients (≥18 years of age) with (relapsed/refractory diffuse large B cell lymphoma [R/R DLBCL]) Receives: Other: YESCARTA | |
| ALL pediatric and young adult cohort: KYMRIAH | Pediatric and young adult patients (≤25 years of age) with B cell acute lymphoblastic leukemia (ALL) ( refractory, in relapse post transplant or in second or later relapse Receives: Other: KYMRIAH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival: number of events
Overall survival indicator was defined as all cause death recorded at the hospital (MSO, HAD, SSR). Patients were censored at the date of last hospitalization observed (MSO/HAD/SSR/ACE).
Measured: through study completion, approximately 2 years (January 2017 to December 2019)
Time to next treatment (TTNT) analysis: number of events
Time to next treatment indicator was defined as the time between CAR-T injection and the date of the hospitalization or palliative care.
Measured: through study completion, approximately 2 years (January 2017 to December 2019)
Time to next treatment (TTNT) or death analysis: number of events
Time to next treatment or death indicator was defined as the first event occurring between TNTT or death presented during the hospitalization or palliative care.
Measured: through study completion, approximately 2 years (January 2017 to December 2019)
Follow-up time between the CAR-T injection and the last hospital stay observed
Follow-up is the time between the CAR-T injection (index date) and the last hospital stay observed.
Measured: through study completion, approximately 2 years (January 2017 to December 2019)
Overall cost for CAR-T hospitalization
The CAR-T hospitalization included Medical, Surgical, Obstetrics (MSO) hospitalization tariff and extra tariff linked to CAR-T treatment reimbursed by the health care insurance
Measured: through study completion, approximately 2 years (January 2017 to December 2019)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start9 Dec 2020
- Primary completion28 May 2021
- Study completion28 May 2021
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 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
- 273 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
- NCT05349201
- Sponsor's protocol ID
- CCTL019A0FR02
- Status last verified
- Jun 2022
- First submitted
- 6 Apr 2022
- Last updated
- 1 Jul 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAR-T Cells - Real Life Study Of Care Pathway And Total Cost Of Care For Patients Under Car T-Cell Treatment Based On The PMSI French Database
- ClinicalTrials.gov ID
- NCT05349201
- Acronym / sponsor ID
- CCTL019A0FR02
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 273 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 9 Dec 2020 (actual)
- Primary completion
- 28 May 2021 (actual)
- Study completion
- 28 May 2021 (actual)
- First posted
- 27 Apr 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.
This was a Retrospective cohort study based on the PMSI data source
Detailed description
A retrospective database analysis was performed using the French national hospital claims database (Medicalized Information System Program - PMSI, 2015-2019), which includes discharge summaries for all hospital admissions in France (~99% of French residents).
The patients were identified based on the CAR-T administration hospital stay, between 2017 and 2019. Based on the exhaustivity of the database, all patients treated with CAR-T (since 2018) were identified.
The study design included multiple periods of analysis based on the CAR-T process. Three main periods were defined: the historical period, the CAR-T period, and the post CAR-T period. The CAR-T period was divided in 2 sub-periods: pre CAR-T (including the apheresis procedure and 15 days before this procedure) and per CAR-T (including the lymphodepletion and CAR-T cell injection hospital stay until the end at the discharge date related to CAR-T cell injection hospital stay). The follow-up period started at the end of CAR-T hospital stay.
CAR-T populations:
KYMRIAH® DLBCL cohort:
- Adult patients (≥18 years of age) with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.
- Patient with a CAR-T administration hospital stay of Kymriah between 2017 and 2019
YESCARTA®DLBCL cohort:
- Adult patients (≥18 years of age) with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy:
- Patient with a CAR-T administration hospital stay of Yescarta between 2017 and 2019
KYMRIAH® ALL cohort:
- Pediatric and young adult patients (≤ 25 years of age) with B-cell acute lymphoblastic leukemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse:
- Patient with a CAR-T administration hospital stay of Kymriah between 2017 and 2019
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adult R/R DLBCL cohort: KYMRIAH | – | Other: KYMRIAHPatients (≥18 years of age) with (relapsed/refractory diffuse large B cell lymphoma [R/R DLBCL]) |
| Adult R/R DLBCL cohort: YESCARTA | – | Other: YESCARTAPatients (≥18 years of age) with (relapsed/refractory diffuse large B cell lymphoma [R/R DLBCL]) |
| ALL pediatric and young adult cohort: KYMRIAH | – | Other: KYMRIAHPediatric and young adult patients (≤25 years of age) with B cell acute lymphoblastic leukemia (ALL) ( refractory, in relapse post transplant or in second or later relapse |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients ( ≥18 years of age) with (relapsed/refractory diffuse large B cell lymphoma [R/R DLBCL]), currently being treated in third line or more with * KYMRIAH * YESCARTA Pediatric and young adult patients (≤25 years of age) with B cell acute lymphoblastic leukemia ( refractory, in relapse post transplant or in second or later relapse, currently being treated in third line or higher with • KYMRIAH
Key inclusion criteria (3 listed)
- Patients treated with CAR-T cells from 2017 to 2019 and informed as such in the PMSI And
- Patients diagnosed with ALL or DLBCL when administering CAR-T cells and
- up to 25 years for patients with ALL
Key exclusion criteria (1 listed)
- All patients treated outside the two types of indications presented in the inclusion criteria will be excluded
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 |
|---|---|---|
| KYMRIAHPatients (≥18 years of age) with (relapsed/refractory diffuse large B cell lymphoma [R/R DLBCL]) or Pediatric and young adult patients (≤25 years of age) with B cell acute lymphoblastic leukemia (ALL) refractory, in relapse post transplant or in second or later relapse | Other | ALL pediatric and young adult cohort: KYMRIAH, Adult R/R DLBCL cohort: KYMRIAH |
| YESCARTAPatients (≥18 years of age) with (relapsed/refractory diffuse large B cell lymphoma [R/R DLBCL]) | Other | Adult R/R DLBCL cohort: YESCARTA |
Primary outcome
Overall survival: number of events
Time frame: through study completion, approximately 2 years (January 2017 to December 2019)
Overall survival indicator was defined as all cause death recorded at the hospital (MSO, HAD, SSR). Patients were censored at the date of last hospitalization observed (MSO/HAD/SSR/ACE).
Time to next treatment (TTNT) analysis: number of events
Time frame: through study completion, approximately 2 years (January 2017 to December 2019)
Time to next treatment indicator was defined as the time between CAR-T injection and the date of the hospitalization or palliative care.
Time to next treatment (TTNT) or death analysis: number of events
Time frame: through study completion, approximately 2 years (January 2017 to December 2019)
Time to next treatment or death indicator was defined as the first event occurring between TNTT or death presented during the hospitalization or palliative care.
Follow-up time between the CAR-T injection and the last hospital stay observed
Time frame: through study completion, approximately 2 years (January 2017 to December 2019)
Follow-up is the time between the CAR-T injection (index date) and the last hospital stay observed.
Overall cost for CAR-T hospitalization
Time frame: through study completion, approximately 2 years (January 2017 to December 2019)
The CAR-T hospitalization included Medical, Surgical, Obstetrics (MSO) hospitalization tariff and extra tariff linked to CAR-T treatment reimbursed by the health care insurance
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 1 Jul 2022.
- Results for CCTL019A0FR02 from the Novartis Clinical Trials Results DatabaseLink provided by the sponsor.
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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 (DLBCL) and Acute Lymphoblastic Leukemia (ALL), run by Novartis Pharmaceuticals at 1 site in United States.
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 3 inclusion and 1 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 1 Jul 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 United States. 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?
Overall survival: number of events (time frame: through study completion, approximately 2 years (January 2017 to December 2019)). The study lists 5 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 1 Jul 2022; AzTrials last refreshed its copy on 1 Nov 2026.