Diffuse Large B-cell LymphomaNCT06271369
Real-World HRU and Costs in DLBCL Pts With Tisa-cel and Axi-cel, a Medicare Study.
An observational study of Diffuse Large B-cell Lymphoma, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
This was a retrospective non-interventional cohort study design using the Centers for Medicare and Medicaid Services (CMS) 100% Medicare data (2015Q1-2020Q4). Eligible adult patients with r/r DLBCL who were treated with CAR-T therapy were identified from the CMS 100% Medicare data. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B-cell Lymphoma
- How many people
- 613 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2022to 15 Feb 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This was a retrospective, noninterventional cohort study.
Who may be able to join
- Patients had at least one International Classification of Diseases, 10th Revision (ICD-10) diagnosis code for DLBCL.
- Patients received CAR-T therapy, including both tisa-cel and axi-cel, following DLBCL diagnosis. The administration date of CAR-T therapy was defined as the index date.
- Patients were at least 18 years of age as of the index date.
- Patients had at least three months of continuous health plan enrollment before the index date.
Who cannot join
- Patients who had a medical claim associated with a clinical trial within one month before and after the index date.
- Patients who had zero cost on index date for CAR-T infusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Real-world Study Comparing Tisagenlecleucel (Tisa-cel) With Axicabtagene Ciloleucel (Axi-cel) on Healthcare Resource Use (HRU), Costs, and Overall Survival (OS) in Diffuse Large B-cell Lymphoma (DLBCL): A Retrospective Study of Medicare Population
This was a retrospective non-interventional cohort study design using the Centers for Medicare and Medicaid Services (CMS) 100% Medicare data (2015Q1-2020Q4).
Eligible adult patients with r/r DLBCL who were treated with CAR-T therapy were identified from the CMS 100% Medicare data. Patients who received chimeric antigen receptor modified T cell (CAR-T) therapy were further classified into tisa-cel and axi-cel cohorts based on the type of CAR-T treatment received. The index date was defined as the date of tisa-cel or axi-cel therapy administration. Baseline period was defined as three months prior to the index date. Study period was defined from the index date to the end of health plan coverage based on insurance enrollment file or death, whichever occurred earlier.
- Conditions
- Diffuse Large B-cell Lymphoma
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Tisa-cel cohort | Patients with at least one ICD-10 diagnosis for DLBCL who were at least 18 years old. Patients also had at least three months of continuous health plan enrollment before administration of CAR-T therapy and received tisa-cel following DLBCL diagnosis. | |
| Axi-cel cohort | Patients with at least one ICD-10 diagnosis for DLBCL who were at least 18 years old. Patients also had at least three months of continuous health plan enrollment before administration of CAR-T therapy and received axi-cel following DLBCL diagnosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with IP admission
Measured: Up to approximately 6 years
Number of IP admissions
Measured: Up to approximately 6 years
IP days
Described as the cumulative number of days during IP stays including ICU.
Measured: Up to approximately 6 years
Number of ICU stays
Described as the cumulative number of days during ICU stays.
Measured: Up to approximately 6 years
ICU days
Measured: Up to approximately 6 years
Number of patients with OP visit
OP services include office visits, skilled-nursing facility, home care, durable medical equipment, and other services that are not included in IP stays or ER visits.
Measured: Up to approximately 6 years
Number of OP visits
Measured: Up to approximately 6 years
Number of patients with ER visit
Measured: Up to approximately 6 years
Number of ER visits
Measured: Up to approximately 6 years
Healthcare reimbursement costs
Healthcare reimbursement costs were defined as the amount paid by Medicare to the provider for medical services.
Measured: Up to approximately 6 years
Overall survival (OS)
OS was defined as the time from administration of CAR-T therapy to death due to any cause.
Measured: Up to approximately 6 years
Time to next treatment (TTNT) or death
TTNT was defined as the time from administration of CAR-T therapy to the initiation of the next line of treatment or death due to any cause.
Measured: Up to approximately 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start11 Aug 2022
- Primary completion15 Feb 2023
- Study completion15 Feb 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
- 613 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
- NCT06271369
- Sponsor's protocol ID
- CCTL019CUS13
- Status last verified
- Feb 2024
- First submitted
- 14 Feb 2024
- Last updated
- 21 Feb 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Study Comparing Tisagenlecleucel (Tisa-cel) With Axicabtagene Ciloleucel (Axi-cel) on Healthcare Resource Use (HRU), Costs, and Overall Survival (OS) in Diffuse Large B-cell Lymphoma (DLBCL): A Retrospective Study of Medicare Population
- ClinicalTrials.gov ID
- NCT06271369
- Acronym / sponsor ID
- CCTL019CUS13
- Conditions
- Diffuse Large B-cell Lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 613 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 11 Aug 2022 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 21 Feb 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 was a retrospective non-interventional cohort study design using the Centers for Medicare and Medicaid Services (CMS) 100% Medicare data (2015Q1-2020Q4).
Eligible adult patients with r/r DLBCL who were treated with CAR-T therapy were identified from the CMS 100% Medicare data. Patients who received chimeric antigen receptor modified T cell (CAR-T) therapy were further classified into tisa-cel and axi-cel cohorts based on the type of CAR-T treatment received. The index date was defined as the date of tisa-cel or axi-cel therapy administration. Baseline period was defined as three months prior to the index date. Study period was defined from the index date to the end of health plan coverage based on insurance enrollment file or death, whichever occurred earlier.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tisa-cel cohort | – | –Patients with at least one ICD-10 diagnosis for DLBCL who were at least 18 years old. Patients also had at least three months of continuous health plan enrollment before administration of CAR-T therapy and received tisa-cel following DLBCL diagnosis. |
| Axi-cel cohort | – | –Patients with at least one ICD-10 diagnosis for DLBCL who were at least 18 years old. Patients also had at least three months of continuous health plan enrollment before administration of CAR-T therapy and received axi-cel following DLBCL diagnosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This was a retrospective, noninterventional cohort study.
Key inclusion criteria (4 listed)
- Patients had at least one International Classification of Diseases, 10th Revision (ICD-10) diagnosis code for DLBCL.
- Patients received CAR-T therapy, including both tisa-cel and axi-cel, following DLBCL diagnosis. The administration date of CAR-T therapy was defined as the index date.
- Patients were at least 18 years of age as of the index date.
- Patients had at least three months of continuous health plan enrollment before the index date.
Key exclusion criteria (2 listed)
- Patients who had a medical claim associated with a clinical trial within one month before and after the index date.
- Patients who had zero cost on index date for CAR-T infusion.
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 patients with IP admission
Time frame: Up to approximately 6 years
Number of IP admissions
Time frame: Up to approximately 6 years
IP days
Time frame: Up to approximately 6 years
Described as the cumulative number of days during IP stays including ICU.
Number of ICU stays
Time frame: Up to approximately 6 years
Described as the cumulative number of days during ICU stays.
ICU days
Time frame: Up to approximately 6 years
Number of patients with OP visit
Time frame: Up to approximately 6 years
OP services include office visits, skilled-nursing facility, home care, durable medical equipment, and other services that are not included in IP stays or ER visits.
Number of OP visits
Time frame: Up to approximately 6 years
Number of patients with ER visit
Time frame: Up to approximately 6 years
Number of ER visits
Time frame: Up to approximately 6 years
Healthcare reimbursement costs
Time frame: Up to approximately 6 years
Healthcare reimbursement costs were defined as the amount paid by Medicare to the provider for medical services.
Overall survival (OS)
Time frame: Up to approximately 6 years
OS was defined as the time from administration of CAR-T therapy to death due to any cause.
Time to next treatment (TTNT) or death
Time frame: Up to approximately 6 years
TTNT was defined as the time from administration of CAR-T therapy to the initiation of the next line of treatment or death due to any cause.
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 21 Feb 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, 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 4 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: finished, as of the sponsor's last update on 21 Feb 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 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?
Number of patients with IP admission (time frame: Up to approximately 6 years). 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 21 Feb 2024.