Diffuse Large B-cell LymphomaNCT05918809
Real-world Resource Use and Costs of CAR-T Therapies in Diffuse Large B-cell Lymphoma (DLBCL): Inpatient and Outpatient Settings
An observational study of Diffuse Large B-cell Lymphoma, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
A retrospective, non-interventional cohort study was used to address the study objectives. This study aimed to provide a better understanding of real-world healthcare resource utilization (HRU) and healthcare reimbursement costs associated with chimeric antigen receptor modified T cell (CAR-T) therapy among patients… 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
- 1,031 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2021to 17 Jun 2022
- 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
- CAR-T cohort:
- Patients had at least one International Classification of Diseases, Tenth Revision (ICD-10) diagnosis code for DLBCL.
- Patients received CAR-T therapy following DLBCL diagnosis. The administration date of CAR-T therapy was defined as the index date. Patients who received both CAR-T therapy and allo-HSCT were classified based on the first treatment that the patient received.
- Patients were at least 18 years of age as of the index date.
- Patients had at least three months of continuous eligibility in the Medicare Part A and Part B data before the index date. Since 2020 Part D data is not available in the current data cut; eligibility requirement in the Part D data was not required.
- Patients were further classified into CAR-T IP and CAR-T OP cohorts depending on where the administration occurred.
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- Allo-HSCT cohort:
- Patients had at least one ICD-10 diagnosis code for DLBCL.
- Patients received allo-HSCT following DLBCL diagnosis. The date of allo-HSCT procedure was defined as the index date. Patients who received both CAR-T therapy and allo-HSCT were classified based on the first treatment the patient received.
- Patients were at least 18 years of age as of the index date.
- Patients had at least three months of continuous eligibility in the Medicare Part A and Part B data before the index date. Since 2020 Part D data is not available in the current data cut; eligibility requirement in the Part D data was not required.
Who cannot join
- Patients had a medical claim associated with a clinical trial (ICD-9 CM code V70.7; ICD-10 CM code Z00.6) during one month before and after the index date.
Trial locations and contacts
1 site in 1 country.
About this study
A retrospective, non-interventional cohort study was used to address the study objectives. This study aimed to provide a better understanding of real-world healthcare resource utilization (HRU) and healthcare reimbursement costs associated with chimeric antigen receptor modified T cell (CAR-T) therapy among patients with DLBCL.
- 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 |
|---|---|---|
| CAR-T IP | Chimeric antigen receptor modified T cells inpatient cohort | |
| CAR-T OP | Chimeric antigen receptor modified T cells outpatient cohort | |
| CAR-T Overall | Chimeric antigen receptor modified T cells overall cohort | |
| allo-HSCT | Allogeneic hematopoietic stem cell transplant cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of hospital admissions in the CAR-T IP and CAR-T OP cohorts
Measured: Up to approximately 10 months
Number of inpatient (IP) days in the CAR-T IP and CAR-T OP cohorts
Measured: Up to approximately 10 months
Number of intensive care unit (ICU) stays in the CAR-T IP and CAR-T OP cohorts
Measured: Up to approximately 10 months
Number of ICU days in the CAR-T IP and CAR-T OP cohorts
Measured: Up to approximately 10 months
Number of emergency room (ER) visits in the CAR-T IP and CAR-T OP cohorts
Measured: Up to approximately 10 months
Number of outpatient (OP) visits in the CAR-T IP and CAR-T OP cohorts
Measured: Up to approximately 10 months
Percentage of patients in the CAR-T IP and CAR-T OP cohorts with any IP admission
Measured: Up to approximately 10 months
Percentage of patients in the CAR-T IP and CAR-T OP cohorts with ER visits
Measured: Up to approximately 10 months
Percentage of patients in the CAR-T IP and CAR-T OP cohorts with OP services
Measured: Up to approximately 10 months
Total pre-infusion healthcare reimbursement costs in the CAR-T IP and CAR-T OP cohorts
Measured: Up to approximately 10 months
Total CAR-T infusion-related healthcare reimbursement costs in the CAR-T IP and CAR-T OP cohorts
Measured: Up to approximately 10 months
Total post-infusion healthcare reimbursement costs in the CAR-T IP and CAR-T OP cohorts
Measured: Up to approximately 10 months
Secondary outcomes (13)
Cumulative percentage of patients admitted in the hospital during the first month after CAR-T OP infusion
Measured: Up to approximately 10 months
Percentage of patients hospitalized each day during the first month after CAR-T infusion among the CAR-T IP and OP cohorts
Measured: Up to approximately 10 months
Main cause of IP admission/re-admission among the CAR-T IP and OP cohorts, up to three months following infusion
Measured: Up to approximately 10 months
Percentage of patients with AEs
Measured: Up to approximately 10 months
Healthcare reimbursement costs per AE event
Measured: Up to approximately 10 months
Number of IP admissions in the overall CAR-T and allo-HSCT cohorts
Measured: Up to approximately 10 months
Number of IP days in the overall CAR-T and allo-HSCT cohorts
Measured: Up to approximately 10 months
Number of OP visits in the overall CAR-T and allo-HSCT cohorts
Measured: Up to approximately 10 months
Number of ER visits in the overall CAR-T and allo-HSCT cohorts
Measured: Up to approximately 10 months
Total healthcare reimbursement costs in the overall CAR-T and allo-HSCT cohorts
Measured: Up to approximately 10 months
Main cause of IP admission/re-admission among the CAR-T IP and OP cohorts
Measured: Up to approximately 10 months
Number of intensive care unit (ICU) stays in the overall CAR-T and allo-HSCT cohorts
Measured: Up to approximately 10 months
Number of ICU days in the overall CAR-T and allo-HSCT cohorts
Measured: Up to approximately 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start25 Jul 2021
- Primary completion17 Jun 2022
- Study completion17 Jun 2022
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
- 1,031 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
- NCT05918809
- Sponsor's protocol ID
- CCTL019CUS11
- Status last verified
- Jun 2023
- First submitted
- 16 Jun 2023
- Last updated
- 26 Jun 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Resource Use and Costs of CAR-T Therapies in Diffuse Large B-cell Lymphoma (DLBCL): Inpatient and Outpatient Settings
- ClinicalTrials.gov ID
- NCT05918809
- Acronym / sponsor ID
- CCTL019CUS11
- Conditions
- Diffuse Large B-cell Lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,031 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 25 Jul 2021 (actual)
- Primary completion
- 17 Jun 2022 (actual)
- Study completion
- 17 Jun 2022 (actual)
- First posted
- 26 Jun 2023 (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.
A retrospective, non-interventional cohort study was used to address the study objectives. This study aimed to provide a better understanding of real-world healthcare resource utilization (HRU) and healthcare reimbursement costs associated with chimeric antigen receptor modified T cell (CAR-T) therapy among patients with DLBCL.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CAR-T IP | – | –Chimeric antigen receptor modified T cells inpatient cohort |
| CAR-T OP | – | –Chimeric antigen receptor modified T cells outpatient cohort |
| CAR-T Overall | – | –Chimeric antigen receptor modified T cells overall cohort |
| allo-HSCT | – | –Allogeneic hematopoietic stem cell transplant cohort |
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 (11 listed)
- Patients had at least one International Classification of Diseases, Tenth Revision (ICD-10) diagnosis code for DLBCL.
- Patients received CAR-T therapy following DLBCL diagnosis. The administration date of CAR-T therapy was defined as the index date. Patients who received both CAR-T therapy and allo-HSCT were classified based on the first treatment that the patient received.
- Patients were at least 18 years of age as of the index date.
- Patients had at least three months of continuous eligibility in the Medicare Part A and Part B data before the index date. Since 2020 Part D data is not available in the current data cut; eligibility requirement in the Part D data was not required.
- Patients were further classified into CAR-T IP and CAR-T OP cohorts depending on where the administration occurred.
Key exclusion criteria (1 listed)
- Patients had a medical claim associated with a clinical trial (ICD-9 CM code V70.7; ICD-10 CM code Z00.6) during one month before and after the index date.
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 hospital admissions in the CAR-T IP and CAR-T OP cohorts
Time frame: Up to approximately 10 months
Number of inpatient (IP) days in the CAR-T IP and CAR-T OP cohorts
Time frame: Up to approximately 10 months
Number of intensive care unit (ICU) stays in the CAR-T IP and CAR-T OP cohorts
Time frame: Up to approximately 10 months
Number of ICU days in the CAR-T IP and CAR-T OP cohorts
Time frame: Up to approximately 10 months
Number of emergency room (ER) visits in the CAR-T IP and CAR-T OP cohorts
Time frame: Up to approximately 10 months
Number of outpatient (OP) visits in the CAR-T IP and CAR-T OP cohorts
Time frame: Up to approximately 10 months
Percentage of patients in the CAR-T IP and CAR-T OP cohorts with any IP admission
Time frame: Up to approximately 10 months
Percentage of patients in the CAR-T IP and CAR-T OP cohorts with ER visits
Time frame: Up to approximately 10 months
Percentage of patients in the CAR-T IP and CAR-T OP cohorts with OP services
Time frame: Up to approximately 10 months
Total pre-infusion healthcare reimbursement costs in the CAR-T IP and CAR-T OP cohorts
Time frame: Up to approximately 10 months
Total CAR-T infusion-related healthcare reimbursement costs in the CAR-T IP and CAR-T OP cohorts
Time frame: Up to approximately 10 months
Total post-infusion healthcare reimbursement costs in the CAR-T IP and CAR-T OP cohorts
Time frame: Up to approximately 10 months
13 secondary outcomes
Cumulative percentage of patients admitted in the hospital during the first month after CAR-T OP infusion
Time frame: Up to approximately 10 months
Percentage of patients hospitalized each day during the first month after CAR-T infusion among the CAR-T IP and OP cohorts
Time frame: Up to approximately 10 months
Main cause of IP admission/re-admission among the CAR-T IP and OP cohorts, up to three months following infusion
Time frame: Up to approximately 10 months
Percentage of patients with AEs
Time frame: Up to approximately 10 months
Healthcare reimbursement costs per AE event
Time frame: Up to approximately 10 months
Number of IP admissions in the overall CAR-T and allo-HSCT cohorts
Time frame: Up to approximately 10 months
Number of IP days in the overall CAR-T and allo-HSCT cohorts
Time frame: Up to approximately 10 months
Number of OP visits in the overall CAR-T and allo-HSCT cohorts
Time frame: Up to approximately 10 months
Number of ER visits in the overall CAR-T and allo-HSCT cohorts
Time frame: Up to approximately 10 months
Total healthcare reimbursement costs in the overall CAR-T and allo-HSCT cohorts
Time frame: Up to approximately 10 months
Main cause of IP admission/re-admission among the CAR-T IP and OP cohorts
Time frame: Up to approximately 10 months
Number of intensive care unit (ICU) stays in the overall CAR-T and allo-HSCT cohorts
Time frame: Up to approximately 10 months
Number of ICU days in the overall CAR-T and allo-HSCT cohorts
Time frame: Up to approximately 10 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 26 Jun 2023.
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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 11 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 26 Jun 2023. 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 hospital admissions in the CAR-T IP and CAR-T OP cohorts (time frame: Up to approximately 10 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 26 Jun 2023.