Diffuse Large B-cell Lymphoma (DLBCL)NCT05366257
Real-world Resource Use and Costs of CAR-T Therapies in Diffuse Large B-cell Lymphoma (DLBCL)
An observational study of Diffuse Large B-cell Lymphoma (DLBCL), 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 CAR-T therapy among patients with r/r Diffuse Large B-cell Lymphoma… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Diffuse Large B-cell Lymphoma (DLBCL)
- What is being tested?
- CAR-T and Allo-HSCT cohort
- Type of treatment
- Injection or infusion
- How many people
- 160,602 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2020to 10 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with DLBCL who received CAR-T therapy or allo-HSCT procedure between January 1, 2017 to September 31, 2019
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 2019 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.
Show all 11Show fewer
- 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 2019 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.
United States1 site
Novartis Investigative Site
East Hanover, New Jersey, 07936-1080
About this study
Official title: Real-world Resource Use and Costs of CAR-T Therapies in Diffuse Large B-cell Lymphoma (DLBCL): Inpatient and Outpatient Settings
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 CAR-T therapy among patients with r/r Diffuse Large B-cell Lymphoma (DLBCL).
Read the detailed description
A retrospective, non-interventional cohort study was used to address the study objectives. This study aimed to provide a better understanding of real-world HRU and healthcare reimbursement costs associated with CAR-T therapy among patients with r/r DLBCL.
Eligible adult patients with r/r DLBCL who were treated with CAR-T therapy or allo-HSCT between January 1, 2017 to September 31, 2019 were identified from the Centers for Medicare \& Medicaid Services (CMS) 100% Medicare Database. The CAR-T cohort was further classified into CAR-T IP and CAR-T OP cohorts based on the infusion setting.
The index date was defined as the date of CAR-T therapy administration or allo-HSCT. 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.
Two sets of comparisons on HRU and healthcare reimbursement costs were conducted, one between IP vs. OP infusion of CAR-T, and the other between patients who received CAR-T therapy vs. allo-HSCT.
- Conditions
- Diffuse Large B-cell Lymphoma (DLBCL)
- Being tested
- CAR-T, Allo-HSCT cohort
- Keywords
- CAR-T,, DLBCL,, Inpatient,, Outpatient
- 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.
CAR-TOther
infusion of CAR-T therapy among patients with r/r DLBCL
Allo-HSCT cohortOther
Patients received allogeneic hematopoietic stem cell transplant
| Study group | Role | What they receive |
|---|---|---|
| CAR-T: Inpatient (IP) Cohort | Patients received CAR-T infusion in IP setting Receives: Other: CAR-T | |
| CAR-T: Outpatient (OP) Cohort | Patients received CAR-T infusion in OP setting Receives: Other: CAR-T | |
| Allo-HSCT cohort | Patients received allogeneic hematopoietic stem cell transplant Receives: Other: Allo-HSCT cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean length of follow-up in CAR-T cohorts
Mean length of follow up was reported to compare Health Resource Use (HRU) between IP vs. OP infusion of CAR-T therapy among patients with r/r DLBCL.
Measured: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Number of patients with IP visit in CAR-T cohorts
Number of patients with IP visit were reported to compare Health Resource Use (HRU) between IP vs. OP infusion of CAR-T therapy among patients with r/r DLBCL.
Measured: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Number of IP admissions in CAR-T cohorts
Number of IP admissions were reported to compare Health Resource Use (HRU) between IP vs. OP infusion of CAR-T therapy among patients with r/r DLBCL.
Measured: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Number of IP days in CAR-T cohorts
Number of patients with IP visit were reported to compare Health Resource Use (HRU) between IP vs. OP infusion of CAR-T therapy among patients with r/r DLBCL.
Measured: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Number of ICU stays in CAR-T cohorts
Number of ICU stays were reported to compare Health Resource Use (HRU) between IP vs. OP infusion of CAR-T therapy among patients with r/r DLBCL.
Measured: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Number of ICU days in CAR-T cohorts
Number of ICU days were reported to compare Health Resource Use (HRU) between IP vs. OP infusion of CAR-T therapy among patients with r/r DLBCL.
Measured: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Number of patients with OP visit in CAR-T cohorts
Number of patients with OP visit were reported to compare Health Resource Use (HRU) between IP vs. OP infusion of CAR-T therapy among patients with r/r DLBCL.
Measured: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Number of OP visits in CAR-T cohorts
Number of OP visits were reported to compare Health Resource Use (HRU) between IP vs. OP infusion of CAR-T therapy among patients with r/r DLBCL.
Measured: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Number of patients with ER visit in CAR-T cohorts
Number of patients with ER visit were reported to compare Health Resource Use (HRU) between IP vs. OP infusion of CAR-T therapy among patients with r/r DLBCL.
Measured: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Number of ER visits in CAR-T cohorts
Number of ER visits were reported to compare Health Resource Use (HRU) between IP vs. OP infusion of CAR-T therapy among patients with r/r DLBCL.
Measured: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Total healthcare reimbursement costs in CAR-T cohorts
Total healthcare reimbursement costs, including medical service costs and pharmacy costs, inflated to 2020 US dollars (USD) were reported in CAR-T IP and CAR-T OP cohorts.
Measured: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Secondary outcomes (14)
Mean length of follow-up for CAR-T therapy vs. allo-HSCT cohort
Mean length of follow up was reported to compare Health Resource Use (HRU) of CAR-T therapy vs. allo-HSCT among patients with r/r DLBCL.
Measured: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Number of patients with IP visit in CAR-T vs allo-HSCT cohort
Number of patients with IP visit were reported to compare Health Resource Use (HRU) of CAR-T therapy vs. allo-HSCT among patients with r/r DLBCL.
Measured: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Number of IP admissions in CAR-T therapy vs. allo-HSCT cohort
Number of IP admissions were reported to compare Health Resource Use (HRU) of CAR-T therapy vs. allo-HSCT among patients with r/r DLBCL.
Measured: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Number of IP days in CAR-T therapy vs. allo-HSCT cohort
Number of IP days were reported to compare Health Resource Use (HRU) of CAR-T therapy vs. allo-HSCT among patients with r/r DLBCL.
Measured: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Number of ICU stays in CAR-T therapy vs. allo-HSCT cohort
Number of ICU stays were reported to compare Health Resource Use (HRU) of CAR-T therapy vs. allo-HSCT among patients with r/r DLBCL.
Measured: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Number of ICU days in CAR-T therapy vs. allo-HSCT cohort
Number of ICU days were reported to compare Health Resource Use (HRU) of CAR-T therapy vs. allo-HSCT among patients with r/r DLBCL.
Measured: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Number of patients with OP visit in CAR-T vs allo-HSCT cohort
Number of patients with OP visit were reported to compare Health Resource Use (HRU) of CAR-T therapy vs. allo-HSCT among patients with r/r DLBCL.
Measured: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Number of OP visits in CAR-T therapy vs. allo-HSCT cohort
Number of OP visits were reported to compare Health Resource Use (HRU) of CAR-T therapy vs. allo-HSCT among patients with r/r DLBCL.
Measured: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Number of patients with ER visit in CAR-T vs allo-HSCT cohort
Number of patients with ER visit were reported to compare Health Resource Use (HRU) of CAR-T therapy vs. allo-HSCT among patients with r/r DLBCL.
Measured: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Number of ER visits in CAR-T therapy vs. allo-HSCT cohort
Number of ER visits were reported to compare Health Resource Use (HRU) of CAR-T therapy vs. allo-HSCT among patients with r/r DLBCL.
Measured: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
IP re-admission/admission among CAR-T IP and OP cohorts
IP re-admission/admission were reported to assess post-infusion IP admission/readmission among patients with r/r DLBCL who received CAR-T therapy.
Measured: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
AE rate during the study period among CAR-T cohorts
Rate of adverse events (AEs) were reported among patients with r/r DLBCL who received CAR-T therapy.
Measured: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Cost of AEs among CAR-T cohorts during the study period
Cost per AE event were reported among patients with r/r DLBCL who received CAR-T therapy.
Measured: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Total healthcare reimbursement costs in CAR-T vs allo-HSCT cohort
Total healthcare reimbursement costs, including medical service costs and pharmacy costs, defined as the amount paid by Medicare, inflated to 2020 USD were reported in overall CAR T and allo-HSCT cohorts.
Measured: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start17 Aug 2020
- Primary completion10 May 2021
- Study completion10 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
- 160,602 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
- NCT05366257
- Sponsor's protocol ID
- CCTL019CUS08
- Status last verified
- Jun 2022
- First submitted
- 4 May 2022
- Last updated
- 5 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. 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
- NCT05366257
- Acronym / sponsor ID
- CCTL019CUS08
- Conditions
- Diffuse Large B-cell Lymphoma (DLBCL)
- Keywords
- CAR-T,, DLBCL,, Inpatient,, Outpatient
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160,602 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 17 Aug 2020 (actual)
- Primary completion
- 10 May 2021 (actual)
- Study completion
- 10 May 2021 (actual)
- First posted
- 9 May 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.
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 CAR-T therapy among patients with r/r Diffuse Large B-cell Lymphoma (DLBCL).
Detailed description
A retrospective, non-interventional cohort study was used to address the study objectives. This study aimed to provide a better understanding of real-world HRU and healthcare reimbursement costs associated with CAR-T therapy among patients with r/r DLBCL.
Eligible adult patients with r/r DLBCL who were treated with CAR-T therapy or allo-HSCT between January 1, 2017 to September 31, 2019 were identified from the Centers for Medicare \& Medicaid Services (CMS) 100% Medicare Database. The CAR-T cohort was further classified into CAR-T IP and CAR-T OP cohorts based on the infusion setting.
The index date was defined as the date of CAR-T therapy administration or allo-HSCT. 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.
Two sets of comparisons on HRU and healthcare reimbursement costs were conducted, one between IP vs. OP infusion of CAR-T, and the other between patients who received CAR-T therapy vs. allo-HSCT.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CAR-T: Inpatient (IP) Cohort | – | Other: CAR-TPatients received CAR-T infusion in IP setting |
| CAR-T: Outpatient (OP) Cohort | – | Other: CAR-TPatients received CAR-T infusion in OP setting |
| Allo-HSCT cohort | – | Other: Allo-HSCT cohortPatients received allogeneic hematopoietic stem cell transplant |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with DLBCL who received CAR-T therapy or allo-HSCT procedure between January 1, 2017 to September 31, 2019
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 2019 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAR-Tinfusion of CAR-T therapy among patients with r/r DLBCL | Other | CAR-T: Inpatient (IP) Cohort, CAR-T: Outpatient (OP) Cohort |
| Allo-HSCT cohortPatients received allogeneic hematopoietic stem cell transplant | Other | Allo-HSCT cohort |
Primary outcome
Mean length of follow-up in CAR-T cohorts
Time frame: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Mean length of follow up was reported to compare Health Resource Use (HRU) between IP vs. OP infusion of CAR-T therapy among patients with r/r DLBCL.
Number of patients with IP visit in CAR-T cohorts
Time frame: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Number of patients with IP visit were reported to compare Health Resource Use (HRU) between IP vs. OP infusion of CAR-T therapy among patients with r/r DLBCL.
Number of IP admissions in CAR-T cohorts
Time frame: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Number of IP admissions were reported to compare Health Resource Use (HRU) between IP vs. OP infusion of CAR-T therapy among patients with r/r DLBCL.
Number of IP days in CAR-T cohorts
Time frame: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Number of patients with IP visit were reported to compare Health Resource Use (HRU) between IP vs. OP infusion of CAR-T therapy among patients with r/r DLBCL.
Number of ICU stays in CAR-T cohorts
Time frame: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Number of ICU stays were reported to compare Health Resource Use (HRU) between IP vs. OP infusion of CAR-T therapy among patients with r/r DLBCL.
Number of ICU days in CAR-T cohorts
Time frame: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Number of ICU days were reported to compare Health Resource Use (HRU) between IP vs. OP infusion of CAR-T therapy among patients with r/r DLBCL.
Number of patients with OP visit in CAR-T cohorts
Time frame: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Number of patients with OP visit were reported to compare Health Resource Use (HRU) between IP vs. OP infusion of CAR-T therapy among patients with r/r DLBCL.
Number of OP visits in CAR-T cohorts
Time frame: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Number of OP visits were reported to compare Health Resource Use (HRU) between IP vs. OP infusion of CAR-T therapy among patients with r/r DLBCL.
Number of patients with ER visit in CAR-T cohorts
Time frame: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Number of patients with ER visit were reported to compare Health Resource Use (HRU) between IP vs. OP infusion of CAR-T therapy among patients with r/r DLBCL.
Number of ER visits in CAR-T cohorts
Time frame: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Number of ER visits were reported to compare Health Resource Use (HRU) between IP vs. OP infusion of CAR-T therapy among patients with r/r DLBCL.
Total healthcare reimbursement costs in CAR-T cohorts
Time frame: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Total healthcare reimbursement costs, including medical service costs and pharmacy costs, inflated to 2020 US dollars (USD) were reported in CAR-T IP and CAR-T OP cohorts.
14 secondary outcomes
Mean length of follow-up for CAR-T therapy vs. allo-HSCT cohort
Time frame: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Number of patients with IP visit in CAR-T vs allo-HSCT cohort
Time frame: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Number of IP admissions in CAR-T therapy vs. allo-HSCT cohort
Time frame: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Number of IP days in CAR-T therapy vs. allo-HSCT cohort
Time frame: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Number of ICU stays in CAR-T therapy vs. allo-HSCT cohort
Time frame: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Number of ICU days in CAR-T therapy vs. allo-HSCT cohort
Time frame: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Number of patients with OP visit in CAR-T vs allo-HSCT cohort
Time frame: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Number of OP visits in CAR-T therapy vs. allo-HSCT cohort
Time frame: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Number of patients with ER visit in CAR-T vs allo-HSCT cohort
Time frame: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Number of ER visits in CAR-T therapy vs. allo-HSCT cohort
Time frame: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
IP re-admission/admission among CAR-T IP and OP cohorts
Time frame: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
AE rate during the study period among CAR-T cohorts
Time frame: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Cost of AEs among CAR-T cohorts during the study period
Time frame: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
Total healthcare reimbursement costs in CAR-T vs allo-HSCT cohort
Time frame: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)
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 5 Jul 2022.
- Results for CCTL019CUS08 from the Novartis Clinical Trials Results DatabseLink 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), 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 5 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?
Mean length of follow-up in CAR-T cohorts (time frame: throughout the study, approximately 2 years ( January 1, 2017 to September 31, 2019)). The study lists 11 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 5 Jul 2022.