CAR T Cells Real World Evidence Study Based on the French Hospital Claims Data Source (PMSI)
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
1 other identifier
observational
273
1 country
1
Brief Summary
This was a Retrospective cohort study based on the PMSI data source
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 28, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 28, 2021
CompletedFirst Submitted
Initial submission to the registry
April 6, 2022
CompletedFirst Posted
Study publicly available on registry
April 27, 2022
CompletedJuly 1, 2022
June 1, 2022
6 months
April 6, 2022
June 29, 2022
Conditions
Outcome Measures
Primary Outcomes (5)
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).
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.
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.
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.
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
through study completion, approximately 2 years (January 2017 to December 2019)
Study Arms (3)
Adult R/R DLBCL cohort: KYMRIAH
Patients (≥18 years of age) with (relapsed/refractory diffuse large B cell lymphoma \[R/R DLBCL\])
Adult R/R DLBCL cohort: YESCARTA
Patients (≥18 years of age) with (relapsed/refractory diffuse large B cell lymphoma \[R/R DLBCL\])
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
Interventions
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
Patients (≥18 years of age) with (relapsed/refractory diffuse large B cell lymphoma \[R/R DLBCL\])
Eligibility Criteria
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
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Novartis Investigative Site
East Hanover, New Jersey, 07936-1080, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 6, 2022
First Posted
April 27, 2022
Study Start
December 9, 2020
Primary Completion
May 28, 2021
Study Completion
May 28, 2021
Last Updated
July 1, 2022
Record last verified: 2022-06