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
Sponsor study identifier
observational
273
1 country
1
Study Start
December 9, 2020
Actual (reported)Primary Completion
May 28, 2021
Actual (reported)Study Completion
May 28, 2021
Actual (reported)This was a Retrospective cohort study based on the PMSI data source
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 28, 2021
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 9, 2020
Actual (reported)May 28, 2021
Actual (reported)May 28, 2021
Actual (reported)April 6, 2022
Actual (reported)April 27, 2022
Actual (reported)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)
Patients (≥18 years of age) with (relapsed/refractory diffuse large B cell lymphoma \[R/R DLBCL\])
Patients (≥18 years of age) with (relapsed/refractory diffuse large B cell lymphoma \[R/R DLBCL\])
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 \[R/R DLBCL\]) 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 \[R/R DLBCL\])
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
Novartis Investigative Site
East Hanover, New Jersey, 07936-1080, United States
Novartis Pharmaceuticals
Novartis Pharmaceuticals
273 participants (actual enrollment reported by the registry).
First Submitted
April 6, 2022
First Posted
April 27, 2022
Study Start
December 9, 2020
Actual (reported)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)
Contact the study team to confirm eligibility.
Primary Completion
May 28, 2021
Actual (reported)Study Completion
May 28, 2021
Actual (reported)Last Updated
July 1, 2022
Record last verified: 2022-06
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Source: ClinicalTrials.gov.
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